2013 Patient Assistance and Reimbursement Guide - Association of ...

The Michael and Dianne Bienes Comprehensive 

Cancer Center at Holy Cross Hospital, Florida 

The Association of Community Cancer Centers 

2013 Patient Assistance 

and Reimbursement Guide

SHOULDN’T A PATIENT SUPPORT PROGRAM 

BE EASY TO NAVIGATE 

Connecting your patients who are prescribed 

Jakafi ® (ruxolitinib), and who are eligible for the program, to 

ongoing support and resources during their treatment 

ACCESS AND REIMBURSEMENT SERVICES 

•Benefit verification 

•Prior authorization 

•Appeal support 

•Co-pay assistance 

•Free medication program 

•Referrals and assistance with 

independent not-for-profit 

organizations 

PATIENT EDUCATION AND SUPPORT 

•Access to trained nurses 

•Educational information to help teach your patients 

about their condition 

•Patient packet 

Visit www.IncyteCARES.com or call 1-855-4-JAKAFI (1-855-452-5234) 

Monday–Friday, 8 AM–8 PM ET, to learn more about how to connect 

your patients to IncyteCARES. 

Jakafi is a registered trademark of Incyte Corporation. 

© 2013, Incyte Corporation. All rights reserved. RUX-1227a 04/13


2013 Patient Assistance 

and Reimbursement Guide 

Financial Assistance Along the Cancer Treatment Continuum 4 

by Emmeline Madsen, MPH 

PAP Quick Reference Guide 12 

by Wendalyn Andrews 

PAP Flow Chart 20 

by Wendalyn Andrews 

Pharmaceutical Company Patient Assistance 

and Reimbursement Programs 

Amgen, Inc. 34 

ARIAD Pharmaceuticals, Inc. 36 

Astellas Pharma US, Inc. 37 

Bayer HealthCare Pharmaceuticals, Inc. 39 

Boehringer Ingelheim Pharmaceuticals, Inc. 41 

Bristol-Myers Squibb 42 

Celgene Oncology 44 

Eisai Co., Ltd. 45 

Eli Lilly and Company 47 

EMD Serono 49 

Genentech, Inc. 50 

Genomic Health, Inc. 53 

GlaxoSmithKline 54 

Incyte Corporation 57 

Janssen Biotech 58 

Merck 60 

Millennium: The Takeda Oncology Company 62 

Novartis Pharmaceuticals Corporation 64 

Onyx Pharmaceuticals 66 

Pfizer Oncology 67 

ProStrakan 69 

Sanofi Oncology 71 

Seattle Genetics 73 

TEVA Oncology 74 

Other Patient Assistance Programs and Resources 

BenefitsCheckUp ® 75 

Co-Pay Relief 75 

HealthWell Foundation 75 

The Leukemia & Lymphoma Society 76 

NeedyMeds 77 

Partnership for Prescription Assistance 78 

Patient Access Network Foundation 79 

Patient Advocate Foundation 79 

RxAssist 80 

RxHope 81 

Rx Outreach ® 81 

Together Rx Access ® Card 81 

1 

ACCC 2013 Patient Assistance and Reimbursement Guide

2 

Patient Assistance and Reimbursement Assistance Programs by Drug or Product 

Abraxane ® for Injectable Suspension (paclitaxel 

protein-bound particles for injectable suspension) 44 

Actiq (oral transmucosal fentanyl citrate) [C-II] 74 

Adcetris ® (brentuximab vedotin) for injection 73 

Afinitor ® (everolimus tablets) 64 

Alimta ® (pemetrexed) 47 

Aloxi ® (palonosetron hydrochloride) 45 

Aranesp ® (darbepoetin alfa) 34 

Aromasin ® (exemestane tablets) 67 

Arranon ® (nelarabine) 54 

Arzerra ® (ofatumumab) 54 

Avastin ® (bevacizumab) 50 

Bexxar ® (tositumomab) 54 

Bosulif ® (bosutinib) 67 

Camptosar ® (irinotecan hydrochloride injection) 67 

Dacogen ® (decitabine) for injection 45 

Doxil ® (doxorubicin HCl liposome injection) 58 

Elitek ® (rasburicase) 71 

Ellence ® (epirubicin hydrochloride injection) 67 

Eloxatin ® (oxaliplatin) 71 

Emcyt ® (estramustine phosphate sodium capsules) 67 

Emend ® (aprepitant) 60 

Emend ® (fosaprepitant dimeglumine) for injection 60 

Epogen ® (epoetin alfa) 34 

Erbitux ® (cetuximab) 42 

Erivedge (vismodegib) 50 

Exjade ® (deferasirox) 64 

Fareston ® (toremifene citrate) 69 

Femara ® (letrozole tablets) 64 

Fentora ® (fentanyl buccal tablet) [C-II] 74 

Fragmin ® (dalteparin sodium injection) 45 

Gardasil (Quadrivalent Human Papillomavirus 

Recombinant Vaccine) 60 

Gemzar ® (gemcitabine hydrochloride) 47 

Gleevec ® (imatinib mesylate) tablets 64 

Gliadel ® Wafer (polifeprosan 20 with carmustine 

implant) 45 

Halaven (eribulin mesylate) 45 

Herceptin ® (trastuzumab) 50 

Hexalen ® (altretamine) capsules 45 

Hycamtin ® (topotecan) capsules 54 

Hycamtin ® (topotecan hydrochloride) for injection 54 

Iclusig (ponatinib) 36 

Idamycin ® (idarubicin hydrochloride for injection, 

USP) 67 

Inlyta ® (axitinib) tablets 67 

Intron ® A (interferon alfa-2b, recombinant) for 

injection 60 

Istodax ® (romidepsin) for injection 44 

Ixempra (ixabepilone) 42 

Jakafi ® (ruxolitinib) tablets 57 

Jevtana ® (cabazitaxel) 71 

Kyprolis ® (carfilzomib) for injection 66 

Leukine ® (sargramostim) 71 

Leukeran (chlorambucil) 54 

Mozobil ® (plerixafor injection) 71 

Myleran ® (busulfan) 54 

Neulasta ® (pegfilgrastim) 34 

Neumega ® (oprelvekin) 67 

Neupogen ® (filgrastim) 34 

Nexavar ® (sorafenib) tablets 39 

Nplate ® (romiplostim) 34 

Oncotype DX ® Breast Cancer Assay ® 53 

Oncotype DX ® Colon Cancer Assay ® 53 

Ontak ® (denileukin diftitox) 45 

Perjeta (pertuzumab) 50 

Procrit ® (epoetin alfa) 58 

Prolia ® (denosumab) 34 

Promacta ® (eltrombopag) 54 

Revlimid ® (lenalidomide) 44 

Rituxan ® (rituximab) 50 

Sancuso ® (granisetron transdermal system) 69 

Sandostatin LAR ® Depot (octreotide acetate for 

injectable suspension) 64 

Sandostatin ® (octreotide acetate for injection) 64 

Sensipar ® (cinacalcet) 34 

Sprycel ® (dasatinib) 42 

Stivarga ® (regorafenib) tablets 39 

Sutent ® (sunitinib malate) 67 

Sylatron (peginterferon alfa-2b) for injection 60 

Tarceva ® (erlotinib) 50 

Targretin ® (bexarotene) capsules 45 

Targretin ® (bexarotene) gel 1% 45 

Tasigna ® (nilotinib) tablets 64 

Taxotere ® (docetaxel) 71 

Temodar ® (temozolomide) 60 

Temodar ® (temozolomide) for injection 60 

Thalomid ® (thalidomide) 44 

Thymoglobulin ® (anti-thymocyte globulin [rabbit]) 71 

Torisel ® (temsirolimus) injection 67 

Treanda ® (bendamustine HCl) for injection 74 

Trisenox ® (arsenic trioxide) for injection 74 

Tykerb ® (lapatinib) 54 

Vectibix ® (panitumumab) 34 

Velcade ® (bortezomib) 62 

Vidaza ® (azacitidine) 44 

Votrient (pazopanib) 54 

Xalkori ® (crizotinib) capsules 67 

Xeloda ® (capecitabine) 50 

Xgeva (denosumab) 34 

Xofigo ® (radium Ra 223 dichloride injection) 39 

Xtandi ® (enzalutamide) capsules 37 

Yervoy ® (ipilimumab) 42 

Zaltrap ® (ziv-aflibercept) 71 

Zelboraf ® (vemurafenib) 50 

Zinecard ® (dexrazoxane for injection) 67 

Zolinza (vorinostat) 60 

Zometa ® (zoledronic acid) injection 64 

Zytiga ® (abiraterone acetate) 58 

 


Association of Community Cancer Centers 

National Oncology 

Conference 

October 2-5, 2013 • The Westin Boston 

Boston, Massachusetts 

SAVE THE DATE! 

Details at www.accc-cancer.org/oncologyconference

Financial Assistance Along 

the Cancer Treatment Continuum 

The Rex Healthcare Experience 

by Emmeline Madsen, MPH 

Figure 1. Percentage of 

Uninsured Individuals 

4.4% – 9.9% 

10.0% – 14.0% 

14.1% – 16.0% 

16.1% – 19.0% 

19.1% – 23.7% 

Source: CRS analysis of data from 2010 American 

Community Survey, U.S. Census Bureau. 

4 

 


The number of uninsured Americans under age 65 has grown 

significantly during the economic downturn of recent years. Most 

economists attribute this increase to loss of employment and, 

consequently, employer-sponsored insurance. Those 65 and older 

remain covered by Medicare, and children under 19 years of 

age have maintained coverage because of incremental expansion 

in Medicaid and the Children’s Health Insurance Program. 

According to a November 11, 2011, report from the Congressional 

Research Service (CRS), the total U.S. civilian non-institutionalized 

population in 2010 was slightly more than 304 million. 1 Of those, 47.2 

million (15.5 percent) were uninsured. 1 Percentages by state and an 

average national percentage of uninsured individuals are shown in 

Figure 1, opposite page. In the ranking of percentage of uninsured 

individuals by state, North Carolina ranks thirty-fifth. 2 In addition, 

about 17.9 percent of the U.S. GDP (gross domestic product) is spent 

on healthcare, a figure expected to increase to more than 20 percent 

by 2021. 3 With these daunting figures in mind, it becomes even more 

imperative for healthcare organizations, such as Rex Healthcare, to 

develop financially sound ways to support patients—even when they 

are unable to afford their care. 

Karen Hansen, MSW, oncology 

social worker, Rex Healthcare 

Kimberly Fradel, MSW, LCSW, oncology 

social worker, Rex Healthcare 

The Rex Healthcare 

Response 

Our goal is to provide financial assistance 

to patients for all of the care they receive 

and to ensure ease of patient access to 

care. Every day, Rex Healthcare provides 

more than $100,000 in charity care and 

write-offs. We have an organized financial 

assistance program to help provide 

necessary care for our patients; however, 

these resources are limited to certain 

services and business entities of the Rex 

Healthcare system. 

For example, our financial assistance 

program, Rex Assist, is limited to 

hospital-based services and hospitalemployed 

physician practices. In addition, 

only medically necessary services 

are eligible for charity care consideration. 

Rex Healthcare screens all uninsured 

patients. Patients without health insurance 

are automatically eligible for a 35 

percent discount for qualifying services, 

regardless of income or eligibility for 

charity care. For patients whose income 

is below the U.S. Federal Poverty Guidelines, 

we offer assistance via a contracted 

third party that helps with the Medicaid 

application process and follow-up. If the 

patient does not qualify for Medicaid, our 

staff completes a Rex Assist charity care 

application and forwards it to our Patient 

Financial Services. Criteria are in place 

to determine eligibility. Once approved, 

the patient is eligible for six months and 

the assistance is applicable toward all balances 

incurred prior to the approved Rex 

Assist application. As Rex Healthcare is 

now a member of UNC Healthcare, Rex 

Assist is reciprocal with UNC Hospitals’ 

charity care—saving patients and staff 

additional paperwork and frustration. 

Patients with incomes equal to or less 

than 250 percent of the FPL Guidelines 

receive 100 percent coverage (see 

Table 1, page 6). 

Rex Healthcare physicians and practices 

also participate in Project Access, 

a physician pledge program through the 

Wake County Medical Society that provides 

care to uninsured individuals who 

qualify for the program based on medical 

necessity. For patients who qualify, this 

service, in conjunction with Rex Assist, 

often generates zero financial liability 

5 


Table 1. Patient Eligibility Criteria for Rex Assist 

and offers the additional resources of 

case management and referral within the 

community. 

The Oncology Continuum at 

Rex Healthcare 

Rex Cancer Center was the first in the 

region to earn national recognition as 

a Comprehensive Community Cancer 

Center through the American College of 

Surgeons Commission on Cancer (CoC) 

and was also the first Comprehensive 

Breast Care Center in the area. In addition 

to the Rex Cancer Center, which 

houses medical and radiation oncology, 

many departments within Rex Healthcare 

and several physician practices 

provide care to oncology patients from 

detection to treatment. Because patient 

care spans across these business entities, 

financial assistance is complicated. As 

the patient moves through the cancer care 

continuum many additional bills may be 

generated. Some services do not qualify 

for Rex Financial Assistance; others have 

separate financial assessment and support 

programs. Non-eligible care furthers the 

complexity of resource management for 

patients. Given this complexity, our staff 

works to ensure that patients understand 

the differences in service delivery and 

have access to the appropriate resources 

Forgiveness of Debt 2012 Federal Poverty Traditional Charity 

Guidelines 

Care 100% of Past 

and 6 Months Into 

the Future (Some 

Exceptions Apply) 

% of Federal Poverty 

Guidelines < = 250% 

Family Size of 1 $11,170 $27,925 








For each additional person $3,820 

that are aligned with each service type 

(see Table 2, page 7). 

Navigation Services 

Seven years ago, the Rex Patient Care 

Navigation program was established with 

a Duke Endowment grant to provide 

navigation to breast cancer patients. 

Since then, our program has grown to 

4.7 FTE RNs, providing navigation 

services for those diagnosed with breast, 

gastrointestinal, and thoracic cancers. 

Our navigation team engages with 

patients whenever care is being provided 

within Rex Healthcare. These navigators: 

●● 

Assess patients for financial distress 

●● 

Refer appropriate patients to hospital 

and/or departmental resources 

●● 

Reassure patients about available 

resources 

●● 

Follow up with patients regarding 

the process of accessing financial 

resources. 

Often, our navigators are a trusted source 

of information that patients will turn 

to when reluctant to engage with other 

6 

A Legacy of Philanthropic Care 

In 1894 John Rex, a tanner from 

Raleigh, N.C., made several 

bequests to found Rex Hospital. His 

last will and testament directed: 

I give and bequeath...all 

money belonging to me... 

to provide a comfortable 

retreat for the sick and afflicted 

poor belonging to the 

city of Raleigh in which they 

may have the benefit of 

skillful medical aid and 

proper attention. 

Rex Healthcare has grown from a staff 

of seven working in the converted home 

of former Governor Charles Manly 

to becoming the leading healthcare 

provider for Wake County, N.C., and its 

surrounding communities. 

Now a member of UNC Health 

Care, Rex Healthcare is a private, notfor-profit 

healthcare system with more 

than 5,400 employees. Rex Healthcare 

has 660 beds and treats nearly 34,000 

inpatients annually. Rex Healthcare’s 

medical staff includes more than 

1,100 physicians and 1,700 nurses. 

Wherever patients enter the Rex 

Healthcare system, staff is available 

to address the financial concerns of 

patients and families and ensure that 

they receive the best care possible. 

Rex Healthcare’s mission: to provide 

the best in health services by bringing 

together compassionate care and 

leading-edge technology. Bottom line: 

Rex Healthcare is committed to providing 

the best health services to everyone 

in the communities that we serve— 

regardless of their ability to pay. 

Of course, when John Rex identified 

“the afflicted poor” in his bequest, 

he could not have foreseen the extraordinary 

rise in healthcare costs and 

that these costs would consume 

an enormous percentage of the GDP, 

now at almost 20 percent. Today, 

a tumultuous economy and high 

unemployment have significantly 

reduced the number of people eligible 

for workplace-sponsored insurance, 

and increasing numbers of underinsured 

and uninsured patients enter 

our healthcare system daily to receive 

needed treatment for cancer. 

 


providers. To avoid extensive burden 

on our patient care navigation team, our 

navigators “connect” patients to available 

resources rather than “manage” their 

financial distress. 

Diagnostic Services 

Patients receiving diagnostic services 

within Rex Hospital are eligible for 

Rex Assist. One hallmark program has 

extended diagnostic services for early 

detection further into the community and 

assists with preventive early detection 

for breast cancer. Most other diagnostic 

services within the hospital system are 

linked to suspicious findings rather than 

to routine preventive care. 

If the patient’s diagnostic service 

results in a diagnosis of cancer, the 

patient is contacted the same day by 

the navigation team and provided with 

educational materials and referrals that 

include financial assistance programs. 

Engaging the patient at the start often 

helps allay many fears that come with the 

initial news of a cancer diagnosis. It also 

streamlines the patient’s path to initiating 

care. 

Fortunately, Rex Healthcare has several 

programs that encourage patients to 

manage their breast health proactively— 

even if personal funds are limited. The 

Susan G. Komen Foundation and the Rex 

Healthcare Foundation [a separate 501(c) 

(3) entity] support the Rex Healthcare 

Mammography Certificate Program. 

This program fills an important gap in 

Wake and surrounding counties that 

otherwise do not qualify for state Breast 

and Cervical Cancer Early Detection Program 

funds. Via the Certificate Program, 

medically underserved women in Wake 

and 15 surrounding counties receive 

a screening mammogram through the 

Rex Mobile Mammography Coach and 

Table 2. Services Along the Rex Healthcare Continuum* 

Service Type Technical Fee Professional Fee 

Diagnostic Services Rex Hospital* Private External Practice 

Surgery & Surgical Oncology 

Rex LLC or Private 

External Practice 

Surgical Services Rex Hospital* Rex LLC or Private 

External Practice 

Radiation Oncology 

Radiation Oncology Treatment 

Medical Oncology 

Medical Oncology Treatment 

Rex Hospital* 

Rex Hospital* 

*Services marked with an asterisk are eligible for Rex Assist. 

UNC Healthcare* 

Hospital-Based Practice* 

additional diagnostic imaging through 

the Rex Breast Care Center or its suburban 

sites. To qualify for this program, 

women must have a physician of record, 

be age 35 or older for screening, and 

age 30 or older for diagnostic imaging 

and ultrasound with a physician’s order. 

If a patient then needs an ultrasound 

or biopsy, she is scheduled at the Rex 

Breast Care Center. If results indicate 

that surgery is required, the patient is 

immediately connected with Rex Surgical 

Specialists who accept payment from 

grant funds at the Medicare rate. Physicians 

with Rex Surgical Services are 

not employees of Rex Hospital and their 

agreement with the Breast Care Center is 

key to assuring that women are not only 

screened but treated. 

From April 2010 to March 2011, total 

program expenses for more than 1,500 

women served by the Rex Healthcare 

Mammography Certificate Program 

were $231,480. Funding 

from Susan G. Komen 

during the same time 

period was $74,425, 

or about 23 percent 

of total program 

costs. The remainder 

($157,055) was either 

supported by the Rex 

Healthcare Foundation 

or written off 

as charity care. The 

next year (April 2011 

to March 2012) total 

program costs for about 

2,100 women served 

by the Rex Healthcare 

Mammography Certificate 

Program were 

$329,952. That year, 

Komen contributed 

Table 3. Financial Counseling Team Activities Report for FY 2011 

Month 

Billing 

Questions 

Collection 

Accts. 

Bad 

Debt 

Write-Off 

Balances 

Reviewed 

Active 

Drug 

Assistance 

Active 

Co-pay 


Co-pay 

Cards 

Patients 

with 

Financial 


Chemo Ed 

Sessions 

Totals 837 261 $28,054 8,893 602 306 76 800 251 

Monthly 

Avg. 70 22 $2,338 741 50 26 15 67 21 

7 


8 

two grants: one for surgical expenses 

($26,400) and one for mammography 

($67,500), or 28 percent of total program 

costs. As in the previous year, the 

remaining costs were either reimbursed 

by the Rex Healthcare Foundation or 

considered charity write-offs. 

Surgical Care & Surgical 

Services 

Patients have numerous options for surgical 

management within our community. 

Many surgery practices participate in 

the county-wide Project Access for care, 

however, capacity is limited. A few 

additional resources exist for surgical 

management, but are limited to breast 

cancer care. Patients seeking care with 

Rex Surgical Specialists (a non-Rex 

Hospital business entity) are immediately 

engaged in the Rex Assist program for 

imminent hospital-based charges and are 

also eligible for financial discounts and 

payment plans, based on eligibility, for 

professional fees. 

Radiation Oncology 

& Treatment 

Our radiation oncologists are UNCemployed 

physicians; therefore, patients 

receive a bill from UNC Physicians & 

Associates for professional fees. More 

than two years ago, the charity care 

process was standardized for patients 

whether they received care at Rex Healthcare 

or UNC Healthcare. Prior to that 

time, patients had to complete two separate 

applications for assistance and wait 

for pending approval from both entities. 

Standardizing this process has greatly 

increased efficiency, patient satisfaction, 

and patient compliance with care at both 

institutions. 

Treatment-associated costs for radiation 

oncology are hospital-based charges 

and are eligible for Rex Assist charity 

care. 

Prior to treatment, patients within 

radiation oncology are also provided 

with an estimated cost of care, which is 

aligned with an upfront collections process. 

We refer uninsured individuals or 

patients with concerns about the cost of 

treatment to Rex Assist and our oncology 

social work team. 

Medical Oncology 

& Treatment 

Our medical oncologists are employed by 

Rex Healthcare. As such, patients are eligible 

for Rex Assist for professional fees 

and hospital-based treatment costs. Due 

to the overwhelming cost of therapeutic 

agents, financial counselors meet with 

patients prior to the start of treatment to 

eliminate the financial burden as much 

as possible. The financial counselors 

conduct an assessment to determine 

insurance coverage and potential patient 

liability and identify individuals who 

are self-pay or uninsured (see Figure 2, 

page 9). 

For patients with insurance, prior to 

or during the session, financial counselors 

review: 

✔✔ 

✔✔ 

✔✔ 

Verification of benefits 

Verification of out-of-pocket cost(s) 

Verification of deductible and determination 

if it has been met for that 

plan year. 

For patients who indicate that meeting 

out-of-pocket costs may be difficult, 

financial counselors identify additional 

assistance options, including: 

✔✔ 

✔✔ 

Co-pay assistance programs 

Payment plans. 

For those patients interested in payment 

plans, our team generally adheres to 

amounts per policy, but also maintains 

additional flexibility to lower payments 

to amounts comfortable for the patient. 

For uninsured patients, our financial 

counselors help them in applying for 

Rex Assist (if they have not already 

completed an application) and to reapply 

every six months. Our financial 

counselors also actively pursue assistance 

from pharmaceutical patient assistance 

programs. 

The team tracks the assistance 

that they offer to patients (see Table 3, 

page 7). Not only do these metrics justify 

our financial counselor positions, they 

identify concrete benefits related to 

ongoing financial intervention and case 

management. 

Professional Fees & 

Hospital Charges 

For medical oncology, professional fee 

billing is managed within the practice. 

The financial counselors review accounts 

and write off the eligible amounts linked 

to Rex Assist before sending the account 

to our contracted billing clearinghouse. 

We use our EMR to maintain a list of 

individuals eligible for Rex Assist and 

to generate monthly reports using the 

payer source designated as Rex Assist. 

Most often Rex Assist covers the full 

professional fee costs. However, for those 

accounts with any remaining liability, our 

financial counselors work with patients to 

create payment plans. 

Hospital-based charges are submitted 

for chemotherapy and the associated 

administration and billed by Rex Healthcare 

Patient Financial Services. For those 

charges that have a Rex Assist payer 

source, charges are written off per percentage 

eligibility. Each billing location 

that includes medical oncology reports 

monthly on the amount of charity care. 

Patients can call a toll-free number to 

talk with Rex Patient Financial Services 

customer service team members about 

their bill, potential payment plans, and/ 

or resources to help manage financial 

burdens. Our financial counseling team 

works closely with our social work team 

in this process. 

Pharmaceutical Patient 

Assistance Programs 

After the initial consult, our financial 

counselors use the following process to 

manage self-pay or uninsured patients: 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

Physician writes order 

Chemo order is sent for authorization 

Authorization staff transfer self-pay 

patients to the financial counseling 

team 

Financial counseling team researches 

available patient assistance programs 

based on regimen 

At the Chemo Teaching Session, 

financial counselors work with 

patients to prepare and sign patient 

assistance applications, including 

identifying and gathering the necessary 

financial documents 

Financial counselors complete the 

application with pertinent and available 

information before the Chemo 

Consult with patient 

At the Chemo Consult, financial 

counselors review the final application 

with the patient and obtain final 

signature 

Financial counselors submit applica- 

 


Figure 2. Handout About Our 

Chemotherapy Education 

Session & Financial Assistance 

Engagement 

✔✔ 

tions that same day 

Financial counselors wait for approval 

and follow up as needed outside of 

typical response window. Every effort 

is made to secure eligibility 

and approval before initiation of 

treatment. 

Once approval is received, financial 

counselors proceed based on the type of 

patient assistance program. For programs 

that provide drugs upfront, our financial 

counselors: 

✔✔ 

✔✔ 

✔✔ 

Use chemo orders to ensure that the 

drug is shipped upfront 

Communicate with the oncology 

pharmacy 

Ensure that the pharmacy charge code 

assigned is indicative of the patient 

assistance program 

✔✔ 

Notify Patient Financial Services for 

charge linkage. 

For drug replacement programs, our 

financial counselors: 

✔✔ 

Track drug administration and 

charges 

✔✔ 

Work with the pharmacy department 

and pharmaceutical company to 

replace the drug. 

In the event of any unused drug, our 

financial counselors ensure that the drug 

is reassigned a lot number for indigent 

use; stock used in critical situations 

requires timely initiation of care. 

Each year the number of patients 

receiving patient assistance has grown 

(see Table 4, page 10). To date, we have 

been able to offset these costs with the 

use of pharmaceutical patient assistance 

programs. Our financial counseling 

team is integral in securing this patient 

assistance. Securing approval of free 

chemotherapy drugs from a pharmaceutical 

company is time consuming; 

documentation is often daunting. Our 

financial counselors manage the paperwork 

and logistics 

related to 

each of the 

different 

pharmaceutical 

patient assistance 

programs, along 

with multiple 

grant applications 

and other community 

foundation 

applications. 

For fiscal year 

2011-2012, Rex 

Cancer Center’s 

credits for free 

chemotherapy drugs 

were more than 

$4 million, with 

another $500,000 

in free oral chemotherapy 

drugs. Our 

financial counselors 

were also able to 

obtain grants for 

$132,500 from various 

cancer-specific foundations 

and more than 

$29,000 through co-pay 

assistance cards. 

Inpatient Financial 

Assessment & Assistance 

A third-party contractor, with support 

from the hospital’s social work 

and clinical case management teams, 

assesses and manages our uninsured 

inpatients. Two contract employees 

maintain a daily census list of uninsured 

individuals. The team works 

directly with inpatients to complete 

applications for Medicaid and SSI/SSD. 

Once applications are completed, the 

inpatient is given contact information 

for the contract company. Inpatients are 

assigned an advocate to represent them, 

9 


in person, at any Medicaid appeal hearings. 

Additionally, the inpatient social 

work and case management team make 

assessments and community referrals 

for needed resources. 

For individuals who qualify for 

Medicaid based on disability and/or 

income, our outpatient social work team 

continues to work with those that are 

eligible and/or approved for Medicaid 

and who are receiving ongoing oncology 

care. Given that patients are eligible 

every six months, our team works with 

patients as treatment continues. The team 

also assists the patient with gathering 

all medical bills for proof of continued 

eligibility. 

Outpatient Social Work 

Assessment 

Our oncology social workers routinely 

assess patients receiving outpatient medical 

oncology and radiation oncology to 

Table 4. Increasing Trend of Patients Needing Patient Assistance 

and the Impact on Rex Healthcare 

Number of Patients Amount of Free 

Fiscal Year Receiving Free IV Medicines Drug Received 

2007-2008 29 $1,409,906.49 

2008-2009 29 $1,826,960.85 

2009-2010 40 $2,971,013.55 

2010-2011 46 $2,570,688.74 

2011-2012 60 $4,090,087.40 

2012-2013 YTD 20 $880,619.92 

determine current stressors, which may 

include immediate financial issues exacerbated 

by a cancer diagnosis (see Table 

5, below). In a recent patient assessment, 

when asked about practical concerns and 

issues related to treatment, 260 patients 

named cost of treatment (36 percent), 

insurance (33 percent), employment (20 

percent), and transportation (12 percent). 

Social work assessment and intervention 

includes the following to assess for and 

respond to financial distress: 

●● 

●● 

●● 

●● 

●● 

Identification of barriers to treatment 

Identification of areas of greatest need 

Identification of personal resources 

Identification of community resources 

Assessment of philanthropic Angel 

Fund as gap resource. 

The Rex Healthcare 

Foundation Angel Fund 

After assessment, social workers may 

determine that use of the Rex Healthcare 

Foundation Angel Fund is appropriate to 

meet minimal needs that are identified 

as high-need areas with no identified 

personal or community resources. While 

Table 5. Social Work Encounters to Help Manage Financial Burdens & Assess for Resources* 

Social Work Financial Assistance - Encounters 

July Aug Sept Oct Nov Dec Jan Feb March Apr May June TOTAL AVG 

Medicaid Assistance 15 21 16 24 24 11 25 21 15 13 8 19 212 17.67 

SSI/SSD Assistance 29 35 17 19 24 12 27 13 10 23 12 28 249 20.75 

Rex Assist 20 33 21 24 21 17 22 14 15 21 12 35 255 21.25 

COBRA 2 1 1 1 1 2 1 1 3 13 1 

Transportation 59 61 62 48 62 53 77 61 64 54 43 48 692 57.67 

Angel Fund 78 94 83 80 64 71 100 73 71 60 66 70 910 75.83 

Community Funds 17 11 15 5 12 6 3 4 6 3 5 2 89 7.42 

Community Resources 31 30 34 17 21 22 37 34 30 31 22 30 339 28.25 

*These encounters are in addition to an initial social work assessment to determine patient needs that often reveal financial issues. 

Table 6. Angel Fund Support for FY 2012 

Patients 376 

Average Per Patient $262 

10 

Jul-11 Aug-11 Sep-11 Oct-11 Nov-11 Dec-11 Jan-12 Feb-12 Mar-12 Apr-12 May-12 Jun-12 TOTAL 

$8,920 $12,450 $10,545 $10,295 $6,242 $7,875 $8,273 $6,467 $5,695 $4,038 $7,054 $5,886 $93,738 

 


Case Study 

Rebecca is a 42-year-old married 

mother of two who was 

recently diagnosed with Stage 

III breast cancer. Rebecca has been 

working full-time as a housecleaner 

and trying to work overtime hours, as 

her husband was recently laid off from 

his job. Rebecca is uninsured. It is 

recommended that she have a mastectomy 

followed by chemotherapy and 

radiation. Rebecca is terrified by her 

recent diagnosis, but knows that she is in 

good hands with her medical team. She 

is extremely concerned—not only about 

the medical bills she will incur, but also 

at the thought of how her family will 

survive without income during this time. 

A patient care navigator met with 

Rebecca prior to her surgery to serve 

as her care coordinator for the day of 

surgery and to align resources along 

her anticipated clinical pathway. 

The patient care navigator reassured 

Rebecca that she will be supported 

along her journey—not only by the 

navigation team but also by many other 

skilled clinicians and professionals who 

will help meet her needs. 

The day after Rebecca’s mastectomy 

(while she is an inpatient) she is 

greeted in her room by a representative 

who screens for Medicaid and SSI/ 

SSD programs. Rebecca learns that 

her applications are complete and this 

representative will be her advocate for 

securing these resources. She is also 

given the hospital patient assistance 

application to complete and told about 

how the program may cover a percentage 

of all hospital-based charges. 

Rebecca is told that the surgeon’s fees 

are the only component that will not be 

covered with this program, but that the 

surgical practice will work with her to 

establish a payment plan and identify 

any assistance options. 

Upon presentation for adjuvant 

consultation, financial counselors from 

the cancer center meet with Rebecca 

to complete applications for free drug 

assistance on the day of her chemo 

education session. On Rebecca’s first 

day of chemotherapy, she is greeted by 

the cancer center social worker who 

acknowledges Rebecca’s fears and 

works closely with her throughout treatment 

to ensure that her financial needs 

outside of the medical cost of care are 

met. The oncology social worker links 

Rebecca to the hospital philanthropicsupported 

fund to assist with nominal 

financial needs related to transportation 

and antiemetic drugs, ensuring that 

Rebecca can move easily through her 

treatment. 

The social work team also identifies 

other community resources and 

provides counseling and support to 

Rebecca and her entire family. Rebecca 

and her husband had to make difficult 

choices along the way to treatment, but 

with the help of our financial specialists, 

they feel more than ever that they 

can get through this experience, one 

day at a time. 

a patient is in active treatment, the Angel 

Fund may be used for: 

●● 

Transportation expenses 

●● 

Prescriptions for supportive pharmaceuticals 

(antiemetics and pain 

management) 

●● 

●● 

Nutritional supplements and/or 

prostheses 

Lymphedema supplies. 

With the economic downturn, utilization 

of our Angel Fund was increasing 

at the beginning of FY 2012. To respond 

to the limited capacity of this fund and 

maintain our ability to assist as many 

patients as possible, our social work team 

made the difficult decision to further 

limit the amount per patient. The marked 

decrease in spending after the first third 

of the fiscal year is due to more extensive 

intervention by the social work team 

and a better understanding of resource 

management (see Table 6, page 10). 

The Need & Commitment 

Continues 

As with many healthcare systems, a 

variety of business entities make up 

Rex Healthcare, including hospital 

services and physician-based services. 

Accordingly, patient financial resources 

must cross business lines in a way that 

best and, ideally, consistently provides 

financial resources to patients. While 

this complexity often creates operational 

challenges, we hope to mitigate these 

in the coming years with consistent and 

unified EMRs and billing systems. Rex 

Healthcare is proud of its robust financial 

management for cancer patients 

along the continuum of care, but we 

recognize that there are still unmet 

needs and opportunity for improvement 

and/or integration to a more seamless 

system. UNC Healthcare and Rex 

Healthcare are committed over time to 

providing one bill for all services, thus 

ensuring ease of access for patients. 

However, this goal is not one that will 

be met immediately and will require 

continued resources to achieve. Until 

those additional measures and optimal 

realignment can be put into place, 

Rex Healthcare relies on collaboration 

between its business entities, departments, 

and providers to ensure that 

our patients receive needed care and a 

patient experience that is as seamless as 

possible. 

Emmeline Madsen, MPH, is manager, 

Cancer Specialty Services, Rex Cancer 

Center - Rex/UNC Healthcare, Raleigh, 

N.C. 

References 

1 

Newman D. Health Insurance Coverage 

by State and Congressional District, 2010. 

Congressional Research Service. October 

20, 2011. Available online at: http:// 

healthreformgps.org/wp-content/uploads/ 

health-insurance-coverage-by-statte-and- 

CD-CRS-RPT_R42055_2011-10-201.pdf. 

Last accessed Nov. 7, 2012. 

2 

Mach AL. The Uninsured by State and Congressional 

District, 2010. Penny Hill Press. 

November 17, 2011. 

3 

Centers for Medicare & Medicaid. National 

Health Expenditures Projections, 2011-2021. 

Available online at: www.cms.gov. 

The author would like to thank the following contributors to the article: Rose 

Auman, MSW, support services coordinator; Kimberly Fradel, LCSW, oncology 

social worker; and Wendy Avery, Mobile Mammography coordinator, Rex/UNC 

Healthcare, Raleigh, N.C. 

11 


PAP Quick Reference Guide 

Drug Name Brand Name Drug Company 

Benefit 

Verification 

and 

Authorization 

Support 

Drug 

Company 

Co-Pay 


Foundation 


12 

13-cis-Retinoic Acid Accutane 

2-CdA Leustatin D, H 

2-Chlorodeoxyadenosine Leustatin D, H 

5-Azacitidine Vidaza Celgene X D, H, P 

5FU Adrucil D, H 

6-Mercaptopurine Purinethol H 

6-MP Purinethol H 

6-TG 

Thioguanine Tab 

6-Thioguanine 

Thioguanine Tab 

Actinomycin-D Cosmegen Lundbeck D, H 

Aldesleukin Proleukin Prometheus X 

Alitretinoin Panretin Eisai X 

Altretamine Hexalen Eisai X 

Amifostine Ethyol D, H 

Aminoglutethimide Cytadren H 

Anagrelide 

Agrylin 

Anastrozole Arimidex AstraZeneca A 

Aprepitant Emend Merck X 

ARA-C Cytosar-U H 

Arsenic trioxide Trisenox Teva Oncology X P 

Asparaginase Elspar Merck D, H 

Axitinib Inlynta Pfizer X X X 

ATRA 

Vesanoid 

Azacitidine Vidaza Celgene X D, H, P 

BCG TheraCys Sanofi 

BCNU BiCNU Bristol-Myers Squibb X D, H 

Bendamustine Treanda Teva Oncology X H, P, A, F 

Bexarotene Targretin Eisai X P 

Bevacizumab Avastin Genentech X X D, H, P 

Bicalutamide Casodex AstraZeneca D, R, U 

Bleomycin Blenoxane H 

Bortezomib Velcade Millennium X D, H, P 

Bosutinib Bosulif Pfizer X X X 

Brentuximab vedotin Adcetris Seattle Genetics X X P 

Busulfan Myleran GlaxoSmithKline X H, P 

C225 Erbitux Bristol-Myers Squibb X D, H, P 

Capecitabine Xeloda Genentech X X D, H, P 

Carboplatin Paraplatin H 

Carfilzomib Kyprolis Onyx X X X 

Carmustine BiCNU Bristol-Myers Squibb X D, H 

Chlorambucil Leukeran GlaxoSmithKline X H, P 

Cetuximab Erbitux Bristol-Myers Squibb X D, H, P 

Cisplatin Platinol H 

Cisplatin Platinol-AQ Bristol-Myers Squibb H 

Cladribine Leustatin D, H 

 


Oral 

Prescription 

Savings 

and/or Free 

Medication 

IV & 

Injectable 

Drugs Ongoing 

and/or 

Replacement 

Program 

No Drug 


Phone 

Number 

Website 

H = www.Healthwellfoundation.org 

F = www.patientadvocate.org 

P = www.panfoundation.org/fundingapplication 

D = www.diplomatpharmacy.com/funding 

A = www.pparx.org 

U = www.xubex.com 

M = www.rxoutreach.org 

O = www.rarediseases.org/patients-and-families 

X 

Foundation assistance only. Please see the legend provided. 


X 1.800.931.8691 www.celgenepatientsupport.com 


U 


U 


T 1.800.444.4106 www.togetherrxaccess.com 

T 1.800.444.4106 www.togetherrxaccess.com 

X 1.866.209.7604 www.lundbeck.com/us 

X 1.877.776.5385 www.proleukin.com/mm/resources.aspx 

X 1.866.613.4724 www.eisaireimbursement.com 



1.800.675.8416 www.healthwellfoundation.org 

X 

X 1.800.292.6363 www.astrazeneca-us.com/help-affording-your-medicines 

X X 1.866.363.6379 www.merck.com/merckhelps 


X 1.877.237.4881 www.cephalon.org/cephaloncares-foundation.html 


X 1.877.744.5675 www.pfizerhelpfulanswers.com 

X 


X 1.866.801.5655 www.visitspconline.com 

X 1.800.736.0003 www.bmspaf.org 

X 1.888.587.3263 www.cephalononcologycore.com/ 


X 1.888.249.4918 www.genentech-access.com 



X 1.866.835.2233 www.velcade.com/payingfortreatment.aspx 


X 1.855.473.2436 www.seagensecure.com 

1.866.265.6491 www.gsk-access.com 

X 1.800.861.0048 www.bmsaccesssupport.com 



X 1.855.669.9360 www.kyprolis.com/resources 


1.866.265.6491 www.gsk-access.com 





13 




Benefit 

Verification 


Authorization 

Support 

Drug 

Company 

Co-Pay 


Foundation 


14 

Clofarabine Clolar Genzyme X 

CPT-11 Camptosar Pfizer X D, H, P 

Crizotinib Xalkori Pfizer X 

Cyclophosphamide Cytoxan H 

Cyclophosphamide Neosar H 

Cytarabine Cytosar-U H 

Dactinomycin Cosmegen Lundbeck D, H 

Dacarbazine DTIC H 

Darbepoetin Aranesp Amgen X H, P, F 

Dasatinib Sprycel Bristol-Myers Squibb X 

Daunorubicin 

Cerubidine 

Decitabine Dacogen Eisai X 

Deferasirox Exjade Novartis X 

Degarelix Firmagon Ferring X 

Denileukin diftitox Ontak Eisai X 

Denosumab Prolia Amgen X X H, P, F 

Denosumab Xgeva Amgen X X H, P, F 

Dexrazoxane Totect TopoTarget X X 

Dexrazoxane Zinecard Pfizer X X X 

Docetaxel Taxotere Sanofi X D, H, P 

Doxorubicin Adriamycin H 

Doxorubicin Liposome Doxil Janssen Products X D, H, P 

Eltrombopag Promacta GlaxoSmithKline X X H, A, F, P 

Enzalutamide Xtandi Astellas Oncology X X 

Epirubicin Ellence Pfizer X D, H 

Epoetin Alpha Procrit Janssen Products X D, H 

Erlotinib Tarceva Genentech X X H, P 

Erwinia Asparaginase Elspar D, H 

Estramustine Emcyt Pfizer X X P 

Etoposide Etopophos Bristol-Myers Squibb H 

Etoposide VePesid H 

Etoposide Toposar H 

Everolimus Afinitor Novartis X D, P 

Exemestane Aromasin Pfizer X X H, P, U 

Filgrastim Neupogen Amgen X D, H, P 

Finasteride Proscar Merck M 

Flourouracil 5FU D, H 

Floxuridine FUDR H 

Fludarabine Fludara H, P 

Fluoxymesterone Halotestin H 

Flutamide Eulexin H, P 

Fulvestrant Faslodex AstraZeneca D, H, P 

Gefitinib Iressa AstraZeneca H, P 

Gemcitibine Gemzar Eli Lilly D, H, P 

Gemtuzumab Ozogamicin Mylotarg Pfizer X X H, P, U 

Goserlin Zoladex AstraZeneca D, H, P 

Granisetron Sancuso ProStrakan X X X 

Hydroxyurea Droxia Bristol-Myers Squibb A 

 


Oral 

Prescription 

Savings 


Medication 

IV & 

Injectable 

Drugs Ongoing 


Replacement 

Program 

No Drug 


Phone 

Number 

Website 









X 1.800.792.5652 www.clolar.com/pediatric.asp 






1.866.209.7604 www.lundbeck.com/us 


X 1.888.427.7478 www.AmgenAssistOnline.com 


X 


X 1.888.903.7277 www.oncologyaccessnow.com 

1.877.971.3778 https://firmagon.cmcopilot.com 




1.877.456.4017 www.totect.com/reimbursement.html 




X 1.800.652.6227 www.jjpaf.org 

X 1.866.265.6491 www.caresbygsk.com 

X 1.855.898.2634 www.astellasaccess.com 


X 1.800.652.6227 www.jjpaf.org 










1.800.769.3880 www.rxoutreach.org 








X 1.855.559.8783 www.lillytruassist.com 



1.888.705.7851 www.patientrxsolutions.com 


15 




Benefit 

Verification 


Authorization 

Support 

Drug 

Company 

Co-Pay 


Foundation 


16 

Hydroxyurea Hydrea H, U, M 

Ibritumomab Tiuxetin Zevalin Spectrum X X 

Pharmaceuticals 

Idarubicin Idamycin Pfizer X X X 

Ifosfamide Ifex H 

IL-2 Proleukin Prometheus X 

IL-11 Neumega Pfizer X X X 

Imatinib Gleevec Novartis X D, H, P, F 

Interferon alfa-2a Interferon H 

Interferon alfa-2b Intron A Merck X H, P 

Interleukin-2 Proleukin Prometheus X 

Interleukin-11 Neumega Pfizer X X X 

Irinotecan Camptosar Pfizer X X X 

Isotretinoin 

Accutane 

Ixabepilone Ixempra Bristol-Myers Squibb D, P 

Lapatinib Tykerb GlaxoSmithKline X X D, P 

Lenalidomide Revlimid Celgene X D, H, P 

Letrozole Femara Novartis X H, P, F 

Leucovorin Folinic Acid H 

Leuprolide Eligard Sanofi X D, H 

Leuprolide Acetate Lupron Abbott D, P 

Leuprolide Viadur D, P 

Levoleucovorin Fusilev Spectrum X X 


Mechlorethamine Mustargen Lundbeck H, P 

Megastrol Megace H 

Mephalan Alkeran D, H 

Mesna Mesnex H 

Methotrexate Folex H, U, M 

Methotrexate Rheumatrex H, U, M 

Methotrexate Trexall H, U, M 

Mitomycin Mutamycin D, H, P 

Mitoxantrone Novantrone D, H, P 

Mustine Mustargen Lundbeck H, P 

Nelarabine Arranon GlaxoSmithKline X X H, P, F 

Nilotinib Tasigna Novartis X D, H, P, F 

Nilutamide Nilandron Sanofi P 

Nitrogen Mustard Mustargen Lundbeck H, P 

Octreotide Acetate Sandostatin LAR Novartis X 

Ofatumumab Arzerra GlaxoSmithKline X 

Oprelvekin Neumega Pfizer X X H, P, F 

Oxaliplatin Eloxatin Sanofi X D, H, P 

Paclitaxel Onxal D, H 

Paclitaxel Taxol D, H, A 

Paclitaxel protein-bound Abraxane Celgene X X D, H, P, F 

Palonsetron Aloxi Eisai X 

Pamidronate 

Aredia 

Panitumumab Vectibix Amgen X D, H, P 

Pazopanib Votrient GlaxoSmithKline X X P 

 


Oral 

Prescription 

Savings 


Medication 

IV & 

Injectable 

Drugs Ongoing 


Replacement 

Program 

No Drug 


Phone 

Number 

Website 










X 1.866.298.8433 www.zevalin.com/otherpages/reimbursement-financialsupport.aspx 







X 1.866.363.6379 www.merck.com/merckhelps 




X 


X 1.866.265.6491 www.gsk-access.com 


X 1.800.245.5356 www.patientassistancenow.com 



X 1.800.222.6885 www.abbottpatientassistancefoundation.org 


1.888.537.8377 www.fusilev.com/reimbursement-information 























X 



17 




Benefit 

Verification 


Authorization 

Support 

Drug 

Company 

Co-Pay 


Foundation 


18 

Pegaspargase Oncaspar Sigma-Tau X X 

Pegfilgrastim Neulasta Amgen X X D, H 

Pemetrexed Alimta Eli Lilly D, H, P 

Pentostatin 

Nipent 

Plerixafor Mozobil Sanofi X X D, P 

Plicamycin 

Mithracin 

Ponatinib Iclusig Ariad Pharmaceuticals X X D 

Pralatrexate Folotyn Spectrum X O 


Procarbazine Matulane Sigma-Tau X X H 

Radium Ra 223 dichloride Xofigo Bayer Healthcare X X X 

Rasburicase Elitek Sanofi X H, P, F, O 

Regorafenib Stivarga Bayer Healthcare X X X 

Rituximab Rituxan Genentech X X D, H, P 

Romidepsin Istodax Celgene X P 

Romiplostim Nplate Amgen X X H, P, F 

Ruxolitinib Jakafi Tab Incyte X X X 

Sargramostim Leukine Sanofi X X H 

Sipuleucel-t Provenge Dendreon X P 

Sorafenib Nexavar Bayer Healthcare X X D, P 

Streptozocin 

Zanosar 

Sunitinib Sutent Pfizer X D, P 

Tamoxifen Nolvadex H, M 

Temozolomide Temodar Merck X D 

Temsirolimus Toresel Pfizer X P 

Teniposide Vumon Bristol-Myers Squibb H 

Thalidomide Thalomid Celgene X D, H, P 

Thiotepa Thioplex H 

Topotecan Oral Hycamptin Oral GlaxoSmithKline X X D, H, P 

Topotecan Hycamptin GlaxoSmithKline X X D, H, P 

Toremifene Fareston ProStrakan X X X 

Tositumomab Bexxar GlaxoSmithKline X H 

Trastuzumab Herceptin Genentech X X D, H, P 

Tretinoin (ATRA) Vesanoid Roche X 

Triptorelin Pamoate Trelstar Watson X 

Valrubicin 

Valstar 

Vemurafenib Zelboraf Genentech X X X 

Vinblastine Velban H 

Vincristine Oncovin D, H 

Vincristine sulfate liposome Marqibo Talon 

Vinorelbine Navelbine PF Pharmaceuticals H 

Vorinostat Zolinza Merck X D, P 

VP-16 Etopophos Bristol-Myers Squibb H 

VP-16 VePesid H 

Zidovudine Retrovir X 

Ziv-Aflibercept Zaltrap Sanofi X X 

Zoledronic acid Zometa Novartis X D, P 

 


Oral 

Prescription 

Savings 


Medication 

IV & 

Injectable 

Drugs Ongoing 


Replacement 

Program 

No Drug 


Phone 

Number 

Website 









X 1.800.490.3262 www.sigmatau.com/support/support_oncaspar.asp 


X 1.855.559.8783 www.lillytruassist.com 

X 


X 

X 1.855.447.7277 www.ariadpass.com/healthcare-professional 

X 1.877.272.7102 www.getasapinfo.com 

X 1.800.490.3262 www.sigmatau.com/support/support_oncaspar.asp 

X 1.855.696.3446 www.xofigo-us.com 


X 1.866.639.2827 www.stivarga-us.com/access.html 




X 1.855.452.5234 www.incytecares.com 


X 1.877.336.3736 www.provenge.com/reimbursement.aspx 

X 1.866.639.2827 www.nexavar-us.com 

X 








X 1.866.265.6491 www.commitmenttoaccess.com 

X 1.866.265.6491 www.caresbygsk.com 

X 1.888.705.7851 www.patientsrxsolutions.com 

X 1.866.265.6491 www.commitmenttoaccess.com 


X 1.866.754.3315 www.trelstar.com/hcp-reimbursement-and-support.asp 

X 




X 






X 1.800.245.5356 www.patientassistancenow.com 

The PAP Quick Reference Guide was provided courtesy of Wendalyn Andrews, Practice Manager, 

Hematology and Oncology, The University of Arizona Cancer Center – North Campus. 

19 


PAP Flow Chart 

Step 1 Step 2 Step 3 

Provider writes 

chemotherapy order 

for patient. 

Chemotherapy order 

is sent to finance staff. 

Staff identifies the patient’s 

financial status and follows the 

appropriate flow chart below. 

20 

s s s s s s s s s 

No insurance 

Medicaid Program 

Medicare Only 

Medicare & Supplemental 

Medicare & Secondary 

Medicare Advantage 

Other Government Programs 

Managed Care 

Commercial 

Identify if patient 

qualifies for any programs 

(SSDI, Medicaid, 

etc.). Identify if 

replacement drugs are 

available. 

Verify benefits. 








Fill out forms for all 

programs. Complete 

forms for companies 

that have a replacement 

program if 

patient qualifies. 

Verify drugs are 

indicated for dx 

and authorize if 

necessary. 


indicated for dx. 


indicated for dx. 



and authorize 

secondary insurance 

if necessary. 




necessary. 




necessary. 




necessary. 




necessary. 

Identify if foundation 

funding is available 

for anything not able 

to get replaced. 

Identify if replacement 

drugs are 

available if necessary. 

Will need to appeal 

to receive drugs. 


drugs are 





drugs are 





drugs are 





drugs are 





drugs are 





drugs are 





drugs are 




Fill out forms for 

foundation funding 

that is available. 

Identify patient’s 

responsibility. 




responsibility and 

if there is none start 

treatment. 











 


The PAP Flow Chart was provided courtesy of Wendalyn Andrews, 

Practice Manager, Hematology and Oncology, 

The University of Arizona Cancer Center – North Campus. 

s 


qualifies for charity 

care within the clinic 

or institution and 

complete paperwork. 

Create payment 

plan for any balance 

if available or 

collect balance. 

s s s s s s s s 

Collect out-of-pocket 

costs. 


assistance is available. 

If patient has responsibility, 

identify if 

foundation assistance is 

available. 







Identify if manufacturer 

assistance is 

available and fill out 

forms if applicable. 

Identify if manufacturer 

assistance is 

available and fill out 

forms if applicable. 
















If no manufacturer 

assistance, then 

identify if foundation 

assistance is 

available. 

If no manufacturer 

assistance, then 

identify if foundation 

assistance is 

available. 


qualifies for charity 

care within the clinic 

or institution and 

complete paperwork. 

If patient qualifies, 

send in EOB and/or 

anything else to help 

verify amount for 

foundation to pay. 






















Create payment plan 

for any balance if 

available or collect 

balance. 

If any balance, create 

payment plan or 











If patient qualifies 

for manuafacturer or 

foundation assistance, 



verify amount owed. 

If patient qualifies 

for manuafacturer or 

foundation assistance, 



verify amount owed. 

Process payment 

using co-pay card or 

whatever form of payment 

the program has. 

Process payment 

using co-pay card or 

whatever form of payment 

the program has. 

If any balance create 


collect balance from 

patient. 



collect balance from 

patient. 

21 


SUTENT IN TOUCH: Connecting your patients to our Oncology 

Certified Nurses to help support them during treatment. 

SUTENT IN TOUCH prOvIdES: 

Oncology Certified Nurses (OCNs) —Trained to support your 

SUTENT patients, these nurses provide timely information, including 

tips to help manage certain adverse reactions. 

Tools to Keep Patients on Track —Throughout treatment, patients receive 

calls, e-mails, and mailings timed to align with their treatment schedule. 

yOUr paTIENTS CaN ENrOll by: 

• Returning the business reply card in the 

SUTENT Patient Resource Kit 

• Visiting SUTENT.com/InTouch 

• Calling 1-877-5-SUTENT (1-877-578-8368) 

SUTENT ® (sunitinib malate) is indicated for the treatment of advanced renal cell carcinoma (RCC), gastrointestinal 

stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate, and progressive, well-differentiated 

pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. 

Important Safety Information 

Hepatotoxicity has been observed in clinical trials and post-marketing experience. 

This hepatotoxicity may be severe, and deaths have been reported. 

Monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. SUTENT 

should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. Do not 

restart SUTENT if patients subsequently experience severe changes in liver function tests or have other signs and symptoms 

of liver failure.

S:10 in 

T:10.75 in 

SUTENT ® (sunitinib malate) is indicated for the treatment of 

advanced renal cell carcinoma (RCC), gastrointestinal stromal 

tumor (GIST) after disease progression on or intolerance to 

imatinib mesylate, and progressive, well-differentiated pancreatic 

neuroendocrine tumors (pNET) in patients with unresectable 

locally advanced or metastatic disease. 

Important Safety Information 

Hepatotoxicity has been observed in clinical trials and postmarketing 

experience. This hepatotoxicity may be severe, and 

deaths have been reported. Monitor liver function tests before 

initiation of treatment, during each cycle of treatment, and as 

clinically indicated. SUTENT should be interrupted for Grade 3 

or 4 drug-related hepatic adverse events and discontinued if there 

is no resolution. Do not restart SUTENT if patients subsequently 

experience severe changes in liver function tests or have other 

signs and symptoms of liver failure. 

Women of childbearing potential should be advised of the 

potential hazard to the fetus and to avoid becoming pregnant. 

Given the potential for serious adverse reactions (ARs) in nursing 

infants, a decision should be made whether to discontinue 

nursing or SUTENT. 

Cardiovascular events, including heart failure, myocardial 

disorders, and cardiomyopathy, some of which were fatal, have 

been reported. Monitor patients for signs and symptoms of 

congestive heart failure (CHF) and, in the presence of clinical 

manifestations, discontinuation is recommended. Patients 

who presented with cardiac events, pulmonary embolism, or 

cerebrovascular events within the previous 12 months were 

excluded from clinical studies. 

SUTENT has been shown to prolong QT interval in a dosedependent 

manner, which may lead to an increased risk for 

ventricular arrhythmias including torsades de pointes, which has 

been seen in

HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to use SUTENT safely 

and effectively. See full prescribing information for SUTENT. 

SUTENT ® (sunitinib malate) capsules, oral 

Initial U.S. Approval: 2006 

WARNING: HEPATOTOXICITY 

See full prescribing information for complete boxed warning. 


This hepatotoxicity may be severe, and deaths have been reported. [See Warnings 

and Precautions (5.1)] 

----------------------------------RECENT MAJOR CHANGES---------------------------------- 

Warnings and Precautions, Osteonecrosis of the Jaw (5.7) 4/2012 

Warnings and Precautions, Tumor Lysis Syndrome (5.8) 4/2012 

----------------------------------INDICATIONS AND USAGE---------------------------------- 

SUTENT is a kinase inhibitor indicated for the treatment of: 

• Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance 

to imatinib mesylate. (1.1) 

• Advanced renal cell carcinoma (RCC). (1.2) 

• Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in 

patients with unresectable locally advanced or metastatic disease. (1.3) 

-------------------------------DOSAGE AND ADMINISTRATION------------------------------- 

GIST and RCC: 

• 50 mg orally once daily, with or without food, 4 weeks on treatment followed by 

2 weeks off. (2.1) 

pNET: 

• 37.5 mg orally once daily, with or without food, continuously without a scheduled 

off-treatment period. (2.2) 

Dose Modification: 

• Dose interruptions and/or dose adjustments of 12.5 mg recommended based on 

individual safety and tolerability. (2.3) 

-----------------------------DOSAGE FORMS AND STRENGTHS---------------------------- 

• Capsules: 12.5 mg, 25 mg, 50 mg (3) 

-------------------------------------CONTRAINDICATIONS------------------------------------ 

• None (4) 

-------------------------------WARNINGS AND PRECAUTIONS------------------------------- 

• Hepatotoxicity, including liver failure, has been observed. Monitor liver function 

tests before initiation of treatment, during each cycle of treatment, and as clinically 

indicated. SUTENT should be interrupted for Grade 3 or 4 drug-related hepatic 

adverse events and discontinued if there is no resolution. Do not restart SUTENT if 

patients subsequently experience severe changes in liver function tests or have 

other signs and symptoms of liver failure. (5.1) 

• Women of childbearing potential should be advised of the potential hazard to the 

fetus and to avoid becoming pregnant. (5.2) 

• Cardiac toxicity including left ventricular ejection fraction declines to below the 

lower limit of normal and cardiac failure including death have occurred. Monitor 

patients for signs and symptoms of congestive heart failure. (5.3) 

• Prolonged QT intervals and Torsade de Pointes have been observed. Use with 

caution in patients at higher risk for developing QT interval prolongation. When 

using SUTENT, monitoring with on-treatment electrocardiograms and electrolytes 

should be considered. (5.4) 

• Hypertension may occur. Monitor blood pressure and treat as needed. (5.5) 

• Hemorrhagic events including tumor-related hemorrhage have occurred. Perform 

serial complete blood counts and physical examinations. (5.6) 

• Osteonecrosis of the jaw has been reported. Consider preventive dentistry prior to 

treatment with SUTENT. If possible, avoid invasive dental procedures, particularly 

in patients receiving intravenous bisphosphonate therapy. (5.7) 

• Cases of Tumor Lysis Syndrome (TLS) have been reported primarily in patients 

with RCC and GIST with high tumor burden. Monitor these patients closely and 

treat as clinically indicated. (5.8) 

• Thyroid dysfunction may occur. Patients with signs and/or symptoms suggestive of 

hypothyroidism or hyperthyroidism should have laboratory monitoring of thyroid 

function performed and be treated as per standard medical practice. (5.9) 

• Temporary interruption of therapy with SUTENT is recommended in patients 

undergoing major surgical procedures. (5.10) 

• Adrenal hemorrhage was observed in animal studies. Monitor adrenal function in 

case of stress such as surgery, trauma or severe infection. (5.11) 

------------------------------------ADVERSE REACTIONS------------------------------------- 

• The most common adverse reactions (≥20%) are fatigue, asthenia, fever, diarrhea, 

nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, 

hypertension, peripheral edema, rash, hand-foot syndrome, skin discoloration, dry 

skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity 

pain, cough, dyspnea, anorexia, and bleeding. (6) 

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 

or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

------------------------------------DRUG INTERACTIONS------------------------------------- 

• CYP3A4 Inhibitors: Consider dose reduction of SUTENT when administered with 

strong CYP3A4 inhibitors. (7.1) 

• CYP3A4 Inducers: Consider dose increase of SUTENT when administered with 

CYP3A4 inducers. (7.2) 

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 

Revised: 11/2012 

FULL PRESCRIBING INFORMATION: CONTENTS* 


1 INDICATIONS AND USAGE 

1.1 Gastrointestinal stromal tumor 

1.2 Advanced renal cell carcinoma 

1.3 Advanced pancreatic neuroendocrine tumors 

2 DOSAGE AND ADMINISTRATION 

2.1 Recommended Dose for GIST and RCC 

2.2 Recommended Dose for pNET 

2.3 Dose Modification 

3 DOSAGE FORMS AND STRENGTHS 

4 CONTRAINDICATIONS 

5 WARNINGS AND PRECAUTIONS 

5.1 Hepatotoxicity 

5.2 Pregnancy 

5.3 Left Ventricular Dysfunction 

5.4 QT Interval Prolongation and Torsade de Pointes 

5.5 Hypertension 

5.6 Hemorrhagic Events 

5.7 Osteonecrosis of the Jaw 

5.8 Tumor Lysis Syndrome 

5.9 Thyroid Dysfunction 

5.10 Wound Healing 

5.11 Adrenal Function 

5.12 Laboratory Tests 

6 ADVERSE REACTIONS 

6.1 Adverse Reactions in GIST Study A 

6.2 Adverse Reactions in the Treatment-Naïve RCC Study 

6.3 Adverse Reactions in the Phase 3 pNET Study 

6.4 Venous Thromboembolic Events 

6.5 Reversible Posterior Leukoencephalopathy Syndrome 

6.6 Pancreatic and Hepatic Function 

6.7 Post-marketing Experience 

7 DRUG INTERACTIONS 

7.1 CYP3A4 Inhibitors 

7.2 CYP3A4 Inducers 

7.3 In Vitro Studies of CYP Inhibition and Induction 

8 USE IN SPECIFIC POPULATIONS 

8.1 Pregnancy 

8.3 Nursing Mothers 

8.4 Pediatric Use 

8.5 Geriatric Use 

8.6 Hepatic Impairment 

8.7 Renal Impairment 

10 OVERDOSAGE 

11 DESCRIPTION 

12 CLINICAL PHARMACOLOGY 

12.1 Mechanism of Action 

12.3 Pharmacokinetics 

12.4 Cardiac Electrophysiology 

13 NONCLINICAL TOXICOLOGY 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 

14 CLINICAL STUDIES 

14.1 Gastrointestinal Stromal Tumor 

14.2 Renal Cell Carcinoma 

14.3 Pancreatic Neuroendocrine Tumors 

16 HOW SUPPLIED/STORAGE AND HANDLING 

17 PATIENT COUNSELING INFORMATION 

17.1 Gastrointestinal Disorders 

17.2 Skin Effects 

17.3 Other Common Events 

17.4 Musculoskeletal Disorders 

17.5 Concomitant Medications 

17.6 FDA-Approved Patient Labeling 

* Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION 



This hepatotoxicity may be severe, and deaths have been reported. [See Warnings 

and Precautions (5.1)] 

1 INDICATIONS AND USAGE 

1.1 Gastrointestinal Stromal Tumor (GIST) 

SUTENT is indicated for the treatment of gastrointestinal stromal tumor after disease 

progression on or intolerance to imatinib mesylate. 

1.2 Advanced Renal Cell Carcinoma (RCC) 

SUTENT is indicated for the treatment of advanced renal cell carcinoma. 

1.3 Advanced Pancreatic Neuroendocrine Tumors (pNET) 

SUTENT is indicated for the treatment of progressive, well-differentiated pancreatic 

neuro endocrine tumors in patients with unresectable locally advanced or metastatic 

disease. 

2 DOSAGE AND ADMINISTRATION 

2.1 Recommended Dose for GIST and RCC 

The recommended dose of SUTENT for gastrointestinal stromal tumor (GIST) and 

advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a 

schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). SUTENT may 

be taken with or without food. 

2.2 Recommended Dose for pNET 

The recommended dose of SUTENT for pancreatic neuroendocrine tumors (pNET) is 

37.5 mg taken orally once daily continuously without a scheduled off-treatment period. 

SUTENT may be taken with or without food. 

2.3 Dose Modification 

Dose interruption and/or dose modification in 12.5 mg increments or decrements is 

recommended based on individual safety and tolerability. The maximum dose administered 

in the Phase 3 pNET study was 50 mg daily. 

Strong CYP3A4 inhibitors such as ketoconazole may increase sunitinib plasma 

concentrations. Selection of an alternate concomitant medication with no or minimal 

enzyme inhibition potential is recommended. A dose reduction for SUTENT to a minimum 

of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily should be considered if SUTENT must 

be co-administered with a strong CYP3A4 inhibitor [see Drug Interactions (7.1) and 

Clinical Pharmacology (12.3)]. 

CYP3A4 inducers such as rifampin may decrease sunitinib plasma concentrations. 

Selection of an alternate concomitant medication with no or minimal enzyme induction 

potential is recommended. A dose increase for SUTENT to a maximum of 87.5 mg 

(GIST and RCC) or 62.5 mg (pNET) daily should be considered if SUTENT must be coadministered 

with a CYP3A4 inducer. If dose is increased, the patient should be monitored 

carefully for toxicity [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]. 

3 DOSAGE FORMS AND STRENGTHS 

12.5 mg capsules 

Hard gelatin capsule with orange cap and orange body, printed with white ink “Pfizer” 

on the cap and “STN 12.5 mg” on the body. 

25 mg capsules 

Hard gelatin capsule with caramel cap and orange body, printed with white ink “Pfizer” 

on the cap and “STN 25 mg” on the body. 

50 mg capsules 

Hard gelatin capsule with caramel top and caramel body, printed with white ink 

“Pfizer” on the cap and “STN 50 mg” on the body. 

4 CONTRAINDICATIONS 

None 

5 WARNINGS AND PRECAUTIONS 

5.1 Hepatotoxicity 

SUTENT has been associated with hepatotoxicity, which may result in liver failure or 

death. Liver failure has been observed in clinical trials (7/2281 [0.3%]) and post-marketing 

experience. Liver failure signs include jaundice, elevated transaminases and/or hyperbilirubinemia 

in conjunction with encephalopathy, coagulopathy, and/or renal failure. Monitor 

liver function tests (ALT, AST, bilirubin) before initiation of treatment, during each cycle of 

treatment, and as clinically indicated. SUTENT should be interrupted for Grade 3 or 4 drugrelated 

hepatic adverse events and discontinued if there is no resolution. Do not restart 

SUTENT if patients subsequently experience severe changes in liver function tests or have 

other signs and symptoms of liver failure. 

Safety in patients with ALT or AST >2.5 x ULN or, if due to liver metastases, >5.0 x 

ULN has not been established. 

5.2 Pregnancy 

SUTENT can cause fetal harm when administered to a pregnant woman. As 

angio genesis is a critical component of embryonic and fetal development, inhibition of 

angiogenesis following administration of SUTENT should be expected to result in 

adverse effects on pregnancy. In animal reproductive studies in rats and rabbits, sunitinib 

was teratogenic, embryotoxic, and fetotoxic. There are no adequate and well-controlled 

studies of SUTENT in pregnant women. If this drug is used during pregnancy, or if the 

patient becomes pregnant while taking this drug, the patient should be apprised of the 

potential hazard to a fetus. Women of childbearing potential should be advised to avoid 

becoming pregnant while receiving treatment with SUTENT. 

5.3 Left Ventricular Dysfunction 

In the presence of clinical manifestations of congestive heart failure (CHF), discontinuation 

of SUTENT is recommended. The dose of SUTENT should be interrupted and/or 

reduced in patients without clinical evidence of CHF but with an ejection fraction 20% below baseline. 

Cardiovascular events, including heart failure, myocardial disorders and cardiomyo - 

pathy, some of which were fatal, have been reported through post-marketing experience. 

For GIST and RCC, more patients treated with SUTENT experienced decline in left ventricular 

ejection fraction (LVEF) than patients receiving either placebo or interferon-a (IFN-a). In 

the double-blind treatment phase of GIST Study A, 22/209 patients (11%) on SUTENT and 

3/102 patients (3%) on placebo had treatment-emergent LVEF values below the lower limit 

of normal (LLN). Nine of 22 GIST patients on SUTENT with LVEF changes recovered without 

intervention. Five patients had documented LVEF recovery following intervention (dose 

reduction: one patient; addition of antihypertensive or diuretic medications: four patients). 

Six patients went off study without documented recovery. Additionally, three patients on 

SUTENT had Grade 3 reductions in left ventricular systolic function to LVEF 20% below 

baseline and to below 50%. Left ventricular dysfunction was reported in four patients (1%) 

and CHF in two patients (

eported in post-marketing experience in patients treated with SUTENT for MRCC, GIST and 

metastatic lung cancer. SUTENT is not approved for use in patients with lung cancer. 

Treatment-emergent Grade 3 and 4 tumor hemorrhage occurred in 5/202 patients (3%) 

with GIST receiving SUTENT on Study A. Tumor hemorrhages were observed as early as 

Cycle 1 and as late as Cycle 6. One of these five patients received no further drug following 

tumor hemorrhage. None of the other four patients discontinued treatment or experienced 

dose delay due to tumor hemorrhage. No patients with GIST in the Study A placebo arm 

were observed to undergo intratumoral hemorrhage. Clinical assessment of these events 

should include serial complete blood counts (CBCs) and physical examinations. 

Serious, sometimes fatal gastrointestinal complications including gastrointestinal 

perforation, have occurred rarely in patients with intra-abdominal malignancies treated 

with SUTENT. 

5.7 Osteonecrosis of the Jaw (ONJ) 

ONJ has been observed in clinical trials and has been reported in post-marketing 

experience in patients treated with sunitinib. Concomitant exposure to other risk factors, 

such as bisphosphonates or dental disease, may increase the risk of osteonecrosis of 

the jaw. 

5.8 Tumor Lysis Syndrome (TLS) 

Cases of TLS, some fatal, have been observed in clinical trials and have been reported in 

post-marketing experience, primarily in patients with RCC or GIST treated with SUTENT. 

Patients generally at risk of TLS are those with high tumor burden prior to treatment. 

These patients should be monitored closely and treated as clinically indicated. 

5.9 Thyroid Dysfunction 

Baseline laboratory measurement of thyroid function is recommended and patients 

with hypothyroidism or hyperthyroidism should be treated as per standard medical practice 

prior to the start of SUTENT treatment. All patients should be observed closely for 

signs and symptoms of thyroid dysfunction on SUTENT treatment. Patients with signs 

and/or symptoms suggestive of thyroid dysfunction should have laboratory monitoring of 

thyroid function performed and be treated as per standard medical practice. 

Treatment-emergent acquired hypothyroidism was noted in eight GIST patients (4%) 

on SUTENT versus one (1%) on placebo. Hypothyroidism was reported as an adverse 

reaction in sixty-one patients (16%) on SUTENT in the treatment-naïve RCC study and in 

three patients (1%) in the IFN-a arm. Hypothyroidism was reported as an adverse 

reaction in 6/83 patients (7%) on SUTENT in the Phase 3 pNET study and in 1/82 patients 

(1%) in the placebo arm. 

Cases of hyperthyroidism, some followed by hypothyroidism, have been reported in 

clinical trials and through post-marketing experience. 

5.10 Wound Healing 

Cases of impaired wound healing have been reported during SUTENT therapy. 

Temporary interruption of SUTENT therapy is recommended for precautionary reasons in 

patients undergoing major surgical procedures. There is limited clinical experience regarding 

the timing of reinitiation of therapy following major surgical intervention. Therefore, 

the decision to resume SUTENT therapy following a major surgical intervention should be 

based upon clinical judgment of recovery from surgery. 

5.11 Adrenal Function 

Physicians prescribing SUTENT are advised to monitor for adrenal insufficiency in 

patients who experience stress such as surgery, trauma or severe infection. 

Adrenal toxicity was noted in non-clinical repeat dose studies of 14 days to 9 months 

in rats and monkeys at plasma exposures as low as 0.7 times the AUC observed in clinical 

studies. Histological changes of the adrenal gland were characterized as hemorrhage, 

necrosis, congestion, hypertrophy and inflammation. In clinical studies, CT/MRI obtained 

in 336 patients after exposure to one or more cycles of SUTENT demonstrated no evidence 

of adrenal hemorrhage or necrosis. ACTH stimulation testing was performed in approximately 

400 patients across multiple clinical trials of SUTENT. Among patients with normal 

baseline ACTH stimulation testing, one patient developed consistently abnormal test 

results during treatment that are unexplained and may be related to treatment with 

SUTENT. Eleven additional patients with normal baseline testing had abnormalities in the 

final test performed, with peak cortisol levels of 12-16.4 mcg/dL (normal >18 mcg/dL) 

following stimulation. None of these patients were reported to have clinical evidence of 

adrenal insufficiency. 

5.12 Laboratory Tests 

CBCs with platelet count and serum chemistries including phosphate should be 

performed at the beginning of each treatment cycle for patients receiving treatment 

with SUTENT. 

6 ADVERSE REACTIONS 

The data described below reflect exposure to SUTENT in 660 patients who participated 

in the double-blind treatment phase of a placebo-controlled trial (n=202) for the treatment 

of GIST [see Clinical Studies (14.1)], an active-controlled trial (n=375) for the treatment of 

RCC [see Clinical Studies (14.2)] or a placebo-controlled trial (n=83) for the treatment of 

pNET [see Clinical Studies (14.3)]. The GIST and RCC patients received a starting oral 

dose of 50 mg daily on Schedule 4/2 in repeated cycles, and the pNET patients received a 

starting oral dose of 37.5 mg daily without scheduled off-treatment periods. 

The most common adverse reactions (≥20%) in patients with GIST, RCC or pNET 

are fatigue, asthenia, fever, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, 

abdominal pain, constipation, hypertension, peripheral edema, rash, hand-foot syndrome, 

skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, 

arthralgia, extremity pain, cough, dyspnea, anorexia, and bleeding. The potentially serious 

adverse reactions of hepatotoxicity, left ventricular dysfunction, QT interval prolongation, 

hemorrhage, hypertension, thyroid dysfunction, and adrenal function are discussed in 

Warnings and Precautions (5). Other adverse reactions occurring in GIST, RCC and pNET 

studies are described below. 

Because clinical trials are conducted under widely varying conditions, adverse reaction 

rates observed in the clinical trials of a drug cannot be directly compared to rates in the 

clinical trials of another drug and may not reflect the rates observed in practice. 

6.1 Adverse Reactions in GIST Study A 

Median duration of blinded study treatment was two cycles for patients on SUTENT 

(mean 3.0, range 1-9) and one cycle (mean 1.8, range 1-6) for patients on placebo at the 

time of the interim analysis. Dose reductions occurred in 23 patients (11%) on SUTENT 

and none on placebo. Dose interruptions occurred in 59 patients (29%) on SUTENT and 

31 patients (30%) on placebo. The rates of treatment-emergent, non-fatal adverse 

reactions resulting in permanent discontinuation were 7% and 6% in the SUTENT and 

placebo groups, respectively. 

Most treatment-emergent adverse reactions in both study arms were Grade 1 or 2 in 

severity. Grade 3 or 4 treatment-emergent adverse reactions were reported in 56% versus 

51% of patients on SUTENT versus placebo, respectively, in the double-blind treatment 

phase of the trial. Table 1 compares the incidence of common (≥10%) treatment-emergent 

adverse reactions for patients receiving SUTENT and reported more commonly in patients 

receiving SUTENT than in patients receiving placebo. 

Table 1. Adverse Reactions Reported in Study A in at Least 10% of GIST Patients who 

Received SUTENT in the Double-Blind Treatment Phase and More Commonly Than in 

Patients Given Placebo* 

GIST 

Adverse Reaction, SUTENT (n=202) Placebo (n=102) 

n (%) All Grades Grade 3/4 All Grades Grade 3/4 

Any 114 (56) 52 (51) 

Gastrointestinal 

Diarrhea 81 (40) 9 (4) 27 (27) 0 (0) 

Mucositis/stomatitis 58 (29) 2 (1) 18 (18) 2 (2) 

Constipation 41 (20) 0 (0) 14 (14) 2 (2) 

Cardiac 

Hypertension 31 (15) 9 (4) 11 (11) 0 (0) 

Dermatology 

Skin discoloration 61 (30) 0 (0) 23 (23) 0 (0) 

Rash 28 (14) 2 (1) 9 (9) 0 (0) 

Hand-foot syndrome 28 (14) 9 (4) 10 (10) 3 (3) 

Neurology 

Altered taste 42 (21) 0 (0) 12 (12) 0 (0) 

Musculoskeletal 

Myalgia/limb pain 28 (14) 1 (1) 9 (9) 1 (1) 

Metabolism/Nutrition 

Anorexia a 67 (33) 1 (1) 30 (29) 5 (5) 

Asthenia 45 (22) 10 (5) 11 (11) 3 (3) 

* Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 

a Includes decreased appetite 

In the double-blind treatment phase of GIST Study A, oral pain other than 

mucositis/stomatitis occurred in 12 patients (6%) on SUTENT versus 3 (3%) on placebo. 

Hair color changes occurred in 15 patients (7%) on SUTENT versus 4 (4%) on placebo. 

Alopecia was observed in 10 patients (5%) on SUTENT versus 2 (2%) on placebo. 

Table 2 provides common (≥10%) treatment-emergent laboratory abnormalities. 

Table 2. Laboratory Abnormalities Reported in Study A in at Least 10% of GIST Patients 

Who Received SUTENT or Placebo in the Double-Blind Treatment Phase* 

GIST 

Laboratory SUTENT (n=202) Placebo (n=102) 

Parameter, n (%) All Grades* Grade 3/4* a All Grades* Grade 3/4* b 

Any 68 (34) 22 (22) 


AST / ALT 78 (39) 3 (2) 23 (23) 1 (1) 

Lipase 50 (25) 20 (10) 17 (17) 7 (7) 

Alkaline phosphatase 48 (24) 7 (4) 21 (21) 4 (4) 

Amylase 35 (17) 10 (5) 12 (12) 3 (3) 

Total bilirubin 32 (16) 2 (1) 8 (8) 0 (0) 

Indirect bilirubin 20 (10) 0 (0) 4 (4) 0 (0) 

Cardiac 

Decreased LVEF 22 (11) 2 (1) 3 (3) 0 (0) 

Renal/Metabolic 

Creatinine 25 (12) 1 (1) 7 (7) 0 (0) 

Potassium decreased 24 (12) 1 (1) 4 (4) 0 (0) 

Sodium increased 20 (10) 0 (0) 4 (4) 1 (1) 

Hematology 

Neutrophils 107 (53) 20 (10) 4 (4) 0 (0) 

Lymphocytes 76 (38) 0 (0) 16 (16) 0 (0) 

Platelets 76 (38) 10 (5) 4 (4) 0 (0) 

Hemoglobin 52 (26) 6 (3) 22 (22) 2 (2) 

LVEF=Left ventricular ejection fraction 

* Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 

a Grade 4 laboratory abnormalities in patients on SUTENT included alkaline phosphatase 

(1%), lipase (2%), creatinine (1%), potassium decreased (1%), neutrophils (2%), 

hemoglobin (2%), and platelets (1%). 

b Grade 4 laboratory abnormalities in patients on placebo included amylase (1%), lipase 

(1%), and hemoglobin (2%). 

After an interim analysis, the study was unblinded, and patients on the placebo arm 

were given the opportunity to receive open-label SUTENT treatment [see Clinical Studies 

(14.1)]. For 241 patients randomized to the SUTENT arm, including 139 who received 

SUTENT in both the double-blind and open-label treatment phases, the median duration

of SUTENT treatment was 6 cycles (mean 8.5, range 1 – 44). For the 255 patients who 

ultimately received open-label SUTENT treatment, median duration of study treatment was 

6 cycles (mean 7.8, range 1 – 37) from the time of the unblinding. A total of 118 patients 

(46%) required dosing interruptions, and a total of 72 patients (28%) required dose 

reductions. The incidence of treatment-emergent adverse reactions resulting in permanent 

discontinuation was 20%. The most common Grade 3 or 4 treatment-related adverse 

reactions experienced by patients receiving SUTENT in the open-label treatment phase 

were fatigue (10%), hypertension (8%), asthenia (5%), diarrhea (5%), hand-foot 

syndrome (5%), nausea (4%), abdominal pain (3%), anorexia (3%), mucositis (2%), 

vomiting (2%), and hypothyroidism (2%). 

6.2 Adverse Reactions in the Treatment-Naïve RCC Study 

The as-treated patient population for the treatment-naive RCC study included 735 

patients, 375 randomized to SUTENT and 360 randomized to IFN-a. The median duration 

of treatment was 11.1 months (range: 0.4 – 46.1) for SUTENT treatment and 4.1 months 

(range: 0.1 – 45.6) for IFN-a treatment. Dose interruptions occurred in 202 patients (54%) 

on SUTENT and 141 patients (39%) on IFN-a. Dose reductions occurred in 194 patients 

(52%) on SUTENT and 98 patients (27%) on IFN-a. Discontinuation rates due to adverse 

reactions were 20% for SUTENT and 24% for IFN-a. Most treatment-emergent adverse 

reactions in both study arms were Grade 1 or 2 in severity. Grade 3 or 4 treatmentemergent 

adverse reactions were reported in 77% versus 55% of patients on SUTENT 

versus IFN-a, respectively. 

Table 3 compares the incidence of common (≥10%) treatment-emergent adverse 

reactions for patients receiving SUTENT versus IFN-a. 

Table 3. Adverse Reactions Reported in at Least 10% of Patients with RCC Who 

Received SUTENT or IFN-a* 

Treatment-Naïve RCC 

Adverse Reaction, SUTENT (n=375) IFN-a (n=360) 

n (%) All Grades Grade 3/4 a All Grades Grade 3/4 b 

Any 372 (99) 290 (77) 355 (99) 197 (55) 

Constitutional 

Fatigue 233 (62) 55 (15) 202 (56) 54 (15) 

Asthenia 96 (26) 42 (11) 81 (22) 21 (6) 

Fever 84 (22) 3 (1) 134 (37) 1 (

Table 5. Adverse Reactions Reported in the Phase 3 pNET Study in at Least 10% of 

Patients who Received SUTENT and More Commonly Than in Patients Given Placebo* 

pNET 

Adverse Reaction, SUTENT (n=83) Placebo (n=82) 

n (%) All Grades Grade 3/4 a All Grades Grade 3/4 

Any 82 (99) 45 (54) 78 (95) 41 (50) 

Constitutional 

Asthenia 28 (34) 4 (5) 22 (27) 3 (4) 

Fatigue 27 (33) 4 (5) 22 (27) 7 (9) 

Weight decreased 13 (16) 1(1) 9 (11) 0 (0) 


Diarrhea 49 (59) 4 (5) 32 (39) 2 (2) 

Stomatitis/oral 40 (48) 5 (6) 15 (18) 0 (0) 

Syndromes b 

Nausea 37 (45) 1 (1) 24 (29) 1 (1) 

Abdominal pain c 32 (39) 4 (5) 28 (34) 8 (10) 

Vomiting 28 (34) 0 (0) 25 (31) 2 (2) 

Dyspepsia 12 (15) 0 (0) 5 (6) 0 (0) 

Cardiac 

Hypertension 22 (27) 8 (10) 4 (5) 1 (1) 

Dermatology 

Hair color changes 24 (29) 1 (1) 1 (1) 0 (0) 

Hand-foot syndrome 19 (23) 5 (6) 2 (2) 0 (0) 

Rash 15 (18) 0 (0) 4 (5) 0 (0) 

Dry skin 12 (15) 0 (0) 9 (11) 0 (0) 

Neurology 

Dysgeusia 17 (21) 0 (0) 4 (5) 0 (0) 

Headache 15 (18) 0 (0) 11 (13) 1 (1) 

Musculoskeletal 

Arthralgia 12 (15) 0 (0) 5 (6) 0 (0) 

Psychiatric 

Insomnia 15 (18) 0 (0) 10 (12) 0 (0) 

Hemorrhage/Bleeding 

Bleeding events d 18 (22) 0 (0) 8 (10) 3 (4) 

Epistaxis 17 (21) 1 (1) 4 (5) 0 (0) 

*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 

a Grade 4 ARs in patients on SUTENT included fatigue (1%). 

b Includes aphthous stomatitis, gingival pain, gingivitis, glossitis, glossodynia, mouth 

ulceration, oral discomfort, oral pain, tongue ulceration, mucosal dryness, mucosal 

inflammation, and dry mouth. 

c Includes abdominal discomfort, abdominal pain, and abdominal pain upper. 

d Includes hematemesis, hematochezia, hematoma, hemoptysis, hemorrhage, melena, and 

metrorrhagia. 

Table 6 provides common (≥10%) treatment-emergent laboratory abnormalities. 

Table 6. Laboratory Abnormalities Reported in the Phase 3 pNET Study in at Least 10% 

of Patients Who Received SUTENT 

pNET 

Laboratory SUTENT Placebo 

Parameter, n (%) N All Grades* Grade 3/4* a N All Grades* Grade 3/4* b 


AST increased 82 59 (72) 4 (5) 80 56 (70) 2 (3) 

ALT increased 82 50 (61) 3 (4) 80 44 (55) 2 (3) 

Alkaline phosphatase 82 52 (63) 8 (10) 80 56 (70) 9 (11) 

increased 

Total bilirubin increased 82 30 (37) 1 (1) 80 22 (28) 3 (4) 

Amylase increased 74 15 (20) 3 (4) 74 7 (10) 1 (1) 

Lipase increased 75 13 (17) 4 (5) 72 8 (11) 3 (4) 

Renal/Metabolic 

Glucose increased 82 58 (71) 10 (12) 80 62 (78) 14 (18) 

Albumin decreased 81 33 (41) 1 (1) 79 29 (37) 1 (1) 

Phosphorus decreased 81 29 (36) 6 (7) 77 17 (22) 4 (5) 

Calcium decreased 82 28 (34) 0 (0) 80 15 (19) 0 (0) 

Sodium decreased 82 24 (29) 2 (2) 80 27 (34) 2 (3) 

Creatinine increased 82 22 (27) 4 (5) 80 22 (28) 4 (5) 

Glucose decreased 82 18 (22) 2 (2) 80 12 (15) 3 (4) 

Potassium decreased 82 17 (21) 3 (4) 80 11 (14) 0 (0) 

Magnesium decreased 52 10 (19) 0 (0) 39 4 (10) 0 (0) 

Potassium increased 82 15 (18) 1 (1) 80 9 (11) 1 (1) 

Hematology 

Neutrophils decreased 82 58 (71) 13 (16) 80 13 (16) 0 (0) 

Hemoglobin decreased 82 53 (65) 0 (0) 80 44 (55) 1 (1) 

Platelets decreased 82 49 (60) 4 (5) 80 12 (15) 0 (0) 

Lymphocytes decreased 82 46 (56) 6 (7) 80 28 (35) 3 (4) 

*Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 

a Grade 4 laboratory abnormalities in patients on SUTENT included creatinine (4%), lipase 

(4%), glucose decreased (2%), glucose increased (2%), neutrophils (2%), ALT (1%), AST 

(1%), platelets (1%), potassium increased (1%) and total bilirubin (1%). 

b Grade 4 laboratory abnormalities in patients on placebo included creatinine (3%), alkaline 

phosphatase (1%), glucose increased (1%) and lipase (1%). 

6.4 Venous Thromboembolic Events 

Seven patients (3%) on SUTENT and none on placebo in the double-blind treatment 

phase of GIST Study A experienced venous thromboembolic events; five of the seven were 

Grade 3 deep venous thrombosis (DVT), and two were Grade 1 or 2. Four of these seven 

GIST patients discontinued treatment following first observation of DVT. 

Thirteen (3%) patients receiving SUTENT for treatment-naïve RCC had venous 

thrombo embolic events reported. Seven (2%) of these patients had pulmonary embolism, 

one was Grade 2 and six were Grade 4, and six (2%) patients had DVT, including three 

Grade 3. One patient was permanently withdrawn from SUTENT due to pulmonary 

embolism; dose interruption occurred in two patients with pulmonary embolism and 

one with DVT. In treatment-naïve RCC patients receiving IFN-a, six (2%) venous 

thromboembolic events occurred; one patient (

7.2 CYP3A4 Inducers 

CYP3A4 inducers such as rifampin may decrease sunitinib plasma concentrations. 

Selection of an alternate concomitant medication with no or minimal enzyme induction 

potential is recommended. Concurrent administration of SUTENT with the strong CYP3A4 

inducer, rifampin, resulted in a 23% and 46% reduction in the combined (sunitinib + 

primary active metabolite) C max and AUC 0-∞ values, respectively, after a single dose of 

SUTENT in healthy volunteers. Co-administration of SUTENT with inducers of the CYP3A4 

family (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, 

phenobarbital, St. John’s Wort) may decrease sunitinib concentrations. St. John’s Wort 

may decrease sunitinib plasma concentrations unpredictably. Patients receiving SUTENT 

should not take St. John’s Wort concomitantly. A dose increase for SUTENT should be 

considered when it must be co-administered with CYP3A4 inducers [see Dosage and 

Administration (2.2)]. 

7.3 In Vitro Studies of CYP Inhibition and Induction 

In vitro studies indicated that sunitinib does not induce or inhibit major CYP enzymes. 

The in vitro studies in human liver microsomes and hepatocytes of the activity of CYP 

isoforms CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, 

CYP3A4/5, and CYP4A9/11 indicated that sunitinib and its primary active metabolite are 

unlikely to have any clinically relevant drug-drug interactions with drugs that may be 

metabolized by these enzymes. 

8 USE IN SPECIFIC POPULATIONS 

8.1 Pregnancy 

Pregnancy Category D [see Warnings and Precautions (5.2)]. 

SUTENT can cause fetal harm when administered to a pregnant woman. As 

angiogenesis is a critical component of embryonic and fetal development, inhibition of 

angiogenesis following administration of SUTENT should be expected to result in adverse 

effects on pregnancy. In animal reproductive studies in rats and rabbits, sunitinib was 

teratogenic, embryotoxic, and fetotoxic. There are no adequate and well-controlled 

studies of SUTENT in pregnant women. If this drug is used during pregnancy, or if the 

patient becomes pregnant while taking this drug, the patient should be apprised of the 

potential hazard to a fetus. Women of childbearing potential should be advised to avoid 

becoming pregnant while receiving treatment with SUTENT. 

Sunitinib was evaluated in pregnant rats (0.3, 1.5, 3.0, 5.0 mg/kg/day) and rabbits 

(0.5, 1, 5, 20 mg/kg/day) for effects on the embryo. Significant increases in the incidence of 

embryolethality and structural abnormalities were observed in rats at the dose of 

5 mg/kg/day (approximately 5.5 times the systemic exposure [combined AUC of sunitinib + 

primary active metabolite] in patients administered the recommended daily doses [RDD]). 

Significantly increased embryolethality was observed in rabbits at 5 mg/kg/day while developmental 

effects were observed at ≥1 mg/kg/day (approximately 0.3 times the AUC in patients 

administered the RDD of 50 mg/day). Developmental effects consisted of fetal skeletal malformations 

of the ribs and vertebrae in rats. In rabbits, cleft lip was observed at 1 mg/kg/day and 

cleft lip and cleft palate were observed at 5 mg/kg/day (approximately 2.7 times the AUC in 

patients administered the RDD). Neither fetal loss nor malformations were observed in rats 

dosed at ≤3 mg/kg/day (approximately 2.3 times the AUC in patients administered the RDD). 

Sunitinib (0.3, 1.0, 3.0 mg/kg/day) was evaluated in a pre- and postnatal development 

study in pregnant rats. Maternal body weight gains were reduced during gestation and lactation 

at doses ≥1 mg/kg/day but no maternal reproductive toxicity was observed at doses 

up to 3 mg/kg/day (approximately 2.3 times the AUC in patients administered the RDD). At 

the high dose of 3 mg/kg/day, reduced body weights were observed at birth and persisted 

for offspring of both sexes during the pre-weaning period and in males during post-weaning 

period. No other developmental toxicity was observed at doses up to 3 mg/kg/day 

(approximately 2.3 times the AUC in patients administered the RDD). 

8.3 Nursing Mothers 

Sunitinib and its metabolites are excreted in rat milk. In lactating female rats 

administered 15 mg/kg, sunitinib and its metabolites were extensively excreted in milk at 

concentrations up to 12-fold higher than in plasma. It is not known whether this drug or 

its primary active metabolite are excreted in human milk. Because many drugs are excreted 

in human milk and because of the potential for serious adverse reactions in nursing 

infants from SUTENT, a decision should be made whether to discontinue nursing or to 

discontinue the drug taking into account the importance of the drug to the mother. 

8.4 Pediatric Use 

The safety and efficacy of SUTENT in pediatric patients have not been established. 

Physeal dysplasia was observed in cynomolgus monkeys with open growth plates 

treated for ≥ 3 months (3 month dosing 2, 6, 12 mg/kg/day; 8 cycles of dosing 0.3, 1.5, 

6.0 mg/kg/day) with sunitinib at doses that were > 0.4 times the RDD based on systemic 

exposure (AUC). In developing rats treated continuously for 3 months (1.5, 5.0 and 

15.0 mg/kg) or 5 cycles (0.3, 1.5, and 6.0 mg/kg/day), bone abnormalities consisted of 

thickening of the epiphyseal cartilage of the femur and an increase of fracture of the tibia 

at doses ≥ 5 mg/kg (approximately 10 times the RDD based on AUC). Additionally, caries 

of the teeth were observed in rats at >5 mg/kg. The incidence and severity of physeal 

dysplasia were dose-related and were reversible upon cessation of treatment; however, 

findings in the teeth were not. A no effect level was not observed in monkeys treated 

continuously for 3 months, but was 1.5 mg/kg/day when treated intermittently for 8 cycles. 

In rats the no effect level in bones was ≤ 2 mg/kg/day. 

8.5 Geriatric Use 

Of 825 GIST and RCC patients who received SUTENT on clinical studies, 277 (34%) 

were 65 and over. In the Phase 3 pNET study, 22 (27%) patients who received SUTENT 

were 65 and over. No overall differences in safety or effectiveness were observed between 

younger and older patients. 

8.6 Hepatic Impairment 

No dose adjustment to the starting dose is required when administering SUTENT to 

patients with Child-Pugh Class A or B hepatic impairment. Sunitinib and its primary 

metabolite are primarily metabolized by the liver. Systemic exposures after a single dose 

of SUTENT were similar in subjects with mild or moderate (Child-Pugh Class A and B) 

hepatic impairment compared to subjects with normal hepatic function. SUTENT was not 

studied in subjects with severe (Child-Pugh Class C) hepatic impairment. Studies in 

cancer patients have excluded patients with ALT or AST >2.5 x ULN or, if due to liver 

metastases, >5.0 x ULN. 

8.7 Renal Impairment 

No adjustment to the starting dose is required when administering SUTENT to patients 

with mild, moderate, and severe renal impairment. Subsequent dose modifications should 

be based on safety and tolerability [see Dose Modification (2.3)]. In patients with 

end-stage renal disease (ESRD) on hemodialysis, no adjustment to the starting dose is 

required. However, compared to subjects with normal renal function, the sunitinib exposure 

is 47% lower in subjects with ESRD on hemodialysis. Therefore, the subsequent 

doses may be increased gradually up to 2 fold based on safety and tolerability. 

10 OVERDOSAGE 

Treatment of overdose with SUTENT should consist of general supportive measures. 

There is no specific antidote for overdosage with SUTENT. If indicated, elimination 

of unabsorbed drug should be achieved by emesis or gastric lavage. A few cases of 

accidental overdose have been reported; these cases were associated with adverse 

reactions consistent with the known safety profile of SUTENT, or without adverse reactions. 

A case of intentional overdose involving the ingestion of 1,500 mg of SUTENT in an 

attempted suicide was reported without adverse reaction. In non-clinical studies mortality 

was observed following as few as 5 daily doses of 500 mg/kg (3000 mg/m 2 ) in rats. At this 

dose, signs of toxicity included impaired muscle coordination, head shakes, hypoactivity, 

ocular discharge, piloerection and gastrointestinal distress. Mortality and similar signs of 

toxicity were observed at lower doses when administered for longer durations. 

11 DESCRIPTION 

SUTENT, an oral multi-kinase inhibitor, is the malate salt of sunitinib. Sunitinib 

malate is described chemically as Butanedioic acid, hydroxy-, (2S)-, compound with 

N-[2-(diethylamino)ethyl]-5-[(Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidine)methyl]- 

2,4-dimethyl-1H-pyrrole-3-carboxamide (1:1). The molecular formula is C 22 H 27 FN 4 O 2 • 

C 4 H 6 O 5 and the molecular weight is 532.6 Daltons. 

The chemical structure of sunitinib malate is: 

Sunitinib malate is a yellow to orange powder with a pKa of 8.95. The solubility 

of sunitinib malate in aqueous media over the range pH 1.2 to pH 6.8 is in excess of 

25 mg/mL. The log of the distribution coefficient (octanol/water) at pH 7 is 5.2. 

SUTENT (sunitinib malate) capsules are supplied as printed hard shell capsules 

containing sunitinib malate equivalent to 12.5 mg, 25 mg or 50 mg of sunitinib together 

with mannitol, croscarmellose sodium, povidone (K-25) and magnesium stearate as 

inactive ingredients. 

The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The 

caramel gelatin capsule shells contain titanium dioxide, red iron oxide, yellow iron oxide 

and black iron oxide. The white printing ink contains shellac, propylene glycol, sodium 

hydroxide, povidone and titanium dioxide. 

12 CLINICAL PHARMACOLOGY 

12.1 Mechanism of Action 

Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), 

some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic 

progression of cancer. Sunitinib was evaluated for its inhibitory activity against a variety of 

kinases (>80 kinases) and was identified as an inhibitor of platelet-derived growth factor 

receptors (PDGFRa and PDGFRb), vascular endothelial growth factor receptors (VEGFR1, 

VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), 

colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic 

factor receptor (RET). Sunitinib inhibition of the activity of these RTKs has been 

demonstrated in biochemical and cellular assays, and inhibition of function has been 

demonstrated in cell proliferation assays. The primary metabolite exhibits similar potency 

compared to sunitinib in biochemical and cellular assays. 

Sunitinib inhibited the phosphorylation of multiple RTKs (PDGFRb, VEGFR2, KIT) in 

tumor xenografts expressing RTK targets in vivo and demonstrated inhibition of tumor 

growth or tumor regression and/or inhibited metastases in some experimental models 

of cancer. Sunitinib demonstrated the ability to inhibit growth of tumor cells expressing 

dysregulated target RTKs (PDGFR, RET, or KIT) in vitro and to inhibit PDGFRb- and 

VEGFR2-dependent tumor angiogenesis in vivo. 

12.3 Pharmacokinetics 

The pharmacokinetics of sunitinib and sunitinib malate have been evaluated in 135 

healthy volunteers and in 266 patients with solid tumors. 

Maximum plasma concentrations (C max ) of sunitinib are generally observed between 6 

and 12 hours (T max ) following oral administration. Food has no effect on the bioavailability 

of sunitinib. SUTENT may be taken with or without food. 

Binding of sunitinib and its primary active metabolite to human plasma protein 

in vitro was 95% and 90%, respectively, with no concentration dependence in the range of 

100 – 4000 ng/mL. The apparent volume of distribution (Vd/F) for sunitinib was 2230 L. 

In the dosing range of 25 - 100 mg, the area under the plasma concentration-time curve 

(AUC) and C max increase proportionately with dose. 

Sunitinib is metabolized primarily by the cytochrome P450 enzyme, CYP3A4, 

to produce its primary active metabolite, which is further metabolized by CYP3A4. The 

primary active metabolite comprises 23 to 37% of the total exposure. Elimination is 

primarily via feces. In a human mass balance study of [ 14 C]sunitinib, 61% of the dose was

eliminated in feces, with renal elimination accounting for 16% of the administered dose. 

Sunitinib and its primary active metabolite were the major drug-related compounds 

identified in plasma, urine, and feces, representing 91.5%, 86.4% and 73.8% of radio - 

activity in pooled samples, respectively. Minor metabolites were identified in urine and 

feces but generally not found in plasma. Total oral clearance (CL/F) ranged from 34 to 

62 L/hr with an inter-patient variability of 40%. 

Following administration of a single oral dose in healthy volunteers, the terminal 

half-lives of sunitinib and its primary active metabolite are approximately 40 to 60 hours 

and 80 to 110 hours, respectively. With repeated daily administration, sunitinib accumulates 

3- to 4-fold while the primary metabolite accumulates 7- to 10-fold. Steady-state 

concentrations of sunitinib and its primary active metabolite are achieved within 10 to 14 

days. By Day 14, combined plasma concentrations of sunitinib and its active metabolite 

ranged from 62.9 – 101 ng/mL. No significant changes in the pharmacokinetics of sunitinib 

or the primary active metabolite were observed with repeated daily administration 

or with repeated cycles in the dosing regimens tested. 

The pharmacokinetics were similar in healthy volunteers and in the solid tumor patient 

populations tested, including patients with GIST and RCC. 

Pharmacokinetics in Special Populations 

Population pharmacokinetic analyses of demographic data indicate that there are no 

clinically relevant effects of age, body weight, creatinine clearance, race, gender, or ECOG 

score on the pharmacokinetics of SUTENT or the primary active metabolite. 

Pediatric Use: The pharmacokinetics of SUTENT have not been evaluated in pediatric 

patients. 

Renal Insufficiency: Sunitinib systemic exposure after a single dose of SUTENT was 

similar in subjects with severe renal impairment (CL cr 80 mL/min). Although sunitinib was not eliminated 

through hemodialysis, the sunitinib systemic exposure was 47% lower in subjects with 

ESRD on hemodialysis compared to subjects with normal renal function. 

Hepatic Insufficiency: Systemic exposures after a single dose of SUTENT were similar 

in subjects with mild exocrine (Child-Pugh Class A) or moderate (Child-Pugh Class B) 

hepatic impairment compared to subjects with normal hepatic function. 

12.4 Cardiac Electrophysiology 

See Warnings and Precautions (5.4). 

13 NONCLINICAL TOXICOLOGY 

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 

The carcinogenic potential of sunitinib has been evaluated in two species: rasH2 transgenic 

mice and Sprague-Dawley rats. There were similar positive findings in both species. 

In rasH2 transgenic mice gastroduodenal carcinomas and/or gastric mucosal hyperplasia, 

as well as an increased incidence of background hemangiosarcomas were observed at 

doses of ≥25 mg/kg/day following daily dose administration of sunitinib in studies of 1 or 

6 months duration. No proliferative changes were observed in rasH2 transgenic mice at 

8 mg/kg/day. Similarly, in a 2-year rat carcinogenicity study, administration of sunitinib in 

28-day cycles followed by 7-day dose-free periods resulted in findings of duodenal 

carcinoma at doses as low as 1 mg/kg/day (approximately 0.9 times the AUC in patients 

given the RDD of 50 mg/day). At the high dose of 3 mg/kg/day (approximately 7.8 times 

the AUC in patients at the RDD of 50 mg/day) the incidence of duodenal tumors was 

increased and was accompanied by findings of gastric mucous cell hyperplasia and by an 

increased incidence of pheochromocytoma and hyperplasia of the adrenal. Sunitinib did 

not cause genetic damage when tested in in vitro assays (bacterial mutation [AMES 

Assay], human lymphocyte chromosome aberration) and an in vivo rat bone marrow 

micronucleus test. 

Effects on the female reproductive system were identified in a 3-month repeat dose 

monkey study (2, 6, 12 mg/kg/day), where ovarian changes (decreased follicular development) 

were noted at 12 mg/kg/day (≥5.1 times the AUC in patients administered the RDD), 

while uterine changes (endometrial atrophy) were noted at ≥2 mg/kg/day (≥0.4 times the 

AUC in patients administered the RDD). With the addition of vaginal atrophy, the uterine and 

ovarian effects were reproduced at 6 mg/kg/day in the 9-month monkey study (0.3, 1.5 and 

6 mg/kg/day administered daily for 28 days followed by a 14 day respite; the 6 mg/kg dose 

produced a mean AUC that was ≥0.8 times the AUC in patients administered the RDD). 

A no effect level was not identified in the 3 month study; 1.5 mg/kg/day represents a no 

effect level in monkeys administered sunitinib for 9 months. 

Although fertility was not affected in rats, SUTENT may impair fertility in humans. In 

female rats, no fertility effects were observed at doses of ≤5.0 mg/kg/day [(0.5, 1.5, 

5.0 mg/kg/day) administered for 21 days up to gestational day 7; the 5.0 mg/kg dose 

produced an AUC that was ≥5 times the AUC in patients administered the RDD], however 

significant embryolethality was observed at the 5.0 mg/kg dose. No reproductive effects 

were observed in male rats dosed (1, 3 or 10 mg/kg/day) for 58 days prior to mating with 

untreated females. Fertility, copulation, conception indices, and sperm evaluation 

(morphology, concentration, and motility) were unaffected by sunitinib at doses 

≤10 mg/kg/day (the 10 mg/kg/day dose produced a mean AUC that was ≥25.8 times the 

AUC in patients administered the RDD). 

14 CLINICAL STUDIES 

14.1 Gastrointestinal Stromal Tumor 

GIST Study A 

Study A was a two-arm, international, randomized, double-blind, placebo-controlled 

trial of SUTENT in patients with GIST who had disease progression during prior imatinib 

mesylate (imatinib) treatment or who were intolerant of imatinib. The objective was to 

compare Time-to-Tumor Progression (TTP) in patients receiving SUTENT plus best 

supportive care versus patients receiving placebo plus best supportive care. Other 

objectives included Progression-Free Survival (PFS), Objective Response Rate (ORR), and 

Overall Survival (OS). Patients were randomized (2:1) to receive either 50 mg SUTENT or 

placebo orally, once daily, on Schedule 4/2 until disease progression or withdrawal from 

the study for another reason. Treatment was unblinded at the time of disease progression. 

Patients randomized to placebo were then offered crossover to open-label SUTENT, and 

patients randomized to SUTENT were permitted to continue treatment per investigator 

judgment. 

At the time of a pre-specified interim analysis, the intent-to-treat (ITT) population 

included 312 patients. Two-hundred seven (207) patients were randomized to the SUTENT 

arm, and 105 patients were randomized to the placebo arm. Demographics were 

comparable between the SUTENT and placebo groups with regard to age (69% vs 72% 

There was a statistically significant advantage for SUTENT over IFN-a in the endpoint of 

PFS (see Table 8 and Figure 2). In the pre-specified stratification factors of LDH (>1.5 ULN 

vs. ≤1.5 ULN), ECOG performance status (0 vs. 1), and prior nephrectomy (yes vs. no), 

the hazard ratio favored SUTENT over IFN-a. The ORR was higher in the SUTENT arm (see 

Table 8). 

Table 8. Treatment-Naïve RCC Efficacy Results (interim analysis) 

Efficacy Parameter 

SUTENT IFN-a P-value HR 

(n=375) (n=375) (log-rank test) (95% CI) 

Progression-Free 47.3 22.0

17 PATIENT COUNSELING INFORMATION 

See 17.6 for FDA-Approved Patient Labeling. 

17.1 Gastrointestinal Disorders 

Gastrointestinal disorders such as diarrhea, nausea, stomatitis, dyspepsia, and vomiting 

were the most commonly reported gastrointestinal events occurring in patients who 

received SUTENT. Supportive care for gastrointestinal adverse events requiring treatment 

may include anti-emetic or anti-diarrheal medication. 

17.2 Skin Effects 

Skin discoloration possibly due to the drug color (yellow) occurred in approximately 

one third of patients. Patients should be advised that depigmentation of the hair or skin 

may occur during treatment with SUTENT. Other possible dermatologic effects may 

include dryness, thickness or cracking of skin, blister or rash on the palms of the hands 

and soles of the feet. 

17.3 Other Common Events 

Other commonly reported adverse events included fatigue, high blood pressure, 

bleeding, swelling, mouth pain/irritation and taste disturbance. 

17.4 Musculoskeletal Disorders 

Prior to treatment with SUTENT, a dental examination and appropriate preventive dentistry 

should be considered. In patients being treated with SUTENT, who have previously 

received or are receiving bisphosphonates, invasive dental procedures should be avoided, 

if possible. 

17.5 Concomitant Medications 

Patients should be advised to inform their health care providers of all concomitant 

medications, including over-the-counter medications and dietary supplements [see Drug 

Interactions (7)]. 

17.6 FDA-Approved Patient Labeling 

LAB-0317-17.0 

Distributed by 

Pfizer Labs 

Division of Pfizer Inc, NY, NY 10017 

MEDICATION GUIDE 

SUTENT (su TENT) 

(sunitinib malate) 

capsules 

Read the Medication Guide that comes with SUTENT before you start taking 

it and each time you get a refill. There may be new information. This 

Medication Guide does not take the place of talking to your healthcare 

provider about your medical condition or treatment. If you have any 

questions about SUTENT, ask your healthcare provider or pharmacist. 

What is the most important information I should know about SUTENT 

SUTENT can cause serious liver problems, including death. 

• Tell your healthcare provider right away if you develop any of the 

following signs and symptoms of liver problems during treatment 

with SUTENT: 

• itching 

• yellow eyes or skin, 

• dark urine, and 

• pain or discomfort in the right upper stomach area. 

• Your healthcare provider should do blood tests to check your liver 

function before you start taking SUTENT and during treatment. 

What is SUTENT 

SUTENT is a prescription medicine used to treat people with: 

• a rare cancer of the stomach, bowel, or esophagus called GIST 

(gastrointestinal stromal tumor) and when: 

• the medicine Gleevec ® (imatinib mesylate) did not stop the 

cancer from growing, or 

• you cannot take Gleevec ® . 

• advanced kidney cancer (advanced renal cell carcinoma or RCC) 

• a type of pancreatic cancer known as pancreatic neuroendocrine 

tumors (pNET), that has progressed and cannot be treated with 

surgery. 

It is not known if SUTENT is safe and effective in children. 

What should I tell my healthcare provider before taking SUTENT 

Before taking SUTENT tell your healthcare provider if you: 

• have any heart problems 

• have high blood pressure 

• have thyroid problems 

• have kidney function problems (other than cancer) 

• have liver problems 

• have any bleeding problem 

• have seizures 

• have or have had pain in the mouth, teeth or jaw, swelling or sores inside 

the mouth, numbness or a feeling of heaviness in the jaw, or loosening of 

a tooth 

• have any other medical conditions 

• are pregnant, could be pregnant or plan to become pregnant. SUTENT may 

harm an unborn baby. You should not become pregnant while taking 

SUTENT. Tell your healthcare provider right away if you become pregnant 

while taking SUTENT. 

• are breastfeeding or plan to breastfeed. You and your healthcare provider 

should decide if you will take SUTENT or breastfeed. You should not do both. 

Tell all of your healthcare providers and dentists that you are taking SUTENT. 

They should talk to the healthcare provider who prescribed SUTENT for you, 

before you have any surgery, or medical or dental procedure. 

Tell your healthcare provider about all the medicines you take, including 

prescription medicines and non-prescription medicines, vitamins, and herbal 

supplements. Using SUTENT with certain other medicines can cause serious 

side effects. 

You may have an increased risk of severe jaw bone problems (osteonecrosis) 

if you take SUTENT and a bisphosphonate medicine. Especially tell your 

healthcare provider if you are taking or have taken Actonel, Aredia, Boniva, 

Didronel, Fosamax, Reclast, Skelid or Zometa.

Know the medicines you take. Keep a list of them to show your healthcare 

provider and pharmacist when you get a new medicine. Talk with your healthcare 

provider before starting any new medicines. 

How should I take SUTENT 

• Take SUTENT exactly the way your healthcare provider tells you. 

• Take SUTENT 1 time each day with or without food. 

• If you take SUTENT for GIST or RCC, you will usually take your medicine for 

4 weeks (28 days) and then stop for 2 weeks (14 days). This is 1 cycle of 

treatment. You will repeat this cycle for as long as your healthcare provider 

tells you to. 

• If you take SUTENT for pNET, take it one time each day until your healthcare 

provider tells you to stop. 

• Do not open the SUTENT capsules. 

• Do not drink grapefruit juice or eat grapefruit during your treatment with 

SUTENT. They may cause you to have too much SUTENT in your body. 

• Your healthcare provider may do blood tests before each cycle of 

treatment. 

• If you miss a dose, take it as soon as you remember. Do not take it if it is 

close to your next dose. Just take the next dose at your regular time. Do not 

take more than 1 dose of SUTENT at a time. Tell your healthcare provider 

about any missed dose. 

• Call your healthcare provider right away, if you take too much SUTENT. 

What are possible side effects of SUTENT 

SUTENT may cause serious side effects including: 

• See “What is the most important information I should know about 

SUTENT” 

• Heart problems. Heart problems may include heart failure and heart 

muscle problems (cardiomyopathy) that can lead to death. Tell your 

healthcare provider if you feel very tired, are short of breath, or have 

swollen feet and ankles. 

• Abnormal heart rhythm changes. Your healthcare provider may do 

electrocardiograms and blood tests to watch for these problems during 

your treatment with SUTENT. Tell your healthcare provider if you feel dizzy, 

faint, or have abnormal heartbeats while taking SUTENT. 

• High blood pressure. Your healthcare provider may check your blood 

pressure during treatment with SUTENT. Your healthcare provider may 

prescribe medicine for you to treat high blood pressure, if needed. 

• Bleeding sometimes leading to death. Tell your healthcare provider right 

away if you have any of these symptoms or a serious bleeding problem 

during treatment with SUTENT. 

• painful, swollen stomach (abdomen) 

• vomiting blood 

• black, sticky stools 

• bloody urine 

• headache or change in your mental status 

Your healthcare provider can tell you other symptoms to watch for. 

• Jaw-bone problems (osteonecrosis) Severe jaw bone problems may 

happen when you take SUTENT. Your healthcare provider should examine 

your mouth before you start SUTENT. Your healthcare provider may tell you 

to see your dentist before you start SUTENT. 

• Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of 

cancer cells and may lead to death. TLS may cause you to have nausea, 

shortness of breath, irregular heartbeat, clouding of urine and tiredness 

associated with abnormal laboratory test results (high potassium, uric acid 

and phosphorous levels and low calcium levels in the blood) that can lead 

to changes in kidney function and acute kidney failure. Your healthcare 

provider may do blood tests to check you for TLS. 

• Hormone problems, including thyroid and adrenal gland problems. Your 

healthcare provider may do tests to check your thyroid and adrenal gland 

function during SUTENT treatment. Tell your doctor if you have any of the 

following signs and symptoms during treatment with SUTENT: 

• tiredness that worsens and does not go away 

• loss of appetite 

• heat intolerance 

• feeling nervous or agitated, tremors 

• sweating 

• nausea or vomiting 

• diarrhea 

• fast heart rate 

• weight gain or weight loss 

• feeling depressed 

• irregular menstrual periods or no menstrual periods 

• headache 

• hair loss 

Common side effects of SUTENT include: 

• The medicine in SUTENT is yellow, and it may make your skin look 

yellow. Your skin and hair may get lighter in color. 

• tiredness 

• weakness 

• fever 

• gastrointestinal symptoms, including diarrhea, nausea, vomiting, mouth 

sores, upset stomach, abdominal pain, and constipation. Talk with your 

healthcare provider about ways to handle these problems. 

• rash or other skin changes, including drier, thicker, or cracking skin. 

• blisters or a rash on the palms of your hands and soles of your feet. 

• taste changes 

• loss of appetite 

• pain or swelling in your arms or legs 

• cough 

• shortness of breath 

• bleeding, such as nosebleeds or bleeding from cuts. 

Call your healthcare provider if you have any swelling or bleeding during 

treatment with SUTENT. 

These are not all the possible side effects of SUTENT. For more information, 

ask your healthcare provider or pharmacist. Call your doctor for medical 

advice about side effects. You may report side effects to FDA at 1-800-FDA- 

1088. 

How do I store SUTENT 

• Store SUTENT at room temperature, between 59°F to 86°F (15°C to 30°C). 

Keep SUTENT and all medicines out of the reach of children. 

General information about SUTENT 

Medicines are sometimes prescribed for purposes other than those listed in 

a Medication Guide. Do not use SUTENT for a condition for which it was not 

prescribed. Do not give SUTENT to other people, even if they have the same 

symptoms you have. It may harm them. 

This Medication Guide gives the most important information about SUTENT. 

For more information about SUTENT, talk with your healthcare provider or 

pharmacist. You can ask your healthcare provider or pharmacist for information 

about SUTENT that is written for health professionals. 

For more information go to www.SUTENT.com or call 1-877-5-SUTENT. 

What are the ingredients in SUTENT 

Active ingredient: sunitinib malate 

Inactive ingredients: mannitol, croscarmellose sodium, povidone (K-25), 

magnesium stearate Orange gelatin capsule shell: titanium dioxide, red iron 

oxide Caramel gelatin capsule shell: titanium dioxide, red iron oxide, yellow 

iron oxide, black iron oxide White printing ink: shellac, propylene glycol, 

sodium hydroxide, povidone, titanium dioxide 

This Medication Guide has been approved by the U.S. Food and Drug 

Administration. 

Gleevec ® is a registered trademark of Novartis Pharmaceuticals Corp 

LAB-0361-5.0 

April 2012 

Distributed by 

Pfizer Labs 

Division of Pfizer Inc, NY, NY 10017

Amgen, Inc. 

34 

www.amgen.com 

Oncology-related products: Aranesp ® (darbepoetin alfa), Epogen ® 

(epoetin alfa), Neulasta ® (pegfilgrastim), Neupogen ® (filgrastim), 

Nplate ® (romiplostim), Prolia ® (denosumab), Sensipar ® (cinacalcet), 

Vectibix ® , (panitumumab), Xgeva (denosumab) 

Patient and Reimbursement 

Assistance Website 

www.amgenassistonline.com 

Patient Assistance 

Commercial Co-Pay Assistance 

Coupon Support 

Amgen offers co-pay coupon programs 

for Neulasta ® , Nplate ® , and Xgeva 

to help eligible patients who are commercially 

insured with their deductible, 

co-insurance, and/or co-payment requirements. 

To confirm your eligibility and 

enroll in one of these programs, please 

call 1.888.65.STEP1 (888.657.8371) or 

visit www.amgenfirststep.com. 

Co-Pay Support 

Patients who are commercially and government 

insured (including Medicare), 

but need financial assistance, can be 

referred to independent non-profit co-pay 

foundations. Amgen makes donations to 

these foundations that, in turn, help qualifying 

insured patients with out-of-pocket 

costs, including co-payments and premiums, 

to cover the medicines they need. 

●● 

●● 

●● 

HealthWell ® Foundation 

(www.healthwellfoundation.org) 

Patient Advocate Foundation 

(www.patientadvocate.org) 

Patient Access Network 

(www.panfoundation.org) 

Uninsured Patients 

The Safety Net Foundation is a non-profit 

patient assistance program that helps 

qualifying uninsured patients access 

Amgen medicines at no cost. Patients 

may be able to receive Amgen medications 

at no cost from The Safety Net 

Foundation if they meet the following 

eligibility requirements: 

●● 

Are a resident of the US or its 

territories 

●● 

●● 

●● 

Satisfy income eligibility requirements 

Have no or limited drug coverage 

Do not have any other insurance 

options. Note: Qualifying Medicare 

Part D patients may also be eligible. 

To enroll in The Safety Net Foundation, 

patients must complete the Patient Application 

Form in English (www.safetynetfoundation.com/pdf/SNF_Patient_Application_08012012_v3_FINAL.pdf) 

or 

Spanish (www.safetynetfoundation.com/ 

pdf/SNF_Patient_Application_Spanish_08012012_v1_FINAL.pdf) 

and meet 

program eligibility requirements. For 

prospective model products, the patient 

can apply directly to the Foundation. Providers 

do not need to be enrolled in the 

Foundation for prospective products. 

Take this online course and learn about 

the insurance process from two perspectives 

as an advocate at a non-profit 

foundation and a practice manager in a 

cancer program share their combined 

knowledge about: 

■■ 

■■ 

■■ 

The Medicare and Medicaid 

programs, MAC carriers, and the 

Part D drug benefit, including 

the “donut” hole and its effect on 

patients. 

The prescription drug benefits 

of private payers, such as drug 

formularies and drug tiers. 

Benefit verification, secondary 

benefits, prior authorizations, 

re-authorizations, and more. 

For drug replacement, the provider 

must apply to the Foundation on the 

patient’s behalf. The provider must first 

enroll in the Foundation before they can 

enroll a patient. Download the Facility 

Application form in English (www. 

safetynetfoundation.com/pdf/SNF_Facility_Application_08012012_v2_FINAL. 

pdf ) or Spanish (www.safetynetfoundation.com/pdf/SNF_Patient_Application_Spanish_08012012_v1_FINAL.pdf. 

Once enrolled, providers can complete 

the Product Replacement Request Form 

(www.safetynetfoundation.com/pdf/ 

SNF_Product_Replacement_Request_ 

Form_08012012_v2_FINAL.pdf). 

Institutions that have enrolled as Individual 

Patient Assistance Program (IPAP) 

facilities may use the IPAP Patient Application 

to enroll their patients. The form is 

available in both English (www.safetynetfoundation.com/pdf/SNF_IPAP_Patient_ 

Application_08012012_v2_FINAL.pdf) 

and Spanish (www.safetynetfoundation. 

com/pdf/SNF_IPAP_Patient_Application_08012012_v2_FINAL.pdf). 

Questions Call 1.888.762.6436. 

REIMBURSEMENT ASSISTANCE 

Amgen Assist ® Online 

Amgen Assist Online gives patients and 

healthcare providers a single destination 

for access to online services and forms, 

and makes it easier to find a program that 

would best meet each patient’s unique 

needs. 

Understanding the Insurance Process 

■■ 

■■ 

■■ 

How to estimate the patient’s 

responsibility, including co-pays 

and deductibles. 

The appeals process. 

Disability, including eligibility, 

the application process, and 

coverage. 

Register at: www.accc-cancer.org/ 

education/FinancialCounseling- 

Courses.asp. This course is part 

of ACCC’s Financial Information 

and Learning Network educational 

program. 

 


Pennrose – St. Francis Health 

Services, Colorado 

●● 

●● 

●● 

●● 

Insurance verification 

Prior authorization 

Billing and claims processing support 

and tracking 

Policy and program updates. 

Online tools include: 

●● 

Benefit verification forms 

●● 

Patient consent forms 

●● 

Sample letters of appeal 

●● 

Sample letters of medical necessity. 

Register today at: www.amgenassistonline.com/Registration/Registration. 

aspx. You can also call Amgen Assist 

at 1.888.4ASSIST and speak with an 

Amgen Reimbursement Counselor 

specific to your region for support with 

reimbursement or patient assistance. 

You can contact Amgen Assist by 

phone to request insurance verifications 

regarding Amgen products and for 

reimbursement and assistance information. 

Available Monday–Friday, 9 am– 

8 pm EST. After-hours calls are returned 

within one business day. 

Amgen Reimbursement Counselors 

You will be assigned a dedicated Amgen 

Reimbursement Counselor—a single 

point of contact with regional expertise 

responsible for coordinating all reimbursement 

activity for providers and 

patients. Your Amgen Reimbursement 

Counselor will assist you with: 

●● 

●● 

Comprehensive insurance 

verifications 

Prior authorization support, when 

●● 

●● 

●● 

●● 

●● 

●● 

required by the insurance company 

Billing and claims processing support 

Claims review and tracking, when 

requested to assist status and payment 

tracking 

Appeals process research and status 

tracking, when prior authorizations or 

claims are denied 

General payer policy research 

Initiating recertification for patients 

continuing on therapy 

Identifying patient financial assistance 

programs, for those patients 

requiring financial assistance. 

In addition, Amgen Reimbursement 

Counselors will be available upon request 

by providers to assist patients with 

counseling to understand their insurance 

benefits and referrals to financial 

assistance programs. 

Billing and Claims Processing 

Support 

Amgen has more than 20 years of experience 

addressing coverage, coding, and 

payment issues regarding its products. 

Our reimbursement experts can provide 

timely answers to billing questions about 

Medicare, Medicaid, commercial 

insurers, and managed care. 

Appeals Support 

If an insurance claim is denied or underpaid, 

or if a prior authorization request is 

denied, our staff can work with insurers 

to help resolve the issues. We can also 

help physicians and patients understand 

the payer and plan appeals process. Your 

Amgen Reimbursement Counselor can: 

●● 

Research a plan’s appeal requirements 

and procedures 

●● 

Discuss the requirements and answer 

your questions to facilitate the 

appeals process 

●● 

●● 

Provide letters of medical necessity 

forms to help streamline the process 

Track the appeal status with the payer 

and provide updates and results. 

Insurance Verification 

You can now initiate insurance verification 

requests online, as well as track 

service requests and outcomes on a 

patient-specific level. You can also 

contact Amgen Assist by phone to 

request insurance verifications regarding 

Amgen products. Amgen Assist will 

help you: 

●● 

●● 

Verify patients’ benefits and identify 

insurer coverage guidelines 

Obtain prior authorization (PA) 

when needed. Amgen Assist staff 

will quickly research the patient’s 

PA requirements to help you obtain 

authorization before treatment. 

Prior Authorization 

Amgen Assist can: 

●● 

Verify patients’ benefits and coverage 

for Amgen products 

●● 

Assist with submitting PA requests 

●● 

Follow up with providers to ensure 

form requirements are met 

●● 

Work with Amgen to resolve payer 

issues. 

35 


ARIAD Pharmaceuticals, Inc. 

www.ariad.com 

Oncology-related products: Iclusig (ponatinib) 



www.ariadpass.com 


ARIAD PASS 

ARIAD is pleased to introduce the 

ARIAD Patient Access & Support 

Services (ARIAD PASS) program to 

help providers and their patients access, 

afford, and adhere to treatment. At 

ARIAD PASS benefit coordinators are 

available to help providers and their 

ARIAD 

PA S S 

Patient Access & 

Support Services 

ICLUSIG 

patients with ASSURANCE 

patient assistance (free 

product) and co-pay assistance programs. 

ARIAD PPASS Aalso offers S dedicated 

oncology-certified nurses to 

S 

assist patients ICLUSIG with treatment support, 

disease education, QUICKSTART 

and referrals to other 

assistance programs, upon request. The 

ARIAD PASS Pbenefits A coordinator S S 

provides eligible patients with an array of 

financial assistance ICLUSIG options, including copay 

or coinsurance COPAY support based on their 

insurance coverage and financial need. 

To enroll Pyour Apatient Sin this Sprogram, 

download the ARIAD PASS Enrollment 

Form at: www.ariadpass.com/ARIAD_ 

PASS_Enrollment_Form.pdf. Completed 

forms should be faxed to: 1.855.557. 

PASS (1.855.557.7277). Questions Call 

1.855.447.PASS (1.855.447.7277) Monday 

through Friday, 7:00 am-7:00 pm CST. 


ARIAD PASS 

ARIAD PASS offers coverage and 

reimbursement support to providers 

and patients. To ensure that patients can 

promptly begin therapy, a benefits coordinator 

can help providers determine: 

●● 

A patient’s level of insurance 

coverage 

●● 

Additional requirements, such as 

prior authorizations 

●● 

Any preferred specialty pharmacy. 

To enroll your patient in this program, 

download the ARIAD PASS Enrollment 

Form at: www.ariadpass.com/ARIAD_ 

PASS_Enrollment_Form.pdf. Completed 

forms should be faxed to: 1.855.557. 

PASS (1.855.557.7277). Questions Call 

1.855.447.PASS (1.855.447.7277) Monday 

through Friday, 7:00 am-7:00 pm CST. 

36 

Palo Alto Medical Foundation, 

California 

 


Astellas Pharma US, Inc. 

www.us.astellas.com 

Oncology-related products: Tarceva ® (erlotinib) tablets (co-marketed 

with Genentech, Inc.), Xtandi ® (enzalutamide) capsules 



www.astellasaccess.com 


Xtandi Access Services 

This program helps guide providers and 

patients, from understanding patient 

cost-sharing obligations to addressing 

financial barriers to Xtandi. Cost-sharing 

is expected to be similar for Xtandi as for 

other oral anti-cancer agents. 

Xtandi Access Services can determine 

whether a patient is eligible for one 

of several avenues of assistance available 

to patients who may not be able to afford 

their cost-sharing obligations. There are 

three ways in which patients may be 

able to obtain assistance with accessing 

Xtandi: 

1. Patients with private insurance may 

be eligible to participate in the Xtandi 

Patient Savings Program. 

2. Medicare patients may be referred to 

independent co-pay foundations. 

3. Uninsured patients may be eligible for 

the Astellas Access Program. 

Need help determining which type of 

patient assistance a patient qualifies 

for Take the online Patient Assistance 

Eligibility Questionnaire at: www.astellasaccess.com/home/hcp/xtandi/patient_ 

assistance/eligibility_questions.aspx or 

call Xtandi Access Services directly to 

discuss available assistance options at: 

1.855.8XTANDI (1.855.898.2634). 

Xtandi Patient Savings Program 

This program is for patients who have 

commercial and/or private health insurance 

but who may have trouble paying 

their out-of-pocket costs. Patients may 

expect to pay no more than $20 outof-pocket 

per drug fill. The program 

will cover the remaining cost-sharing 

obligation up to $1,500 per month and 

up to $12,000 in prescription costs per 

calendar year. Note: income eligibility 

rules apply and void where prohibited by 

law. The program is not valid for patients 

who have coverage under Medicare 

(including Medicare Part D), Medicaid, 

Medicare Advantage, TRICARE, 

CHAMPUS, Puerto Rico government 

health insurance, or any other federal– or 

state-funded pharmaceutical benefit program. 

Contact Xtandi Access Services at 

1.855.8XTANDI (1.855.898.2634) or your 

preferred specialty pharmacy to determine 

whether a patient is eligible for enrollment 

in the program or to learn more. 

Astellas Access Program 

This program is designed for patients 

who have no health insurance. It provides 

free Xtandi to patients who qualify 

for enrollment based on insurance and 

household income status. Patients may be 

eligible for the Astellas Access Program 

if they meet all of the following criteria: 

●● 

●● 

●● 

●● 

Have been prescribed Xtandi for an 

FDA-approved indication or an authorized 

compendia listing 

Are uninsured or awaiting determination 

from public assistance (such as 

Medicaid) 

Satisfy the income criteria 

Have a verifiable shipping address 

within the United States. 

To enroll a patient, providers must 

complete and submit 

a request with a 

valid prescription. 

The quickest way to 

apply for assistance 

is via Astellas Access 

eService at: www. 

astellasaccess.com/ 

home/hcp/xtandi/ 

reimbursement_services/eservice_portal. 

aspx. Providers can 

also submit a request 

by completing the 

Patient Enrollment 

Form (www. 

astellasaccess.com/ 

Docs/XTANDI/ 

XAS_Patient_Enrollment_Form.pdf) 

Sanford Cancer Center, 

South Dakota 

and faxing it to 1.855.982.6341. When 

applying, providers must retain one of 

the following as proof of income for your 

patient: 

●● 

Copy of the patient’s most recent tax 

return 

●● 

Copy of the patient’s most recent W-2 

form 

●● 

Copy of the patient’s 1099 Social 

Security form 

●● 

Copy of the patient’s most recent 

Social Security benefit letter 

●● 

Copy of the patient’s latest pay stub 

for a consecutive 30 days. 

Once the patient is approved for assistance, 

we will notify both the prescriber 

and patient that they have been enrolled. 

An initial 30-day supply of Xtandi is 

then shipped directly to the patient’s 

home. Subsequent 30-day refills are then 

sent automatically to the patient’s home 

throughout the approval period. Patients 

may be approved for assistance with 

Xtandi for up to one year. The Astellas 

Access Program will contact patients and 

their healthcare providers 45 days before 

the approval period is scheduled to end to 

discuss re-enrollment needs. Healthcare 

providers can then re-apply on behalf of 

their patients. 


Xtandi Access Services 

The program offers an array of resources 

to help facilitate product coverage and 

payment, including: 

●● 

Answering questions about 

37 


Xtandi Access Services Model 

Submit Patient Enrollment Form to either Xtandi Access Services or 

a specialty pharmacy within our preferred network. 

Xtandi Access 

Services 

Specialists 

Verify patient coverage for Xtandi. 

Assist with prior authorization, if required. 

Address financial barriers for patients through the Astellas Access 

Program, the Xtandi Patient Savings Program, or referrals to independent, 

not-for-profit foundations. 

Xtandi Access 

Services 

Specialists 

Specialty 

Pharmacy 

Patients receive Xtandi from the specialty pharmacy or 

in-office pharmacy. 

38 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

reimbursement, coverage, and payment 

for Xtandi 

Verifying patient insurance coverage 

and cost-sharing 

Helping verify insurance requirements 

and track prior authorizations 

Providing assistance when prior authorizations 

are denied or when a patient’s 

insurer does not cover Xtandi 

Helping coordinate with a specialty 

pharmacy within our network that is 

contracted with your patients’ insurers 

to dispense Xtandi 

Determining whether patients are 

eligible for financial assistance for 

out-of-pocket costs associated with 

Xtandi 

Providing 24/7 access to status 

updates on requests for patient 

assistance via our eService at: www. 

astellasaccess.com 

Directing patients to additional information 

about Xtandi treatment. 

To enroll your patient in Xtandi Access 

Services, complete the Patient Enrollment 

Form at: www.astellasaccess.com/ 

Docs/XTANDI/XAS_Patient_Enrollment_Form.pdf 

in its entirety (required 

fields marked with an asterisk), including 

the signatures section, and return via 

fax to 1.855.982.6341. The completed 

signature section allows Xtandi Access 

Services to: 

●● 

Perform the necessary service(s) to 

assist with patient access to Xtandi 

●● 

●● 

Astellas Access Program for 

Xtandi 

Log onto Astellas eService at: www.astellasaccess.com/home/hcp/ 

xtandi/reimbursement_services/eservice_portal.aspx. 

Select “Initiate Access Application” and provide required information. 

Requests must be submitted by the prescribing physician or 

authorized facility employee. 

Retain copies of patient’s proof of income. 

If the patient meets eligibility criteria, he or she will be enrolled into 

the program. Both the patient and provider will receive notification 

of enrollment. 

Patients will receive their Xtandi shipment within 2 to 5 business 

day of approval notification. 

Triage the completed prescription(s) 

to a specialty pharmacy in the Xtandi 

Access Services network 

View patient’s Personal Health 

Information, including a patient’s 

financial information to determine 

the most appropriate form of financial 

assistance as appropriate. 

 


Bayer HealthCare 

Pharmaceuticals, Inc. 

www.pharma.bayer.com 

Oncology-related product: Nexavar ® (sorafenib) tablets (co-marketed 

with Onyx Pharmaceuticals), Stivarga ® (regorafenib) tablets, Xofigo ® 

(radium Ra 223 dichloride injection) 

Patient Assistance and 

Reimbursement Website 

www.nexavar-us.com 

www.stivarga-us.com/hcp/ 

gist/support.html 

PATIENT ASSISTANCE 

REACH ® – Commercial Co-pay 


Patients with private insurance may 

be eligible to receive co-pay assistance 

through REACH (Resources for Expert 

Assistance and Care Helpline). This program 

is designed to reduce the monthly 

co-pay of patients with private insurance. 

Patients covered by Medicare are 

not eligible for this program. A REACH 

counselor can tell you if your patient is 

eligible for co-pay assistance. If eligible, 

co-pays range from $0 to a maximum 

of $100 per prescription. REACH works 

directly with the specialty pharmacy 

and no special cards or coupons will be 

necessary. To enroll your patient, call 

1.866.639.2827 to speak with a REACH 

counselor. Enrollment forms are also 

available online: 

●● 

●● 

English: www.nexavar-us.com/html/ 

pdf/consumer/English_REACH_ 

form.pdf 

Spanish: www.nexavar-us.com/html/ 

pdf/consumer/Spanish_REACH_ 

form.pdf. 

Note: REACH is not for patients receiving 

prescription reimbursement under 

Florida Hospital, Waterman 

Cancer Institute, Florida 

any federal-, state-, or governmentfunded 

insurance programs or where 

prohibited by law. 

The REACH Program for Stivarga 

and Nexavar 

The REACH support program provides 

a single point of contact for healthcare 

professionals prescribing Stivarga or 

Nexavar and their patients. REACH first 

works with providers, their staff, and the 

specialty-pharmacy network to coordinate 

the prescription-filling and reimbursement 

process. REACH will then work directly 

with patients receiving therapy to provide 

ongoing support. To enable a patient to 

obtain Stivarga or Nexavar: 

1. Fill out the REACH enrollment 

forms, including writing the prescription 

on the form. Download the form 

at: www.stivarga-us.com/downloads/ 

reach_enrollment_ form.pdf 

2. Sign the form in the space provided 

under “Physician Declaration” 

3. Have your patient sign the form in 

the space provided under “Patient 

Authorization” 

4. Fax both pages of the form to: 

1.866.639.5181. 

REACH counselors will then evaluate 

your patient’s coverage and provide a 

summary of benefits and in-network 

SPP options to you and your patient. For 

more information, contact REACH at 

1.866.639.2827. 

REACH Counselors can help patients 

identify other sources to help get their 

prescriptions, including: 

●● 

●● 

●● 

●● 

Broad insurance plan coverage for 

Nexavar and Stivarga. A REACH 

counselor can contact your insurance 

company to help determine coverage 

for your therapy. 

Medicare Part D plans cover 

these therapies. A REACH counselor 

can help determine coverage. 

The patient assistance program 

provides eligible patients with a 

30-day supply of drug shipped to their 

home. Patients approved for the program 

will receive assistance for one 

year, after which they must reapply. 

Temporary patient assistance 

programs offer financial help so 

patients may pay for Nexavar or 

Stivarga while waiting for insurance 

approval. In addition, a REACH 

counselor can contact the insurance 

39 


Xofigo Access Services ® 

This program offers comprehensive 

support for Xofigo patients, either 

through finding coverage sources, helping 

eligible uninsured and underinsured 

patients through drug assistance 

programs, or assisting eligible insured 

patients with their co-share obligations. 

Patient assistance. Xofigo Access 

Services provides Xofigo free of charge 

for eligible patients who are uninsured 

or who are insured but do not have 

coverage for Xofigo. To qualify for 

assistance, patients must meet certain 

eligibility criteria, including: financial 

criteria based on adjusted gross household 

income; residency in the U.S., 

including the District of Columbia, 

Puerto Rico, Guam, or the U.S. Virgin 

Islands; and treatment provided in an 

outpatient setting. Providers must apply 

for assistance on behalf of their patients 

by submitting a completed application. 

Call 1.855.696.3446 to obtain more 

information and request an application. 

Co-pay assistance. Patients with 

private commercial insurance may 

be eligible for co-pay or coinsurance 

assistance for Xofigo if they 

meet eligibility criteria, including: 

financial criteria based on adjusted 

gross household income; residency 

in the U.S., including the District of 

Columbia, Puerto Rico, Guam, or the 

U.S. Virgin Islands; and treatment 

provided in an outpatient setting. 

Providers must apply for assistance 

on behalf of their patients by submitting 

a completed application. Co-pay 

assistance funds are sent directly 

to the provider. Access Counselors 

can provide information and support 

through the application process. Call 

1.855.696.3446 to obtain more information 

and request an application. 

Patients with public insurance, such 

as Medicare or other government payers, 

are not eligible for co-pay assistance 

through the Xofigo Commercial 

Co-pay Assistance Program. Access 

Counselors can provide information 

about independent co-pay assistance 

foundations that may be able to help 

these patients. 

Alternate funding sources. Access 

Counselors can research potential 

alternate sources of funding, such 

as Medicaid or other state and local 

assistance programs. If your patient 

is eligible for one of these programs, 

an Access Counselor can provide 

information about the program and 

how to apply. 

Insurance benefits. Xofigo Access 

Services can providers research insurance 

benefits and confirm coverage for 

treatment with Xofigo. If the patient’s 

insurance does not cover treatment with 

Xofigo, Access Counselors can help 

research alternate sources of funding 

for treatment. 

For more information about Xofigo 

Access Services, call 1.855.6XOFIGO 

(1.855.696.3446), Monday through 

Friday, 9:00 am to 8:00 pm EST, or go 

online to www.xofigo-us.com. 

40 

●● 

●● 

company to help with the approval 

process. Note: this program is not 

for patients receiving prescription 

reimbursement under any federal-, 

state-, or government-funded insurance 

programs or where prohibited 

by law. 

State pharmaceutical assistance 

programs provide prescription coverage 

and payment assistance for the 

disabled and low-income seniors that 

qualify. REACH counselors can find 

out information about this program in 

the patient’s state. 

Other sources of assistance include 

referrals to charitable foundations or 

support groups that can assist with 

your co-pay or other related medical 

expenses. Ask a REACH counselor to 

help identify these resources. 

REACH Education & Support 

Materials for Nexavar 

The REACH program provides patients 

with the materials they will need 

throughout their treatment with Nexavar. 

Once patients join the REACH program, 

they will receive the following materials: 

✔✔ 

Your Guide to Nexavar brochure— 

everything patients need to know 

about Nexavar, including: 

■■ 

■■ 

■■ 

Getting the most out of their 

therapy 

Proactively handling potential side 

effects 

Important items to discuss 

with their doctor and insurance 

provider 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

■■ 

■■ 

■■ 

■■ 

Weekly treatment tracker 

Reminder stickers 

Dosing reminder card 

Helpful resources and tips for 

patients and caregivers, such as 

finding strength and staying active 

Pillbox 

Coupons 

Udder smooth cream 

Dermal therapy lotion 

Prescribing Information. 

Patients can also expect a call from a 

REACH oncology nurse to help answer 

any questions they may have about 

their Nexavar therapy. In addition, 

REACH counselors are available to 

provide you with the support you need: 

1.866.639.2827. Enroll online today at 

www.nexavar-us.com/scripts/pages/en/ 

patient/patient-support/support-materials/enroll-in-reach. 

REACH Education & Support 

Materials for Stivarga 

Once Stivarga has been prescribed, 

patients will get a Starter Kit with these 

materials: 

✔✔ 

✔✔ 

The Stivarga Brochure (www. 

stivarga-us.com/downloads/Stivarga_Brochure.pdf) 

provides an 

overview of what Stivarga is, how it 

can help, and what to expect during 

treatment 

The Stivarga Treatment Journal 

(www.stivarga-us.com/downloads/ 

Stivarga_Patient_Treatment_Journal.pdf) 

helps patients keep track 

✔✔ 

✔✔ 

of taking their Stivarga tablets and 

record their general health 

Lotion and therapeutic socks for 

hand-foot skin reaction (HFSR) 

Lotion coupon to help with ordering 

and purchasing more lotion. 


A REACH counselor can help patients 

understand their insurance options and 

get the best coverage possible. Simply 

call 1.866.639.2827 and a specially 

trained REACH counselor will: 

●● 

Communicate with insurance companies 

and help patients obtain coverage 

for Nexavar or Stivarga—from obtaining 

authorization of coverage to following 

through if coverage is denied 

●● 

●● 

●● 

Help to determine if patients qualify 

for various financial assistance programs 

and assist with the application 

process 

Identify a specialty pharmacy provider 

(SPP) that will fill the prescription and 

send it directly to patient’s home. 

Enrollment forms are available at: 

English: www.nexavar-us.com/html/ 

pdf/consumer/English_REACH_ 

form.pdf 

●● 

Spanish: www.nexavar-us.com/html/ 

pdf/consumer/Spanish_REACH_ 

form.pdf. 

Enrollment forms can also be obtained 

by calling 1.866.639.2827, Monday 

through Friday, 9:00 am to 8:00 pm EST. 

 


Boehringer Ingelheim 


http://us.boehringer-ingelheim.com 

Building on scientific expertise and 

excellence in the fields of pulmonary 

and cardiovascular medicine, metabolic 

disease, neurology, virology, and 

immunology, Boehringer Ingelheim has 

embarked on a major research program 

to develop innovative cancer treatments. 

Working in close collaboration with the 

international scientific community and 

a number of the world’s leading cancer 

centers, Boehringer Ingelheim’s commitment 

to oncology is underpinned by 

using advances in science to develop a 

range of targeted therapies for various 

solid tumors and hematological cancers. 

The current focus of late-stage research 

includes compounds in three areas: 

1. Signal transduction inhibition 

2. Angiogenesis inhibition 

3. Cell-cycle kinase inhibition. 

If you or someone you know is interested 

in participating in a Boehringer 

Ingelheim clinical trial, please visit 

www.bicancertrials.com. If you are a 

healthcare provider and are interested in 

learning more about BI clinical trials in 

oncology, please visit www.inoncologyus. 

com for additional information. 

Afatinib Expanded Access Program 

(EAP) 

Boehringer Ingelheim’s expanded 

access program for its investigational, 

oncology compound, afatinib, is for 

eligible U.S. patients with locally 

advanced or metastatic non-small 

cell lung cancer (NSCLC) who have 

an epidermal growth factor receptor 

(EGFR) mutation. (Note: afatinib is 

an investigational agent. Its safety and 

efficacy have not been established.) 

Afatinib is an investigational therapy 

and has not been approved by the U.S. 

Food and Drug Administration (FDA). 

The afatinib EAP (clinical trial identifier 

NCT01649284) is an open-label, U.S. 

multi-center trial for patients with locally 

advanced or metastatic NSCLC who have 

an EGFR mutation. Patients not previously 

treated with an EGFR-targeted therapy, as 

well as those previously treated with these 

agents, may be eligible for the afatinib 

EAP. As a single-arm trial, afatinib will 

not be compared to another anti-cancer 

therapy. Enrollment criteria are available 

on www.clinicaltrials.gov and include 

patients with: 

●● 

Locally advanced or metastatic 

NSCLC 

●● 

Positive test for EGFR mutation(s) 

●● 

Performance status between 0 and 2. 

Healthcare professionals and patients can 

learn more about the afatinib EAP by 

calling 1.855.EAP.BIPI (855.327.2474) or 

by visiting www.clinicaltrials.gov. 

Exempla Saint Joseph Comprehensive 

Cancer Center, Colorado 

41 


Bristol-Myers Squibb 

42 

Assistance for Uninsured Patients 

For patients without prescription drug 

insurance, Access Support can refer them 

to independent charitable foundations 

that may be able to provide financial support, 

including, the Bristol-Myers Squibb 

Patient Assistance Foundation, a charitable 

organization that provides mediwww.bms.com 

Oncology-related products: Erbitux ® (cetuximab), Ixempra ® 

(ixabepilone), Sprycel ® (dasatinib), Yervoy ® (ipilimumab) 



www.bmsaccesssupport.com 


Access Support 

Access Support offers patient assistance 

support, benefits investigation, prior 

authorization support, and appeals assistance. 

Program counselors are available 

Monday through Friday, from 8:00 am to 

8:00 pm EST at 1.800.861.0048. Access 

Support can help identify financial assistance 

programs for patients who need 

help managing the cost of treatment. The 

appropriate program will depend on the 

patient’s coverage: 

●● 

For patients with commercial 

insurance, product-specific co-pay 

programs may be available 

●● 

●● 

For patients with federally-funded 

insurance, co-pay support from independent 

foundations may be available 

For patients with no insurance, product 

donations from the BMS Patient 

Assistance Program may be available. 

BMS Oncology Co-Pay Program for 

Yervoy 

This program is designed to assist with 

out-of-pocket co-payment 

or co-insurance 

requirements for eligible, 

commercially 

insured patients 

who have been 

prescribed certain 

BMS products, per 

the FDA-approved 

indications. Patients 

with federally-funded 

insurance plans are 

not eligible for this 

co-pay program. 

Enrolled patients pay 

the first $50 of their 

co-pay per infusion. 

BMS will cover the remaining amount 

up to $5,000 per year. If patient out-ofpocket 

expenses exceed $5,000 per year, 

the patient is responsible for 5% of the 

remaining out-of-pocket expenses. BMS 

will then pay 95% of the remaining outof-pocket 

expenses. BMS will contribute 

a maximum of $25,000 per year, per 

patient. Patient must have an annual 

household income of less than or equal 

to $100,000 to qualify for the program. 

Other restrictions may apply. Final determination 

of program eligibility is based 

upon review of completed application. 

In order to enroll a patient in the BMS 

Oncology Co-Pay Program, the following 

information is required: 

●● 

●● 

●● 

●● 

●● 

Name 

Address 

Insurance carrier 

Member ID 

Your office identification number. 

To enroll a patient, complete the application 

form (www.bmsaccesssupport.com/ 

PublishingImages/YERVOY-Enrollment- 

Form.pdf) and fax it to Access Support at 

1.888.776.2370. 

Southern Ohio 

Medical Center 

Cancer Services, 

Ohio 

cine, free of charge, to eligible, uninsured 

patients who have an established financial 

hardship. The Bristol-Myers Squibb 

Patient Assistance Foundation accepts 

the Access Support application. Patients 

may be eligible for assistance through the 

Bristol-Myers Squibb Patient Assistance 

Foundation if they: 

●● 

●● 

●● 

●● 

●● 

●● 

Do not have public or private 

insurance that helps to pay for their 

prescription medications. If the 

patient is enrolled in Medicare Part 

D, call the Bristol-Myers Squibb 

Patient Assistance Foundation, Inc. 

for more information. The number is 

1.800.736.0003. 

Have a yearly income of less than 

~250% of the Federal Poverty Level: 

✔ ✔ $27,925 or less for a single person 

✔ ✔ $37,825 or less for a family size 

of two 

✔✔ 

Larger family sizes are adjusted 

accordingly 

✔✔ 

Medications that are injected may 

be subject to higher limits. 

Are being treated with Bristol-Myers 

Squibb medications. 

Live in the United States, Puerto 

Rico, or the US Virgin Islands. 

Are being treated by a doctor or other 

healthcare provider who is licensed 

in the US. 

Are being treated as an outpatient. 

These are just some of the eligibility 

requirements. Other eligibility criteria 

may apply. For more information 

about eligibility, call the Bristol-Myers 

Squibb Patient Assistance Foundation, 

at 1.800.736.0003. To enroll a patient, 

complete the appropriate application 

form below and fax it to Access Support 

at 1.888.776.2370. 

●● 

●● 

●● 

●● 

Erbitux: www.bmsaccesssupport. 

com/PublishingImages/ERBITUX- 

Enrollment-Form.pdf 

Ixempra: www.bmsaccesssupport. 

com/PublishingImages/IXEMPRA- 


Sprycel: www.bmsaccesssupport. 

com/docs/SPRYCEL-Enrollment- 

Form.pdf 

Yervoy: www.bmsaccesssupport.com/ 

PublishingImages/YERVOY-Enrollment-Form.pdf 

Assistance for Patients with 

Federally-Funded Insurance Plans 

Patients with federally-funded insur- 

 


BMS Prior Authorization Algorithm 

STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6 

Step 1: 

Verify Patient 

Coverage. Is your 

patient insured 

Yes. No. 

Step 2: 

Benefits Investigation. 

Step 3: 

Is Prior Authorization 

Required 

Yes. No. 

If prior authorization 

is not needed, 

click next to 

continue. 

Step 4: 

Was Prior 

Authorization 

Received 

Yes. No. 

Step 5: 

You Now 

Have Payer 

Authorization. 

Step 6: 

Claim Approved 

and Patient 

Received 

Medication. 

Yes. No. 

ance plans are not eligible for co-pay 

assistance programs sponsored by 

Bristol-Myers Squibb. However, there are 

independent foundations that can help. 

Access Support can refer providers to 

the foundation offering the best support 

for their specific patient and help them 

through the application process. 

It is important to note that these foundations 

are independent and not affiliated 

with Bristol-Myers Squibb. Each foundation 

has its own eligibility criteria and 

evaluation process. Bristol-Myers Squibb 

cannot guarantee that a patient will 

receive assistance. 

Reimbursement Assistance 

Access Support: Benefits 

Investigation 

Bristol-Myers Squibb Oncology is committed 

to helping appropriate patients 

get access to our medications by providing 

reimbursement support services 

for healthcare professionals. After a 

treatment decision has been made by 

a healthcare professional, work with 

Access Support as early as possible, so 

each case can be tracked through all 

required steps for coverage and your 

eligible patients can benefit from all 

programs we have available. Our Access 

Support counselors are assigned to 

specific geographies to enable continuity 

of support and deeper understanding 

of the local environment. Each time you 

call, you will speak to a specialist who is 

familiar with your office, the details of 

your patients’ cases, and the insurers in 

your area. 

With signed authorization from a 

patient, Access Support can investigate 

the patient’s coverage and benefits for 

Bristol-Myers Squibb products under 

federally-funded health plans. Access 

Support can also help identify potential 

or additional sources of coverage, such 

as Medicaid, Veterans’ Affairs, or Low 

Income Subsidy for Medicare Part D 

enrollees. 

To initiate the benefits investigation 

process, access the appropriate 

enrollment form below. Type in your 

information and save it to your desktop. 

Once the form is completed, fax it to: 

1.888.776.2370 and confirm receipt of the 

fax by calling: 1.800.861.0048. 

●● 

●● 

●● 

●● 

Erbitux: www.bmsaccesssupport. 

com/PublishingImages/ERBITUX- 


Ixempra: www.bmsaccesssupport. 

com/PublishingImages/IXEMPRA- 


Sprycel: www.bmsaccesssupport. 

com/docs/SPRYCEL-Enrollment- 

Form.pdf 

Yervoy: www.bmsaccesssupport.com/ 

PublishingImages/YERVOY-Enrollment-Form.pdf. 

Access Support: Prior Authorization 


Access Support can help physicians 

obtain a prior authorization form when 

one is required by the patient’s health 

plan. See the algorithm above to see an 

example process flow that serves as an 

aid to understanding the reimbursement 

and appeals processes. To receive prior 

authorization assistance from Access 

Support you will need: 

●● 

●● 

●● 

●● 

●● 

Patient demographics 

Complete insurance information and 

copy of card 

Physician demographics and signature 

Diagnosis 

Drug. 

Access Support: Appeals Assistance 

Access Support can assist in navigating 

the appeals process. However, the preparation 

and submission of documents to 

support the appeal is the responsibility of 

the patient and/or healthcare provider. Providers 

and patients can appeal an insurer’s 

decision to deny coverage for an item or 

service. Some claims may be denied coverage 

due to the evolving nature of many 

drug therapies. Use the information below 

as a reminder when filing an appeal: 

1. Coverage decisions may be made 

by an insurer before the treatment 

is rendered or after a claim is filed. 

Coverage decisions that are made 

before a treatment regimen is initiated 

are often referred to as “prior 

authorizations” or “coverage determinations.” 

2. Medicare Part B and many other 

health insurers will not make a coverage 

decision regarding individual 

patients before a claim is filed; coverage 

is considered only at the time a 

claim is presented for payment. 

3. The billing provider can usually 

appeal an insurer’s decision to deny 

coverage for a claim. Appeals are 

almost always subject to timeliness 

requirements; the window of time 

allowed for a provider to appeal an 

unfavorable coverage decision usually 

begins on the date a claim was adjudicated 

(processed) by the insurer. 

4. If the health insurer approves an 

appeal, you will be notified and the 

claim will be reconsidered. 

If the health insurer denies the appeal, 

contact Access Support for further assistance 

at the Support Center by going to: 

www.bmsaccesssupport.com and clicking 

on the “Support Center” tab. 

43 


Celgene Oncology 

44 

www.celgene.com 

Oncology-related products: Abraxane ® for Injectable Suspension 

(paclitaxel protein-bound particles for injectable suspension), 

Istodax ® (romidepsin) for Injection, Revlimid ® (lenalidomide), 

Thalomid ® (thalidomide), Vidaza ® (azacitidine) 



www.celgenepatientsupport. 

com 


Celgene Free Medication Program 

Patients who cannot pay for a Celgene 

medication that their doctor prescribed 

may be eligible for this program. 

Patients must meet financial criteria to 

be eligible for assistance. Eligibility is 

based on household income and assets, as 

described below: 

Income 

●● 

Salary/wages 

●● 

Pension 

●● 

Social Security 

●● 

Disability 

●● 

Earnings from dividends 

●● 

Earnings from rental property. 

Assets 

Savings, checking, money market 

accounts 

CDs 

Estimated market value of IRAs 

Estimated market value of stocks, 

mutual funds 

Estimated market value of bonds. 

●● 

●● 

●● 

●● 

●● 

Note: Assets do not include: household 

items, personal property, house, or car. 

To determine a patient’s eligibility, 

contact Celgene Patient Support at: 

1.800.931.8691 or email: patientsupport@celgene.com. 

Depending on the 

type of help needed, the Celgene Patient 

Support Specialist may ask patients to 

complete the following forms: 

●● 

Patient Assistance Application 

(www.celgenepatientsupport.com/ 

pdf/PAA-form.pdf). The application 

has two parts: one for the provider to 

●● 

●● 

complete, and one for the patient to 

complete. 

Appointment of Representative 

Release Form (www.celgenepatientsupport.com/pdf/AORR-form.pdf). 

This form is needed so that Celgene 

may help with appeals upon a denial 

from an insurance company. By 

completing this form, patients are 

allowing Celgene Patient Support to 

call their insurance company and ask 

questions on the patients’ behalf. 

Medicare Low-Income Subsidy 

(“Extra Help”) Form (https://secure. 

ssa.gov/i1020/start).The low-income 

subsidy provides extra help in paying 

for prescription drug costs. 

Co-pay Assistance Programs 

Even if patients have insurance, they still 

may not be able to pay for their medication. 

There are programs and foundations 

that may help patients pay for 

co-payments and out-of-pocket expenses. 

A Celgene Patient Support Specialist 

will guide providers and patients through 

the available resources. Contact Celgene 

Celgene Patient 

Support Checklist 

Your Celgene Patient Support 

Specialist may need the following 

information so they can assist you. 

Have this information available 

when you call. 

Patient Information 

●● 

Name 

●● 

Social Security Number 

●● 

Date of Birth 

●● 

Address 

●● 

Phone Number 

●● 

Medical Insurance Card(s) 

●● 

Prescription Drug Card(s) 

Patient Medical Information 

Medication 

Diagnosis 

Physician’s Name 

Physician’s Phone Number 

●● 

●● 

●● 

●● 

Patient Support at: 1.800.931.8691 or 

email: patientsupport@celgene.com. 

These professionals can: 

●● 

●● 

●● 

●● 

●● 

Connect patients with organization(s) 

that may provide financial assistance. 

Guide patients through filling out 

the forms. (Note these professionals 

cannot complete the paperwork for 

patients.) 

Let the provider’s office know about 

options available to patients. 

Regularly follow up with patients 

and providers about applications for 

assistance. 

Let the provider’s office know about 

the final resolution. 

Remember that each organization has 

their own rules for helping patients. 

Celgene Patient Support cannot influence 

decisions by organizations on providing 

assistance. The Celgene Patient Support 

Specialist may need certain information 

to help providers and patients. Download 

the Celgene Support Checklist at: www. 

celgenepatientsupport.com/pdf/CPSchecklist.pdf. 


Celgene Patient Support 

Celgene Patient Support helps providers 

and patients navigate the challenges of 

reimbursement, providing information 

about co-pay assistance, and answering 

questions about obtaining Celgene products. 

Celgene Patient Support Specialists 

work with providers and patients to: 

●● 

Explain benefits 

●● 

Facilitate prior authorization 

●● 

Assist with appeal support after insurance 

denials 

●● 

Navigate your Medicare coverage 

●● 

Assess co-pay options 

●● 

Follow up on prescription status 

●● 

Help apply for the Celgene free medication 

program 

●● 

Offer guidance through Celgene 

products and restricted distribution 

programs. 

For more help, contact Celgene Patient 

Support at 1.800.931.8691. Your Celgene 

Patient Support Specialist is a dedicated, 

central point of contact who will work 

to coordinate resources available to 

providers and patients. Together, we will 

exhaust all options to help providers and 

patients get the information they need. 

 


Eisai Co., Ltd. 

www.eisai.com 

Oncology-related products: Aloxi ® 

(palonosetron hydrochloride), 

Dacogen ® (decitabine) for 

Injection, Fragmin (dalteparin 

sodium injection), Gliadel ® 

(polifeprosan 20 with carmustine 

implant) Wafer, Halaven 

(eribulin mesylate), Hexalen ® 

(altretamine) Capsules, Ontak ® 

(denileukin diftitox), Targretin ® 

(bexarotene) capsules, Targretin ® 

(bexarotene) gel 1% 

Sample Letter of Appeal for Aloxi 

Date 

Name of Health Insurance Company 

PO Box or Street Address 

City, State, Zip Code 

Appeal (or Request for Reconsideration): Aloxi ® (palonosetron HCl) injection – J2469 

Beneficiary: Patient Name 

HIC Number or Member Number 

Dates of Service: [mm-dd-yy through mm-dd-yy] 

Claim Number(s): [List each ICN claim number for each date of service denied] 


Assistance Website: 

www.eisaireimbursement.com 


The Eisai Assistance Program 

The Eisai Patient Assistance Program 

provides Eisai medicines at no cost to 

financially needy patients who meet 

program eligibility criteria. To prescreen 

your patients for eligibility go to: 

www.eisaipatientassistance.com. This 

prescreening tool is intended to assist 

healthcare professionals in: 

●● 

Determining if a patient may be 

eligible for the patient assistance 

program 

●● 

Pre-populating enrollment forms to 

be submitted for the patient assistance 

program. 

The prescreening process is an initial 

step to determine if a patient may be 

eligible. A final enrollment determination 

will be made once a complete and 

signed enrollment form and prescription 

are submitted via fax to: 1.866.57EISAI 

(1.866.5734724). Other online tools 

include: 

●● 

The Eisai Patient Assistance 

Program Enrollment Form (www. 

eisaireimbursement.com/Aloxi/ 

downloads/Eisai_Oncology_PAP_ 

App_ALv_010411_pg2_writable.pdf). 

The same form is used for all Eisai 

drugs. 

●● 

To Whom It May Concern: 

The above claims were denied as not medically necessary and not covered under 

Medicare Part B. We are requesting a re-determination of the denial of coverage for 

Aloxi (palonosetron HCl) injection 0.25 mg. Aloxi is indicated for the prevention of 

acute nausea and vomiting associated with initial and repeat courses of moderately 

and highly emetogenic cancer chemotherapy, as well as the prevention of delayed 

nausea and vomiting associated with initial and repeat courses of moderately emetogenic 

cancer chemotherapy. 

[In the second paragraph, outline the patient’s history, diagnosis, and chemotherapy 

treatment. Provide rationale for Aloxi treatment.] 

In light of the above, I believe Aloxi should be covered by Medicare for this patient. 

Use of Aloxi was medically necessary, and it was an appropriate drug for my patient 

at the time to prevent [state complication]. Relevant documentation is enclosed with 

this request for re-determination. Also enclosed are copies of claims submitted for 

payment and explanation(s) of Medicare benefits received showing the reason for the 

original determination(s). 

Respectfully submitted, 

[Physician Name, Signature] 

Enclosures: 

Explanation of Medicare benefits 

Copies of claim forms submitted (CMS-1500 or CMS-1450) 

Copies of patient medical records 


Insurance Verification Form (www. 

eisaireimbursement.com/Aloxi/ 

downloads/Eisai_Oncology_IV_ 

Form_113010.pdf). The same form is 

used for all Eisai drugs. 

This program can help qualified 

indigent, underinsured, and uninsured 

patients obtain medication and find 

alternative sources of coverage. To 

learn more about the Eisai Assistance 

Program and gain access to our team of 

dedicated reimbursement consultants, 

call 1.866.61.EISAI (1.866.613.4724). 

Reimbursement consultants are available 

Monday through Friday, from 

8:00 am to 8:00 pm EST. 

45 


The Michael and Dianne Bienes Comprehensive 

Cancer Center at Holy Cross Hospital, Florida 

46 



The Eisai Assistance Program helps 

providers minimize payer access and 

coverage challenges. The program is the 

first-line resource for information relating 

to your patients’ insurance coverage. 

What to expect when you contact the 

Eisai Assistance Program: 

●● 

●● 

Product-specific reimbursement 

information 

Understanding of coverage, coding, 

and payment issues 

●● 

●● 

●● 

●● 

Insurance verification processing 

Prior authorization assistance 

General guidance for appealing a 

denied claim 

Payer policy information. 

Online Tools 

The Eisai Assistance Program offers 

providers a wide range of online tools 

for each of its products, including: 

●● 

●● 

●● 

●● 

Product information 

Billing forms 

ICD-9-CM diagnosis codes 

ICD-9-CM supplementary 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

classification codes 

CPT drug administration codes 

HCPCS Level II codes 

National drug codes 

Revenue codes 

Medicare reimbursement rates 

A checklist for claims submission 

Sample appeal letters (see box, 

page 45) 

Sample letters of medical necessity 

Coverage policies for physician 

offices, hospital outpatient 

departments, and ambulatory 

surgical centers. 

 


Eli Lilly and Company 

www.lilly.com 

Oncology-related products: Alimta ® (pemetrexed), Erbitux ® 

(cetuximab) co-marketed with Bristol-Myers Squibb, Gemzar ® 

(gemcitabine hydrochloride) 



www.lillytruassist.com 

www.lillypatientone.com 


Lilly TruAssist 

Lilly TruAssist (www.lillytruassist.com) 

is the collection of Lilly patient assistance 

programs that offer assistance to help 

people obtain the Lilly medicines they 

need. This site includes all of Lilly’s 

patient assistance programs with individual 

program details. Finding programs 

that offer Lilly medicines for free is easy 

with the Program Finder Tool: www. 

lillytruassist.com/pages/FindProgram. 

aspx. The tool finder allows patients 

and providers to search for an appropriate 

program one product at a time. Just 

answer a few questions to see which 

program may be right for your patient. 

PatientOne 

PatientOne (www.lillypatientone.com) is 

the program that addresses financial and 

coverage issues for qualified uninsured, 

underinsured, and insured patients 

who are prescribed a Lilly Oncology 

product. Patients are encouraged to 

contact their healthcare professional for 

information regarding support for a Lilly 

Oncology product. 


PatientOne can help provide replacement 

vials for ongoing therapy for qualified 

uninsured patients earning up to 500% 

of the federal poverty level who are 

prescribed a Lilly Oncology product. 

Federal poverty level depends on family 

size. Patients must meet basic points of 

eligibility: 

✔✔ 

✔✔ 

Patient has no medical insurance or 

his or her insurance does not cover 

therapy 

A qualified Lilly Oncology drug will 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

be administered in the U.S. 

Patient is in ongoing therapy 

Proof of residency in the United 

States or Puerto Rico 

Patient meets the financial guidelines 

for the program 

The date of service must be within 

180 days from the date PatientOne 

receives the application 

Treatment is or will be provided in 

an outpatient setting (provider is 

community-based billing on CMS- 

1500 or outpatient-facility billing 

on UB-04). 

If patients meet these eligibility 

requirements, download the enrollment 

application (www.lillypatientone. 

com/Documents/application.pdf ) and 

dosage tracking form (www.lillypatientone.com/Documents/pdf/dosage_ 

tracking_ form.pdf). Providers can also 

call 1.866.4PatOne (1.866.472.8663) 

to receive enrollment forms. Fax completed 

application and proof of income 

to 1.888.242.6230. Patient’s eligibility 

is confirmed within two business 

days. PatientOne will also determine if 

there are alternate methods of coverage 

available to the patient, including 

Medicaid, VA, other payers, state 

pharmacy assistance programs, or 

charitable foundations. If patients apply 

for Medicaid, Medicare, VA, or other 

coverage, they may be temporarily 

approved for the Lilly Patient Assistance 

Program. Eligible patients will 

be enrolled into the Patient Assistance 

Program. Approved dates of 

service will be determined based on 

the submitted Dosage Tracking Form. 

Replacement vials for ongoing therapy 

will be sent to the provider’s office. 

Note: This is not a replacement program—it 

is only for ongoing therapy. 

Underinsured Patients 

Co-pays and deductibles can often be 

financial distractions. PatientOne provides 

assistance in identifying programs 

that can help qualified patients who are 

prescribed a Lilly Oncology product 

cover these expenses. PatientOne can: 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

Learn about the patient’s needs and 

assess our ability to help 

Provide information on co-pay assistance 

programs 

Transfer to a specific foundation upon 

request 

Conduct a complete benefits investigation 

for eligible Lilly Oncology 

products. 

The PatientOne Hotline accepts calls 

from and provides support for: 

Patients 

Caregivers 

Physicians 

Administrators 

Cancer practice professionals. 

●● 

●● 

●● 

●● 

●● 

Call 1.866.4PatOne (1.866.472.8663) 

Monday through Friday, 9:00 am to 7:00 

pm EST and select option 1. 

If the patient meets basic points of eligibility, 

complete and fax a Patient Assistance 

Program Application Form (www. 

lillypatientone.com/Documents/application.pdf) 

and Certification of Brand Drug 

Usage Form (www.lillypatientone.com/ 

Documents/pdf/gc67769_certification_ 

of _brand_drug_usage_ form_ fa.pdf) if 

applicable to: 888.242.6230. The treating 

physician will receive a written response 

from PatientOne, regarding eligibility 

for drug replacement. We will review the 

patient’s eligibility for the Patient Assistance 

Program based on the submitted 

application. If the patient meets eligibility 

requirements, replacement vials will be 

sent to the provider’s office for ongoing 

therapy. 

Insured Patients 

When an insurance claim is denied 

for patients receiving an eligible Lilly 

Oncology product, PatientOne can 

provide assistance with the claim appeal 

process. PatientOne can conduct a complete 

benefits investigation for applications 

with an approved diagnosis for 

eligible Lilly Oncology products at no 

cost to patients. Healthcare professionals 

may contact us at 1.866.4PatOne to 

request that a Reimbursement Assistance 

Application Form be faxed to you, 

or download and fill out the Reimbursement 

Assistance Application Form at: 

www.lillypatientone.com/Documents/ 

pdf/AppealsandReimbursementAssistanceApplication.pdf. 

Fax completed 

form and Certification of Brand Drug 

47 


48 

Usage Form 9 (www.lillypatientone. 

com/Documents/pdf/gc67769_certification_of 

_brand_drug_usage_ form_ 

fa.pdf) if applicable to: 888.242.6230. 

The treating physician will receive 

a written response from PatientOne, 

Take this online course and learn how 

to deliver financial assistance in a 

thoughtful and sensitive manner, as 

well as strategies to help patients maintain 

control of their finances so they 

can better focus energies on treatment 

and recovery. 

An experienced oncology social 

worker provides strategies and tips 

about: 

■■ 

■■ 

■■ 

■■ 

Patient Counseling 101 

Communicating with empathy 

The basics of customer service 

Patient and family assessments 

and interventions 

Non-compliance assessment and 

regarding eligibility for drug replacement. 

We also provide templates, forms, 

and checklists that may assist you in 

filing an appeal for denied claims for 

eligible Lilly Oncology products. 

Upon request we can contact the 

■■ 

Spartanburg Regional Medical Center, 

The Marsha and Jimmy Gibbs Regional 

Cancer Center, South Carolina 

interventions 

Situational case studies of “hard 

to handle” situations. 

Register at: www.accc-cancer.org/education/FinancialCounseling-Courses. 

asp. This course is part of ACCC’s 

Financial Information and Learning 

Network educational program. 

insurance provider to determine the 

status of your appeal submission and 

can notify you of the insurance provider’s 

decisions. If the appeals process 

does not result in a favorable decision, 

after two levels of appeal have been 

completed or all appeals have been 

exhausted, we will review the patient’s 

eligibility for the Patient Assistance 

Program based on the submitted Application. 

If the patient meets eligibility 

requirements, replacement vials will be 

sent to the provider’s office for ongoing 

therapy. 


Lilly PatientOne Reimbursement 

Services 

Eli Lilly and Company recognizes that 

medical insurance issues for oncology 

patients may be numerous and often 

complex. Lilly PatientOne provides 

medical professionals, on behalf of their 

patients, with access to current reimbursement 

information and support programs. 

The resources provided here are 

designed to assist providers with some 

of the complex issues associated with 

securing health insurance reimbursement 

for their oncology patients. The 

purpose of this information is to help 

ensure accurate coverage, coding, and 

allowable payments for Lilly’s Oncology 

products. Tools offered include: 

●● 

A denied claims checklist: www. 

lillypatientone.com/Documents/ 

MG73325.Checklist.pdf 

●● 

●● 

●● 

●● 

Attestation statement: www. 

lillypatientone.com/Documents/ 

MG63241.L.Attestation.Statement. 

Legal.pdf 

Letter of Medical Necessity information: 

www.lillypatientone.com/ 

Documents/MG73487.L.6_LOMN. 

Guide.pdf 

First and second level appeal letter for 

commercial and third-party payers: 

www.lillypatientone.com/Pages/reimbursement.aspx 

First and second level Medicare 

Review letters: www.lillypatientone. 

com/Pages/reimbursement.aspx. 

If you have any questions about the 

program, please call us at 1.866.4PatOne 

(1.866.472.8663) Monday through Friday, 

9:00 am-7:00 pm EST. 

 


EMD Serono 

www.emdserono.com 

EMD Serono is the biopharmaceutical 

division of Merck KGaA, Darmstadt, 

Germany, a global pharmaceutical and 

chemical group. EMD Serono is growing 

its presence in oncology in the U.S, with 

a focus on developing novel first-in-class 

therapies targeting the cancer disease 

process. Their oncology research and 

development focuses on three areas: 

●● 

●● 

●● 

The tumor cell 

The tumor environment 

The immune system. 

EMD Serono supports a variety of patient 

and reimbursement assistance programs, 

including: 

MS Lifelines ® (www.mslifelines.com) 

services include: 

●● 

Reimbursement Specialists. The 

knowledgeable and dedicated team 

of Reimbursement Specialists helps 

patients understand their health 

insurance coverage and options, and 

may also discuss available assistance 

programs, including programs offered 

by MS LifeLines. 

●● 

●● 

●● 

Nurse Support. The MS LifeLines 

Nurse Network provides education, 

training, and support for people with 

relapsing MS. 

Peer Support. MS LifeLines 

Ambassadors are people living with 

relapsing MS who want to share 

their experiences, and can offer hope 

and encouragement to patients and 

families. 

Telephone Support. MS Lifelines 

provides 24/7 telephone support. 

Call 1.877.447.3243 to speak with a 

live representative at any time, day 

or night. 

Fertility Lifelines 

(www.fertilitylifelines.com) 

Fertility LifeLines is staffed with highly 

trained customer service representatives, 

infertility nurses, and benefits specialists 

ready to assist callers with: 

●● 

●● 

●● 

●● 

●● 

General infertility information 

Insurance benefit verification 

Find a fertility specialist tool 

EMD Serono product support 

Emotional support through compassionate 

listening to help put the 

patient journey into perspective and 

provide information about additional 

support and resources. 

Call 1.866.LETSTRY(1.866.538.7879) 

Monday through Friday, 9:00 am– 

5:30 pm EST. 

Florida Hospital, Waterman 

Cancer Institute, Florida 

49 


Genentech, Inc. 

www.gene.com 

Oncology-related products: Avastin ® (bevacizmuab), 

Erivedge (vismodegib), Herceptin ® (trastuzumab), Perjeta 

(pertuzumab), Rituxan ® (rituximab), Tarceva ® (erlotinib), 

Xeloda ® (capecitabine), Zelboraf ® (vemurafenib) 



www.genentech-access.com 


Genentech Access Solutions: 

The Genentech Access to Care 

Foundation ® 

The Genentech Access to Care Foundation 

(GATCF) was created to help 

patients who are uninsured—or who 

have been denied coverage by their 

health plans. GATCF might be able to 

help those patients receive treatment if 

they meet specific financial and medical 

criteria. For your patient to be eligible 

for help from GATCF, certain specific 

criteria must be met: 

●● 

●● 

●● 

Your patient must have no health 

insurance or the health plan has 

denied coverage 

Your patient’s annual household 

adjusted gross income must be 

$100,000 or less (special consideration 

may be given to patients with 

unique circumstances) 

Your patient must meet medical 

criteria determined by the GATCF 

Clinical Advisory Board. 

To determine if your patient qualifies, 

request a GATCF Eligibility Screening 

when you conduct the initial benefits 

investigation. To apply to GATCF, providers 

must: 

✔✔ 

✔✔ 

✔✔ 

Complete and submit the Statement 

of Medical Necessity form: www. 

genentech-access.com/sites/default/ 

files/product-documents/avastin/ 

Healthcare%20Professionals/Statement-of-Medical-Necessity_1.pdf 

Have the patient complete and submit 

a Patient Authorization and Notice of 

Release of Information form: www. 

genentech-access.com/sites/default/ 

files/product-documents/avastin/ 

Healthcare%20Professionals/Patient- 

Authorization-and-Notification_1.pdf 

Submit the forms online via My 

Patient Solutions (www.mypatientsolutions.com) 

or fax completed forms 

to: 888.249.4919. 

Once we receive your patient’s information, 

GATCF will contact the patient 

within 24 hours with further instructions. 

50 

Mary Bird Perkins Cancer Center, Louisiana 

 


This may include verifying financial 

eligibility. Note: GATCF has the right to 

modify or end this program at any time 

and to verify the accuracy of the information 

you submit. 

Additional GATCF Program details: 

●● 

●● 

●● 

Patients are eligible for free medicine 

for one year; patients must reapply 

annually 

Patient assistance support may be 

given before treatment or up to one 

year post-treatment 

GATCF assists with the cost of drug 

only, not the administration costs. 

If you have concerns about your 

patient’s insurance coverage for drugs, 

ask for a GATCF Eligibility Screening 

at the time you submit the Statement of 

Medical Necessity. We can then assess 

whether a patient’s medical condition 

and self-reported income meet GATCF 

criteria. If the patient’s insurer denies 

coverage after treatment begins, your 

patient could be eligible for free drugs 

through GATCF. To start the GATCF 

Eligibility Screening, check the appropriate 

box under Services Requested 

on the Statement of Medical Necessity 

form. Your patient must also certify 

that his or her household adjusted gross 

income is $100,000 per year or less on 

the Patient Authorization and Notice of 

Release Information form. 

A GATCF Eligibility Screening 

approval letter does not guarantee 

acceptance into GATCF. It only states 

that your patient appears to meet the 

GATCF medical and financial criteria 

based on a review of the documents. 

GATCF still needs to confirm the 

complete lack of insurance coverage 

for Genentech products. This includes 

exhausting the appeals process. 

GATCF also needs to verify the medical 

and financial qualifications based 

on the documentation supplied by your 

patient. 

Within 24 hours of receiving completed 

Statement of Medical Necessity 

and Patient Authorization and Notice 

of Release Information forms, Access 

Solutions will fax a letter to the provider. 

A GATCF Eligibility Screening outcome 

notification will follow. 

Questions Call Access Solutions 

Support Line at: 888. 249.4918. Calls are 

taken 6:00 am-5:00 pm PST, Monday 

through Friday. 

GATCF Extension Program for 

Medicare Part D 

Administered through GATCF, the 

GATCF Extension for Medicare Part D 

program provides Erivedge, Tarceva, or 

Zelboraf at no cost to financially eligible 

patients who have a Medicare Part D plan 

and who do not qualify for co-pay assistance 

from a co-pay assistance foundation. 

Please note: Patients must meet the 

GATCF medical and financial criteria. 

Genentech BioOncology Co-pay 

Card 

Genentech offers the Genentech 

BioOncology Co-pay Card to help 

qualified patients with the out-of-pocket 

costs associated with their prescription. 

Eligible patients must be 18 years of 

age or older and covered by commercial 

insurance (non-governmental). Patients 

are considered not eligible if they are: 

●● 

●● 

●● 

Participating in Medicare, Medicaid, 

Medigap, VA, DoD, or TRICARE 

(or any other federal- or state-funded 

benefit programs, including government 

employee programs) 

Uninsured (refer to Genentech Access 

to Care Foundation or currently 

participating in GATCF) 

Currently residing or receiving services 

in Massachusetts or Vermont. 

Eligible patients are responsible for 20 

percent of the out-of-pocket costs for 

their Genentech cancer therapy. They 

may have access to up to $4,000 over 

one year to help with their co-pay. 

Patients who make a household income 

greater than $100,000 per year have a 

yearly limit of $1,500. Patients only need 

to provide a verbal statement to verify 

their income when they enroll. Proof 

of documentation at a later date may 

be required. Call 855.MYCOPAY (855. 

692.6729) to confirm patient eligibility 

and activate the card. 

Referrals to Co-pay Assistance 

Foundations 

If your patients need help with their 

medication co-pays, Access Solutions 

can connect them to co-pay assistance 

foundations supporting their disease 

state. Genentech does not influence or 

control the operations of these co-pay 

assistance foundations, but Access Solutions 

can assist patients in navigating the 

process of seeking co-pay assistance by 

making an appropriate referral based on 

a patient’s diagnosis and by assisting with 

the application process. We cannot guarantee 

co-pay assistance once a patient has 

been referred by Access Solutions. The 

foundations to which we refer patients 

each have their own criteria for patient 

eligibility, including financial eligibility. 

How it works: 

1. Patient or caregiver contacts Access 

Solutions and expresses concerns 

about his or her co-pay. 

2. An Access Solutions specialist will: 

■■ 

■■ 

■■ 

■■ 

Connect the patient to a co-pay 

assistance foundation with available 

funding 

Support patients throughout the 

enrollment process, answering any 

questions they might have as they 

fill out the application 

Notifiy the provider of the 

patient’s referral to a co-pay assistance 

foundation 

Reach out to patients to check on 

the process. 

3. Once the patient informs us that he 

or she has been approved, the Access 

Solutions specialist informs the physician 

of the results via fax. 

Key points to remember about 

co-pay assistance foundations: 

●● 

For some foundations, approval can 

occur in less than 30 days with possible 

contingent approval sooner 

●● 

●● 

●● 

●● 

●● 

If the patient is denied assistance 

by one foundation, he or she can be 

referred to a different foundation, if 

one is available 

Although each foundation offers 

some form of assistance, it might not 

be a full award 

The application process might require 

some form of financial verification 

All aspects of application processing 

can vary by foundation and are 

determined by each foundation 

Patients should be sure to submit the 

application and required documentation 

in a timely manner to avoid 

delays or gaps in coverage. 

Avastin Patient Assistance Program 

The Avastin Patient Assistance Program 

was developed in response to concerns 

about increased costs associated with the 

higher doses of the new indications the 

FDA approved in 2006. By limiting the 

51 


52 

overall annual cost of Avastin, the program 

can help oncologists and patients 

pursue clinically appropriate on-label 

treatment without concern about additional 

costs. How the program works: 

●● 

●● 

●● 

The program provides an opportunity 

for physicians and eligible patients 

who reach an annual dosage of 

10,000 mg to receive free Avastin 

from Genentech for the remainder of 

the 12-month period. 

Participation in the program is voluntary. 

The treating oncologist identifies 

eligible patients for enrollment in the 

program. 

The treatment year for each patient is 

measured independently and begins 

with the patient’s first infusion. 

●● 

At the end of the patient’s first 12 

●● 

months of therapy, the patient and/or 

payer resumes financial responsibility 

until the 10,000 mg limit is reached in 

the next 12 months. 

Patients are eligible to receive free 

Avastin only if they are treated by 

the same provider throughout the 

period when the 10,000 mg of Avastin 

accrues. Patients who change providers 

while receiving free Avastin under 

the program will be eligible only if 

the new location is within the original 

provider’s organization. 


Access Solutions Benefits 

Investigation 

Access Solutions conducts a Benefits 

Investigation to help you better understand 

your patient’s health plan coverage 

for some or all of the costs associated 

with treatment. The investigation can 

also determine if a prior authorization or 

patient assistance might be needed. To 

have Access Solutions conduct an investigation, 

request our assistance on the 

signed Statement of Medical Necessity 

form. There are three possible outcomes 

of a benefits investigation: 

●● 

●● 

●● 

Treatment is covered 

Prior authorization is required 

Treatment is denied. 

To begin with Access Solutions, you 

must complete and submit the Statement 

of Medical Necessity (www.genentechaccess.com/sites/default/files/productdocuments/avastin/Healthcare%20 

Professionals/Statement-of-Medical- 

Necessity_1.pdf) and have your patient 

complete and submit a Patient Authorization 

and Notice of Release of Information 

form (www.genentech-access.com/sites/ 

default/files/product-documents/avastin/ 

Healthcare%20Professionals/Patient- 

Authorization-and-Notification_1.pdf). 

Submit the forms online via My 

Patient Solutions (www.mypatientsolutions.com) 

or fax completed forms to: 

888.249.4919. Patients can submit the 

Patient Authorization and Notice of 

Release of Information form online at: 

https://pan.iassist.com/forms/bioonc. 

Access Solutions Prior Authorization 


Access Solutions can help providers 

identify whether a prior authorization is 

needed and help them in the process of 

securing it. All we need to begin are a 

completed and signed Statement of Medical 

Necessity form requesting our assistance 

with the prior authorization, as well 

as a signed and dated Patient Authorization 

and Notice of Release of Information 

form. Access Solutions can help providers 

as they submit the required forms and 

documentation. If the prior authorization 

is not granted, Access Solutions can work 

with providers to determine the next steps. 

Access Solutions Appeals 

If your program has prescribed a Genentech 

product, but your patient’s insurer 

has denied coverage, you can appeal that 

decision. Access Solutions might be able 

to help providers as they resolve the situation. 

Here is what providers can do: 

1. Understand why the request or claim 

has been denied. This should be in 

the insurer’s letter of denial or the 

patient’s Explanation of Benefits 

(EOB) letter 

2. Contact Access Solutions for guidance 

as they put together an appeal. 

Use these resources to help them 

gather the documents and information 

they need for a successful appeal 

3. Complete and submit the required 

forms and documents to the insurer 

before the appeal deadline. Access 

Solutions can provide information 

about this process. 

Questions Call 866.4ACCESS (866. 

422.2377) 6:00 am-5:00 pm PST, Monday 

through Friday. 

My Patient Solutions 

My Patient Solutions (www.mypatientsolutions.com) 

connects your program 

with our program. We’re available 

online to help providers with access and 

reimbursement whenever a Genentech 

medicine is prescribed. It’s the most efficient 

way to work with Access Solutions 

to get patients on therapy as soon as possible. 

Features of My Patient Solutions: 

●● 

●● 

●● 

●● 

●● 

●● 

Online enrollment. Prescriber 

electronic signatures and scanned 

document attachments allow for a 

completely paperless patient enrollment 

process. 

Benefits investigation reports. Your 

patients’ full benefits investigation 

reports are uploaded to My Patient 

Solutions in real time so you can 

know exactly what is covered before 

beginning treatment. 

Search your patient cases. Search 

for patient cases initiated via fax or 

through My Patient Solutions for 

easier patient case management. 

Genentech Access to Care Foundation 

refill requests. Request refills for 

GATCF prescriptions online via My 

Patient Solutions to avoid interruption 

in therapy. 

Alerts. Get alerts (e.g., Statement 

of Medical Necessity expiring in 

30 days) to learn what actions you 

should take to connect your patients 

to their medicine. You can opt 

to receive these alerts via email 

as well. 

Information you need to register 

your practice. You will need the 

following information in order to 

successfully register your practice: 

1. Primary Genentech products 

prescribed by your practice 

2. User information including email 

addresses (you may add additional 

users at a later date) 

3. Practice location information (you 

may add additional locations at a 

later date) 

4. Prescriber licensing information, 

including a Prescriber National 

Provider Identifier and State 

license number (required). 

You will be asked to agree to the My 

Patient Solutions Practice Agreement. 

You must agree to these terms to proceed 

with My Patient Solutions. 

 


Genomic Health, Inc. 

www.genomichealth.com 

Oncology-related products: Oncotype DX ® Breast Cancer Assay ® , 

Oncotype DX ® Colon Cancer Assay ® 



www.oncotypedx.com 

authorized healthcare provider. However, 

in the rare cases where all appeals are 

exhausted and the claim is not fully paid, 

the patient will ultimately be responsible 

for any balance remaining on the invoice. 

Genomic Health provides a comprehensive 

financial assistance program for 

patients with financial hardship and a 

program for uninsured and underinsured 

patients based on financial eligibility. 

GAP has been designed to assist 

patients and authorized healthcare providers 

with any billing or reimbursement 

issues related to the Oncotype DX test. 

Genomic Health welcomes questions 

and encourages you to contact GAP 

if you have questions. Call Genomic 

Health Customer Service at: 

866.ONCOTYPE (866.662.6897) 

or visit: www.oncotypedx.com. 


Genomic Health provides a comprehensive 

financial assistance program for 

patients with financial hardship and a 

program for uninsured and underinsured 

patients based on financial eligibility. 

Call Genomic Health Customer Service 

at: 866.ONCOTYPE (866.662.6897) for 

more information. 


Genomic Access Program 

The Genomic Access Program (GAP) 

assists patients throughout the process 

of determining coverage and billing 

insurance. 

Genomic Health is prepared to 

bill insurance plans directly on behalf 

of insured patients in the U.S. whose 

authorized healthcare providers order 

the Oncotype DX test. Many insurance 

plans have established favorable coverage 

policies for the Oncotype DX test for 

node-negative, estrogen-receptor-positive 

breast cancer patients. These insurance 

plans include Medicare, UnitedHealthcare, 

CIGNA, Aetna, Kaiser Permanente, 

Health Net, Humana, Blue Shield of 

California, WellPoint, and many others. 

Through GAP, the patient’s authorized 

healthcare provider can request a 

Benefits Investigation to help determine 

if the Oncotype DX test is covered by the 

patient’s insurance plan. Some insurers 

require a prior authorization before processing 

the patient’s specimen; the GAP 

team can also help facilitate this process. 

If a claim is denied on first review, 

the GAP team can assist in appealing 

this denial, with input from the patient’s 

Cancer Care Northwest, Washington 

Take this online course and learn the 

skills you need to offer financial assistance 

services to patients in an efficient 

and sensitive manner. An experienced 

patient advocate discusses: 

■■ 

■■ 

■■ 

■■ 

Financial Counseling 101 

Service line assessment. What 

financial assistance services does 

your program currently offer 

What services would your program 

like to offer in the future 

Strategies for developing 

and/or growing financial assistance 

services. 

Process mapping. How to flowchart 

your process, including the 

steps and staff members involved 

in providing financial assistance 

services. How to look for ways to 

improve or streamline processes. 

Required job skills for staff 

■■ 

■■ 

delivering financial assistance 

services. 

Position descriptions. 

Performance metrics. How does 

or will your program measure 

how financial assistance services 

affect quality of care, patient and 

provider satisfaction, and more. 





53 


GlaxoSmithKline 

www.gsk.com 

Oncology-related products: Arranon ® (nelarabine), Arzerra ® 

(ofatumuab), Bexxar ® (tositumomab), Hycamtin ® (topotecan) 

capsules, Hycamtin ® (topotecan hydrochloride) for Injection, Leukeran 

(chlorambucil), Myleran ® (busulfan), Promacta ® (eltrombopag), 

Tykerb ® (lapatinib), Votrient (pazopanib) 



www.commitmenttoaccess. 

com 


Commitment to Access Program 

Commitment to Access is GlaxoSmith- 

Kline’s patient assistance program that 

provides GSK oncology and specialty 

pharmacy products—at little or no 

cost—to qualified patients. Patients must 

meet eligibility criteria to qualify for 

assistance. All patients must be enrolled 

through an Advocate (i.e., someone such 

as a healthcare worker, social worker, 

or case worker, who is involved in the 

delivery of the patient’s healthcare). 

■■ 

■■ 

■■ 

3-person household: Total monthly 

income $7,954.17 (48 states, 

DC, and Puerto Rico); $9,945.83 

(Alaska); and $9,150.00 (Hawaii). 


income $9,604.17 (48 states, DC, 

and Puerto Rico); $12,008.33 


For each additional person, add: 

$1,650.00 (48 states, DC, and 

Puerto Rico); $2,062.50 (Alaska); 

and $1,895.83 (Hawaii). 

Proof of income and other requested 

documents must be submitted along with 

the completed and signed application. 

In addition, a prescription with refills, if 

medically appropriate, must be submitted 

for mail-order refills. 

If the applicant filed income tax or 

was listed as a dependent on someone 

else’s income tax for the most recently 

filed tax year, attach a copy of page one 

of the tax form. If no tax was filed or if 

the tax form does not represent current 

income, attach proof of income from all 

sources for the most recent 30-day period 

for the applicant and all members of the 

household. Please provide copies, not 

original documentation, of pay stubs, 

unemployment stubs, Social Security 

statements, pension statements, and any 

other sources of income. The following 

are examples of acceptable proof of 

income. 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

Income tax form. A copy of page 

one of the most recently filed 1040, 

1040A, or 1040EZ. 

Salary and wages. One month consecutive 

salary or wages documentation, 

copy of pay stub with year-todate 

income, letter indicating salary 

and wages on company letterhead, 

notarized statement from employer, or 

bank statement showing salaries and 

wages deposited by employer. 

Self-employment income. 1099 form, 

including Schedule C from the most 

recent tax return. 

Social Security retirement. Benefit 

statement for current year or copy of 

most recent check or check stub. 

Supplemental Security Income. Benefit 

statement for current year or copy 

of most recent check or check stub. 

Social Security Disability. Benefit 

statement for current year or copy of 


Unemployment. Unemployment 

54 

To Qualify for Commitment to Access, 

Patients: 

1. Cannot have prescription drug benefits, 

unless the coverage is limited to 

generic prescription medicine only 

2. Cannot be eligible for Medicaid or 

Puerto Rico Government Health Plan 

(Reforma) 

3. Can be a Medicare Part D participant 

who has spent $600 on prescription 

medicines this year 

4. Must live in one of the 50 states, the 

District of Columbia, or Puerto Rico 

5. Must have gross monthly household 

income at or below the following: 

■■ 

■■ 










to improve your revenue cycle and 

your cancer program’s bottom line. 

An experienced cancer program 

administrator offers strategies to: 

■■ 

■■ 

■■ 

■■ 

■■ 

Evaluating & Improving Your Revenue Cycle 

Improve the coding and billing 

processes. 

Improve efficiency within the 

revenue cycle, including tips for 

submitting clean claims. 

Develop a system to track denials 

and appeals. 

Develop and manage a drug 

replacement program. 

Establish a process for data collection. 

What information needs 

to be collected and how Sample 

spreadsheets to help track information 

related to claims, denials, 

appeals, and more. 





 


Grand View Hospital Cancer Program, Pennsylvania 

●● 

●● 

●● 

●● 

award letter on company letterhead 

indicating amount and time period 

covered or copy of most recent unemployment 

check or check stub. 

Alimony and child support. Court 

award letter indicating amount and 

time period covered, Child Support 

Enforcement Agency letter, letter 

from attorney stating amount and 

time period covered, copy of one 

month’s check, or bank statement 

with the amount indicated. 

Veterans Benefits. Benefit statement 

for current year, copy of most 

recent bank statement showing direct 

deposit, or copy of most recent check 

or check stub. 

Pension and retirement earnings. 

Benefit statement for current year, 

copy of most recent bank statement 

showing direct deposit, or copy of 


Other. Benefits statement, award 

letter, bank statement from payer or 

source, copy of check(s), or judgment 

statement. 

Providers and patients can go online to: 

www.commitmenttoaccess.com/calculator/do-i-qualify.html 

and answer a few 

short questions to find out whether the 

patient may be eligible for Commitment 

to Access or another GSK patient assistance 

program. 

How to Enroll 

There are three steps to enrollment. 

1. Complete and print an online application 

at: www.commitmenttoaccess. 

com/enrollment/phone-application. 

html. Then the Advocate must 

call Commitment to Access at 

1.8ONCOLOGY1 (1.866.265.6491) 

to enroll the patient. Be sure the 

patient signs and dates the “Patient 

Authorization to Release and Disclose 

Medical Information” section. Each 

application has a unique 9-digit 

identification number that serves as 

the patient’s Commitment to Access 

ID number for as long as the patient 

remains in the program. Because the 

application has a unique ID number, it 

may not be photocopied. 

2. Gather income documentation (see 

“Patient Eligibility”). 

3. Select an Advocate. Select someone 

involved in healthcare to enroll the 

patient into Commitment to Access 

by telephone (see “Registering the 

Advocate”). The Advocate and patient 

should review the completed application. 

The Advocate will then call 

1.8ONCOLOGY1 (1.866.265.6491) 

to find out if the patient is eligible to 

receive medicine. If eligible, the first 

fill of medication will automatically 

be sent to the address provided on the 

application. 

Registering the Advocate 

Commitment to Access is a program that 

requires enrollment by a registered Advocate. 

An Advocate is anyone involved in 

the delivery of a patient’s healthcare, such 

as a healthcare provider, social worker, or 

case worker. Specifically, Commitment 

to Access Advocates: 

●● 

Help patients obtain, complete, and 

55 


56 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

sign the enrollment application 

Enroll patients by phone 

Submit documentation once the 

phone enrollment is complete 

Order refills for patients if they 

require assistance 

Look up the patient’s prescription 

number 

Help patients re-enroll after a year, if 

needed 

Inform GSK of any prescription, 

address, or income changes 

Follow up with the patient at intervals 

as needed by the program. 

Advocates must register online at: https:// 

www.commitmenttoaccess.com/users/ 

register.html. 

How to Re-enroll 

Patients need to re-apply to Commitment 

to Access every 12 months. Medicare Part 

D patients must re-apply each calendar 

year. Patients are eligible once they have 

spent $600 on prescription medicines. A 

re-enrollment application will be mailed to 

the Advocate when it is time to re-apply. A 

re-enrollment phone call is not necessary. 

If the re-enrollment form is lost, another 

form can be used, but the Patient Identification 

Number on the new form must be 

crossed out and the actual Patient Identification 

Number must be clearly written. 

Receiving Medication 

All Commitment to Access medicines 

except for Bexxar* are mailed directly to 

the provider or patient, based on program 

guidelines per medication. In order to 

receive medicine by mail, Commitment 

to Access must receive the patient 

application, income documentation, 

and a prescription for GlaxoSmithKline 

medicine. The Advocate must fax the 

prescription (with up to 13 refills if medically 

appropriate) to: 1.800.750.9832. The 

patient ID number, name, and date-ofbirth 

must be included. 

Upon receipt and approval of a 

completed re-enrollment application, 

proof of income, and a valid prescription, 

re-enrollment patients will be authorized 

to receive up to 360 days of additional 

medicine, shipped in 30-day increments. 

*Bexxar distribution is handled 

through the BEXXAR Service Center. 

Advocates enrolling Bexxar patients will 

be advised how to obtain Bexxar at the 

time of enrollment. 

Ordering Refills 

To order refills, call 1.8ONCOLOGY1 

(1.866.265.6491). The Advocate or the 

patient can request refills for oral tablets; 

IV drug refills must be requested by 

the Advocate. Be sure to order refills at 

least two weeks before the patient runs 

out of medicine or 7-10 days before the 

next treatment. Refills will not be sent 

automatically. Refills are sent at no cost 

for up to 12 months after enrollment in 

Commitment to Access. Refills can be 

sent to the provider’s office or directly 

to the patient’s home based on program 

guidelines per medication. 

If re-enrollment patients are determined 

eligible for continued assistance 

through Commitment to Access, the 

first fill will automatically be sent to the 

address provided on the application. The 

patient and the Advocate should continue 

to order refills as needed by calling 

1.8ONCOLOGY1 (1.866.265.6491) at 

least two weeks before the medicine supply 

runs out or 7-10 days before the next 

scheduled treatment. Refills will not be 

sent automatically. 

Patients Taking Arzerra ® 

Patients with prescription drug benefits 

through Medicare Part B or through 

a commercial plan may be eligible for 

Commitment to Access when they have 

a co-payment that exceeds $2,000, 

subject to the criteria listed above. 

Advocates may call 1.8ONCOLOGY1 

(1.866.265.6491) for more information. 

Co-Pay Assistance 

This program is for people who have 

prescription coverage but who need 

extra help paying for their oral medicine. 

Patients may qualify for co-pay 

assistance if they have commercial 

prescription drug coverage and live in 

one of the 50 States or the District of 

Columbia (excluding residents of Massachusetts). 

Patients who: 1) have come to 

the United States seeking healthcare and 

live outside the United States; 2) have 

insurance coverage through a government-funded 

program, such as Medicare 

or Medicaid; and 3) are enrolled in a 

health plan that does not permit members 

to participate in co-pay assistance 

programs are not eligible. 

Patient co-pay amounts are dependent 

on household income. Patients are 

responsible for paying the approved 

co-pay amount for each fill of the qualifying 

GSK medicine as listed below: 

●● 

0% to 250% of FPL, patient pays $25 

●● 

251% to 500% of FPL, patient pays 

$50 

●● 

More than 500% FPL: Not eligible for 

co-pay assistance. 

For updated co-pay information call: 

1.888.663.4752. Applicants with 

co-payments or coinsurance that 

exceeds 50% will be responsible for 

any remaining costs not covered by 

their insurance plan or GSK Co-Pay 

Assistance Program. 


CARES by GSK 

CARES by GSK (www.caresbygsk. 

com) offers a variety of reimbursement 

services, including: 

●● 

Verification of benefits. Reimbursement 

counselors will verify coverage 

for patients with all types of 

insurance, including Medicare, 

Medicaid, private payers, Veterans 

Affairs/VHA, TRICARE, AIDS 

drug assistance programs, children’s 

health insurance programs, state 

elderly drug assistance programs, 

and other state and local payers 

●● 

●● 

●● 

●● 

●● 

●● 

Prior authorization assistance. 

Counselors can help patients 

proactively overcome obstacles to 

accessing treatment by researching 

prior authorization requirements for 

payer-restricted drugs 

Coding and billing assistance. 

Counselors are available to answer 

questions about HCPCS, CPT, and 

ICD-9-CM codes for all applicable 

oncology medications 

Coverage analysis. Counselors can 

research and provide patients with 

detailed coverage information, including 

a co-pay forecast 

Denied and underpaid claims 

assistance. Counselors can research 

denied and underpaid claims to 

confirm that they were processed 

appropriately 

Case management. Counselors 

can research foundations and assess 

eligibility for GSK’s patient assistance 

programs 

Researching specialty pharmacies. 

Counselors will research specialty 

pharmacies that offer low co-pays. 

 


Incyte Corporation 

www.incyte.com 

Oncology-related products: Jakafi ® (ruxolitinib) tablets 

✔✔ 

✔✔ 

The amount of the co-pay, if it is 

known. 

Household income. If the patient has 

a pay stub, tax return, or disability 

form, have it on hand. 



www.incytecares.com 



The IncyteCARES (Connecting to 

Access, Reimbursement, Education and 

Support) patient assistance program helps 

people who don’t have a healthcare plan. 

It can also help people whose plans have 

turned them down for Jakafi treatment. If 

patients qualify, they may be able to get 

Jakafi for free. To qualify for financial 

support through IncyteCARES, patients 

must meet the following criteria: 

●● 

No prescription drug coverage or a 

healthcare plan that has said it won’t 

pay for Jakafi and an appeal was 

turned down 

●● 

●● 

●● 

Earn less than $100,000 per year or 

up to 500% of the FPL, based on 

household size 

Be a U.S. resident 

Use of Jakafi is FDA-approved. 

Call 1.855.4.Jakafi (1.855.452.5234), 

Monday through Friday, 8:00 am 

to 5:00 pm, to learn more about 

IncyteCARE’s patient assistance program. 

Co-pay Assistance 

Patients with private or commercial 

prescription insurance may be eligible to 

receive Jakafi for no more than $50 per 

month, depending upon their income. 

To qualify for co-pay assistance through 

IncyteCARES, patients must meet the 

following criteria: 

●● 

●● 

●● 

●● 

Commercially or privately insured 

Earn less than $100,000 per year or 

up to 500% of the FPL, based on 

household size 


Use of Jakafi is FDA-approved. 

Call 1.855.4.Jakafi (1.855.452.5234), 


PeaceHealth Southwest Regional 

Cancer Center, Vancouver, 

Washington 


IncyteCARE’s co-pay assistance program. 

Referral to an INO 

IncyteCARE may also refer patients with 

Medicare Part D plan or other type of 

insurance to an independent, nonprofit 

organization (INO). The INO can find 

ways to help patients with the co-pay. 

Each INO has its own set of rules. While 

IncyteCARES does not influence or 

control the INOs, it can help patients 

through the process of applying for help 

from an INO. IncyteCARES can also 

refer patients to the INO offering the best 

help for them. IncyteCARES can find out 

if patients qualify for federal help. 

To apply to an INO, patients should 

gather the following information: 

✔✔ 

The medical condition and the drug 

the doctor wants the patient to use, in 

this case Jakafi. 

✔✔ 

✔✔ 

The doctor’s name, address, telephone 

number, and fax number. 

The patient’s healthcare plan information. 

Have the insurance card ready. 

If the patient has more than one 

healthcare plan, have all the information 

ready. 

If IncyteCARES refers a patient to an 

INO, they will need to fill out an application. 

Here are some questions patients 

might want to ask the INO to get started: 

●● 

●● 

●● 

●● 

●● 

How long does the approval process 

take after the application is received 

How will I be told if I am approved 

for or denied help from you 

Will my doctor also be told what you 

decide 

If I am approved, where are the 

payments sent 

For how many months can I expect 

to receive this help 

Each application requires patients to 

verify their financial needs. It can take 

from 2 weeks to 30 days for an INO to 

review your application. If the patient is 

turned down by one INO, IncyteCARES 

can refer the patient to another. However, 

IncyteCARE’s role is limited to making 

referrals for patients. IncyteCARES does 

not control the process. Nor does it control 

the decision the INO might make. 

Patient Education & Support 

IncyteCARE’s patient education and 

support include: 

●● 

●● 

●● 

●● 

Education information to help teach 

patients about MF and Jakafi 

Patient Starter Packet 

IncyteCARE’s Welcome Packet 

Access to trained nurse professionals. 

Visit www.incytecares.com to learn 

more. 


Access & Reimbursement Services 

Incyte provides the following services: 

●● 

Benefit verification 

●● 

Prior authorization 

●● 

Appeal support 

●● 

Jakafi delivery information 

●● 

Co-pay assistance 

●● 

Free medication. 

Call 1.855.4.Jakafi (1.855.452.5234), 



IncyteCARE’s reimbursement services. 

57 


Janssen Biotech 

www.janssenbiotech.com 

Oncology-related products: Doxil ® (doxorubicin HCl liposome 

injection), Procrit ® (epoetin alfa), Zytiga ® (abiraterone acetate) 



www.janssenaccessone.com 


access2wellness ® 

If a patient does not have coverage for 

Doxil, Procrit, or Zytiga, this program 

can be the gateway to assistance for eligible 

patients that meet specific medical 

and financial criteria. Reach an access- 

2wellness specialist at: 866.317.2775, 

Monday through Friday, 9:00 am to 

5:00 pm EST. Providers can also help 

patients determine their eligibility 

and the programs that are right for 

them with the tools available at: www. 

access2wellness.com. Here are tips to 

help you get started. 

Online Process 

1. Use the online Eligibility Tool (www. 

access2wellness.com/a2w/hcp-helping.html) 

to determine your patient’s 

eligibility to receive prescription 

medicines. 

2. If your patient appears to qualify 

for the Johnson & Johnson Patient 

Assistance Foundation, a link to the 

online application will be provided in 

the Eligibility Tool results. 

3. Help your patient fill out the patient 

portion of the application. Fill out 

the prescriber’s portion and click 

SUBMIT. 

4. A representative will contact both 

you and your patient to complete the 

application process. 

5. A program specialist will review the 

application and a determination will 

be made within several days. 

6. If your patient appears to qualify for 

58 

Randolph Cancer Center, 

North Carolina 

 


programs other than the Johnson & 

Johnson Patient Assistance Foundation, 

links to program websites and 

Call Centers may also be provided. 

Paper Application Process 

(Note: The following process only 

applies to the Johnson & Johnson Patient 

Assistance Foundation.) 

1. Print the Johnson & Johnson Patient 

Assistance Foundation application. It 

is available online at: www.jjpaf.org/ 

resources/jjpaf-application.pdf. 

2. Help your patient fill out the patient 

portion of the application and fill out 

your portion. 

3. Be certain your patient has included 

a copy of his or her Federal Income 

Tax Return when applicable, and 

an “Authorization to Share Health 

Information for Patient Assistance” 

(included with application), signed by 

the patient. 

4. Mail the completed application to: 

Johnson & Johnson Patient Assistance 

Foundation, PO Box 221857, 

Charlotte, NC 28222-1857. You 

can also fax the application to: 

888.526.5168. 

5. After the application is received, it is 

reviewed and a determination is made 

within several days. Note: Incomplete 

applications often cause delays. For 

information on issues that may cause 

delay, visit our Frequently Asked 

Questions at: www.access2wellness. 

com/a2w/hcp-faq.html. 


Accessone ® 

This reimbursement portal (www. 

janssenaccessone.com) offers general 

reimbursement information and news. 

By clicking on a product logo, providers 

can access drug-specific reimbursement 

information. 

The information provided represents 

no statement, promise, or guarantee by 

Janssen Products, LP, concerning levels of 

reimbursement. Please consult your payer 

organizations with regard to local or actual 

coverage and reimbursement policies and 

determination processes. 

DOXILine 

(www.janssenaccessone.com/pages/doxil/ 

index.jsp) 

This website provides easy access to 

reimbursement information and support 

including: 

●● 

Benefit verification. An online benefit 

verification form is available online 

at: www.janssenaccessone.com/ 

assets/doxil/benefit.verification.pdf. 

●● 

●● 

●● 

●● 

●● 

Prior authorization research. 

Appeal process and procedure 

research. 

Alternate sources of payment. 

General billing and coding questions. 

Information regarding patient 

assistance. 

Under the “Helpful Resources” button 

(www.janssenaccessone.com/pages/doxil/ 

pubs/publications.jsp), providers can 

access publications and toolkits for billing 

professionals to help with reimbursement 

issues, including: 

●● 

●● 

●● 

●● 

A reimbursement overview. 

A reimbursement toolkit (www. 

janssenaccessone.com/pages/doxil/ 

pubs/tool/onc.jsp) where providers 

can download tools to help prepare 

claims. A sample Evaluation 

and Management Progress Note is 

available online at: www.janssenaccessone.com/pages/doxil/pubs/tool/ 

emp.jsp. A sample chemotherapy 

treatment notes/flow sheet is available 

online at: www.janssenaccessone. 

com/pages/doxil/pubs/tool/ctn.jsp. 

Full prescribing information. 

Online reimbursement and healthcare 

resources that provide links to medical 

and journal sites, Medicare Part A 

fiscal intermediaries, Medicare Part 

B Carrier sites, payer directories, and 

more. 

For more information, call 1.800.609.1083, 

Monday through Friday, 8:00 am to 

8:00 pm EST. 

PROCRITline 

(www.janssenaccessone.com/pages/procrit/patientassist/intro.jsp) 



including: 

●● 

●● 

●● 

●● 

Benefit verification. An online benefit 

verification form is available online 

at: www.janssenaccessone.com/ 

assets/procrit/benefit.verification.pdf 

Prior authorization research 

Appeal process and procedure 

research 

Alternate sources of payment 

●● 

●● 

General billing and coding 

questions 

Information regarding patient 

assistance. 

Under the “Helpful Resources” button 

(http://www.janssenaccessone.com/ 

pages/procrit/pubs/publications.jsp), 

providers can access publications and 

toolkits for billing professionals to help 

with reimbursement issues, including: 

●● 

●● 

●● 

●● 

A reimbursement overview 

Articles on current topics in Medicare 

reimbursement 

Reference guides to ICD-9-CM 

Diagnosis Codes 

Full prescribing information. 

ZytigaOne Support 

(www.janssenaccessone.com/pages/ 

zytiga/index.jsp) 



including: 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

ZytigaOne Support Patient Brochure 

(www.janssenaccessone.com/assets/ 

zytiga/Patient_Brochure.pdf). 

ZytigaOne Support Provider Brochure 

(www.janssenaccessone.com/ 

assets/zytiga/Provider_Brochure. 

pdf). 

ZytigaOne Instant Savings Program 

Flashcard (www.janssenaccessone. 

com/assets/zytiga/instant_savings. 

pdf). 

ZytigaOne Support Enrollment Form 


zytiga/PEF.pdf). This form combines 

the benefit investigation request, 

patient authorization, ZytigaOne 

support enrollment, and prescription 

information into one form. 

A sample letter of medical necessity 


zytiga/Sample_LMN.pdf). 

Specialty pharmacy information 


zytiga/SPP.pdf). This is a list of 

specialty pharmacy provider phone 

numbers for you to use as a resource 

for therapy with Zytiga. It includes 

a listing of key services provided by 

ZytigaOne Support. 

A Business Associate Agreement 


zytiga/BAA.pdf). Use this Janssen 

Biotech, Inc. Support System HIPAA 

Business Associate Agreement to be 

HIPAA compliant. 

59 


Merck 

www.merck.com 

Oncology-related products: Emend ® (aprepitant), Emend ® 

(fosaprepitant dimeglumine) for Injection, Emend ® (fosaprepitant 

dimeglumine) for Injection, Intron ® A (interferon alfa-2b, recombinant) 

for Injection, Sylatron(peginterferon alfa-2b) for Injection, Temodar ® 

(temozolomide), Temodar ® (temozolomide) for Injection, Zolinza 

(vorinostat) 

Vaccine: Gardasil (Quadrivalent Human Papillomavirus Recombinant 

Vaccine) 

3. Take the completed application to the 

provider. Both the provider and the 

patient must sign the application. 

4. When complete, fax the enrollment 

application to: 866.363.6389. 

Providers and patients can also call the 

ACT Program at: 1.866.363.6379 to 

request a brochure and enrollment form. 

ACT Program Specialists are available 

Monday through Friday from 8:00 am to 

8:00 pm EST to answer questions about 

the program. 

60 



www.merck.com/merckhelps 


The ACT Program 

This program provides free reimbursement 

support services to help answer 

questions related to insurance coverage 

and reimbursement. The ACT Program 

also refers patients to patient assistance 

programs, which provide certain medicines 

free of charge to eligible individuals, 

primarily the uninsured, who cannot 

afford their Merck medicines. Many 

Merck medicines are included in this 

program. A partial list of Merck medicines 

follows. Call The ACT Program at 

1.866.363.6379 for the full list of covered 

products. 

●● 

Emend (aprepitant) 

●● 

Emend (fosaprepitant dimeglumine) 

for Injection 

●● 

Intron A (interferon alfa-2b, recombinant) 

for Injection 

●● 

Sylatron (peginterferon alfa-2b) 

●● 

Temodar (temozolomide) 

●● 

Zolinza (vorinostat). 

Patient Assistance for Eligible Patients 

Program Specialists can also help 

providers apply for the patient assistance 

program that provides certain Merck 

medicines free of charge to eligible 

patients who do not have insurance 

coverage. Patients may qualify for patient 

assistance if they meet all three of the 

following conditions: 

1. They are a U.S. resident and have a 

prescription for a Merck medicine 

from a doctor licensed in the United 

States. 

2. They do not have insurance or other 

coverage for their prescription 

medicine. 

3. They cannot afford to pay for their 

medicine. They may qualify for the 

patient assistance program if they 

have a household income of $55,850 

or less for individuals, $75,650 or less 

for couples, or $115,250 or less for a 

family of four. 

At Merck we realize that sometimes 

exceptions need to be made based on 

the patient’s individual circumstances. 

Patients that do not meet the prescription 

drug coverage criteria and whose income 

meets the program criteria and who have 

special circumstances of financial and 

medical hardship that apply to their 

situation can request that an exception 

be made. 

Enrollment 

ACT Program Specialists can help 

providers and patients answer questions 

related to insurance coverage and reimbursement. 

They can also explain program 

requirements and available options. 

The patient and the healthcare provider 

must complete an enrollment form. In 

brief, here are enrollment instructions: 

1. Download the enrollment application 

at: www.merck.com/merckhelps/pdf/ 

ACT_Enrollment_Form.pdf (English) 

and www.merck.com/merckhelps/ 

pdf/El_Programa_ACT_espanol.pdf 

(Spanish). 

2. Complete all information on the 

application form. Patients can fill in 

the fields online and print or they may 

print the form and fill it out by hand 

using a black ballpoint pen. 

Merck Co-Pay Assistance Program 

This program is available to eligible, 

privately insured patients who may need 

help affording their co-pay on certain 

Merck oncology medicines. If patients 

have been prescribed one of the Merck 

medicines included in the program and 

they are privately insured, they may be 

eligible for the Merck Co-Pay Assistance 

Program if they meet the full program 

criteria. A partial list of Merck medicines 

covered in this program include: 

●● 

●● 

●● 

●● 

Intron A (interferon alfa-2b, 

recombinant) for Injection 

Sylatron (peginterferon alfa-2b) 

for Injection 

Temodar (temozolomide) 

Zolinza (vorinostat). 

Selected criteria for Merck’s Co-Pay 

Assistance Program includes: 

●● 

The program is not available for all 

Merck products. Call the number 

below to find out if the medicine 

the patient has been prescribed is 

included. 

●● 

●● 

●● 

●● 

Patients must meet the program’s 

income eligibility criteria. 

Financial assistance is not transferable. 

It cannot be combined with any 

coupon, free trial, discount, prescription 

savings card, or other form of 

patient assistance. 

Financial assistance is not insurance. 

The Merck Co-Pay Program is valid 

for patients with private insurance. It 

is not valid for cash-paying patients 

or patients covered under Medicaid, 

Medicare, a Medicare Part D or 

Medicare Advantage Plan (regardless 

of whether a specific prescription 

is covered), TRICARE, CHAM- 

PUS, Puerto Rico Government 

Health Insurance Plan (“Healthcare 

Reform”), or any other state or federal 

 


●● 

●● 

●● 

●● 

●● 

●● 

●● 


offering financial assistance services 

can improve the patient (and provider) 

experience. An experienced cancer 

program administrator outlines 

strategies for: 

■■ 

■■ 

■■ 

Improving how patients move 

through your cancer program. 

Flow chart the patient experience 

and look for ways to improve or 

streamline services. 

Developing patient and provider 

education materials. 

Marketing financial assistance 

services to increase referrals from 

primary care physicians. 

medical or pharmaceutical benefit 

program or pharmaceutical patient 

assistance program. 

Not valid for residents of 

Massachusetts. 

The program can only be used by 

eligible U.S. or Commonwealth of 

Puerto Rico residents at participating 

eligible retail or mail-order pharmacies 

in the United States or the Commonwealth 

of Puerto Rico. Product 

must originate in the United States or 

the Commonwealth of Puerto Rico. 

Merck reserves the right to rescind, 

revoke, or amend the offer at any time 

without notice. 

Financial assistance is provided for up 

to 12 months of therapy. If necessary, 

patients must reapply for assistance 

annually. 

The program may not cover all of the 

patient’s out-of-pocket expenses. 

It is illegal to sell, purchase, or trade, 

or offer to sell, purchase, or trade the 

financial assistance. Void where prohibited 

by law, taxed, or restricted. 

There is no guarantee funding will be 

Randolph Cancer Center, North Carolina 

Improving the Patient Experience 

■■ 

■■ 

available in any subsequent year or 

timeframe. 

Visit www.merck.com/product/ to view 

Patient Information and discuss with 

your patient. For full program criteria or 

more information, call 855.263.1774. 

Vaccine Patient Assistance Program 

Patients who want to receive the Gardasil 

vaccine may be eligible for the program 

if all three of the following conditions 

apply: 

●● 

●● 

●● 

Marketing financial assistance 

services to patients and families. 

Measuring patient and provider 

satisfaction with these services. 





Patients reside in the U.S. and are age 

19 or older. (Note: Patients do not 

have to be U.S. citizens.) 

Patients have no health insurance 

coverage. (Some examples of health 

insurance coverage include private 

insurance, HMOs, PPOs, college 

health plans, Medicaid, Veterans’’ 

assistance, or any other social service 

agency support.) 

Patients have an annual household 

income less than: $44,680 for individuals, 

$60,520 for couples, or $92,200 

for a family of four. (For income 

limits in Alaska, Hawaii, Puerto Rico, 

U.S. Virgin Islands, and Guam, please 

call 1.800. 293.3881.) 

Enrollment is easy. 

1. Complete and sign the application 

form. It is available online at: www. 

merck.com/merckhelps/vaccines/ 

mvpap_app.pdf (English) and www. 

merck.com/merckhelps/vaccines/ 

mvpap_app_span.pdf (Spanish). 

Providers and their office personnel 

can also call 800.293.3881 to obtain 

enrollment applications for patients 

and to request additional information 

about the program. 

2. Fax the completed form to: 

800.528.2551 from a participating 

licensed provider’s office. The application 

must be submitted and approved 

prior to administration of vaccine 

in order to qualify. Forms will be 

processed quickly—with a goal of less 

than 10 minutes—and the provider’s 

office will be notified by phone so that 

qualifying patients can receive the 

Merck vaccine during that visit. 

3. A new application will need to be 

completed and submitted to the 

Merck Vaccine Patient Assistance 

Program for eligibility assessment 

prior to a patient receiving a subsequent 

dose in a multi-dose series or 

for another Merck vaccine. 


The ACT Program 

The ACT Program assists providers with 

insurance coverage and reimbursement 

questions. ACT Program Specialists can 

help providers answer questions related to 

insurance coverage and reimbursement. 

Services include: 

●● 

Researching medical insurance and 

prescription plan benefits 

●● 

Verifying out-of-pocket costs 

●● 

Conducting searches for other sources 

of assistance 

●● 

Referring individuals to patient 


For additional information and reimbursement 

support, call the ACT Program 

at 866.363.6379, Monday through 

Friday, 8:00 am to 8:00 pm EST. 

The ACT Program does not guarantee 

either coverage or a specific reimbursement 

rate for any Merck medicine. 

61 


Millennium: The Takeda Oncology Company 

www.millennium.com 

Oncology-related Product: Velcade ® (bortezomib) 



www.velcade-hcp.com/ 

reimbursement 


If a patient has no insurance coverage for 

Velcade, he or she may be eligible to participate 

in the company’s Patient Assistance 

Program. For patients who qualify 

for the program, free Velcade product 

will be delivered to their healthcare 

professionals. For patients with denied 

insurance coverage, please contact your 

dedicated Velcade Reimbursement Assistance 

Program (VRAP) case manager by 

calling 866.VELCADE (866.835.2233) 

and choosing option 2 to inquire about 

potential product replacement. 

Enrollment Process 

Patients who do not have insurance 

coverage for Velcade must apply for 

assistance through their healthcare 

professionals. To demonstrate eligibility, 

they must complete an enrollment form 

and provide income documentation, as 

well as health insurance information. The 

form is available online at: www.velcade- 

hcp.com/reimbursement/forms/VEL- 

CADE_VRAP_Enrollment_Form.pdf. 

You can also receive the enrollment form 

by calling 866.VELCADE (866.835.2233) 

and choosing option 2. It is strongly recommended 

that you enroll patients into 

the Patient Assistance Program prior to 

the start of their treatment with Velcade. 

All enrollment forms must be received 

within six months of the first treatment 

for complete assistance. 

Enrollment Assessment 

VRAP will respond by telephone within 

two business days to any completed 

enrollment application. A follow-up letter 

explaining the determination will be 

sent to the healthcare professional. If the 

patient qualifies, your dedicated case manager 

will contact your office to schedule a 

shipment of the first cycle of Velcade. 

Enrollment Management 

One week prior to every cycle, your 

dedicated case manager will contact you 

to confirm that the patient will continue 

to receive Velcade and that the patient’s 

information remains unchanged. Patients 

are eligible to participate in the Patient 

Assistance Program for 12 months if they 

remain qualified. If they are still receiving 

Velcade after 12 months, they will 

need to re-enroll in the program. 

62 

Four Steps to Access Velcade 

1. Talk to Your Patients. Discuss any questions 

patients may have regarding treatment and 

the impact it will have on their out-of-pocket 

expenses. You are a resource for patients 

regarding what to expect from their treatment 

and how different treatment regimens may be 

impacted by their insurance coverage. You can 

also refer patients to other useful resources. 

2. Provide Insurance Information. Make sure 

that you have your patient’s current insurance 

information so that you can verify coverage. 

Research your patient’s insurance coverage to 

determine if Velcade will be covered, if additional 

documentation will need to be submitted 

to the insurance company, and how much 

patients will need to pay for their treatment 

based on their insurance plan. If the patient’s 

insurance covers Velcade, move on to the 

payment and scheduling processes outlined in 

steps 3 and 4. If the insurance company requests 

additional information, you may need to submit 

a letter stating the reason(s) why your patient 

should be treated with Velcade. The insurance 

company will notify both you and your patient 

about their decision. If coverage is approved, 

move on to the payment and scheduling processes 

outlined in steps 3 and 4. If the patient’s 

insurance company requests additional information 

and does not approve treatment based on 

what you have provided, then you may be able to 

get assistance through the Velcade Reimbursement 

Assistance Program (VRAP). 

3. Understand the Payment Process. Depending 

on the patient’s specific insurance coverage, 

his or her out-of-pocket expense will vary. It 

is important to help your patients understand 

these details, and to know where they can 

go for help. Ensure that your patients know 

exactly what dollar amount they are going to 

be responsible for paying, according to their 

insurance policy. 

4. Schedule the Treatment. Once you have 

helped your patient determine how he or she 

will be able to pay for Velcade, schedule the 

treatment. Velcade is given as a 3- to 5-second 

IV injection in a doctor’s office or at a hospital 

outpatient clinic. 

Source: www.velcade.com. 

 


Reimbursment Assistance 

The Velcade Reimbursement 

Assistance Program 

Today’s economy has made it more 

challenging than ever for patients receiving 

therapy. Millennium Pharmaceuticals, 

Inc., understands that challenge and 

has responded with an enhanced Velcade 

Reimbursement Assistance Program 

service model. 

●● 

●● 

One-to-one support model. You 

now have a dedicated case manager 

waiting for your call. Millennium has 

invested in a dedicated case manager 

model so that, each time you call, you 

will be assisted by the same person. 

Targeted solutions. Patients’ needs 

differ significantly, depending on 

many factors. The “one-to-one” support 

model allows case managers to be 

experts at identifying resources that 

are specific to the state, county, or city 

in which your patient either lives or 

receives therapy. Increasing demand 

on the national resources available to 

patients makes it more important than 

ever to identify available resources for 

a patient. Whether a patient’s need is 

related to a complex prior authorization 

process or identifying viable transportation 

resources, your “one-to-one” 

case manager is waiting to help. 

When healthcare providers, patients, or 

caregivers call VRAP, dedicated case 

managers are available to answer 

questions and provide helpful information. 

For more information, call 866. 

VELCADE (866.835.2233) and choose 

option 2. VRAP services are available 

Monday through Friday, from 8:00 am 

to 8:00 pm EST. Information can also be 

mailed or faxed to the provider’s office or 

the home of a patient or caregiver. 

●● 

●● 

●● 

any questions you have about coding 

and billing for Velcade, provide you 

with sample claim forms, and help 

you track and monitor claim forms. 

Claim appeals support. Identify 

reasons for underpayment or denial 

of claims, contact insurers to gather 

information about the appeal process, 

and assist you in developing an appeal 

strategy, including sample letters of 

medical necessity and appeal. (Note: 

VRAP does not file claims or appeal 

claims for callers, nor can it guarantee 

that you will be successful in obtaining 

reimbursement.) 

Alternate funding searches. Determine 

additional sources of support for 

uninsured and underinsured patients 

on Velcade and assist in the application 

process. 

Transportation resources. Identify 

transportation resources for patients 

on Velcade. 

Velcade.com for Healthcare 

Professionals 

As part of the enhanced Velcade Reimbursement 

Assistance Program, you 

can also find Velcade reimbursement 

information online at: www.velcade.com/ 

payingfortreatment.aspx. The healthcare 

professional reimbursement section 

offers tools that will help you navigate 

the healthcare coverage environment for 

Velcade, including: 

●● 

●● 

Coverage. Find information about 

Medicare, Medicaid, and private 

payer coverage for Velcade. 

Payment for Velcade. Learn about 

the payment methodologies used 

by different payers to determine 

reimbursement for Velcade. 

●● 

●● 

Coding. Find information on coding 

claims for Velcade. 

A Forms Library. Download sample 

claims forms and letters, including: 

1. A Quick Reference Guide 

containing information for 

payer coding and payment 

information for Velcade at: www. 

velcade-hcp.com/reimbursement/ 

forms/QRG_PI.pdf. 

2. Sample CMS-1500 Claim Form at: 

www.velcade-hcp.com/reimbursement/forms/CMS-1500_withPI.pdf. 

3. Sample CMS-1450 (UB-04) Claim 

Form at: www.velcade-hcp.com/ 

reimbursement/forms/CMS-1450_ 

withPI.pdf. 

4. Sample Letter Supporting Medical 

Necessity for Velcade at: www. 


formslibrary_ form_3.aspx. 

5. Sample Letter Appealing a 

Denied Claim for Velcade at: 

www.velcade-hcp.com/reimbursement/forms/Appeal_withPI.pdf. 

6. Sample Letter to Obtain Consistent 

Medicare Coverage at: www. 


forms/Obtain_withPI.pdf. 

Velcade.com for Your Patients 

At www.velcade.com, you will also find 

reimbursement information for your 

patients, including: 

●● 

●● 

●● 

Health insurance coverage and payment 

options for Velcade 

The coverage process from the 

patient’s perspective 

Questions to ask their doctor’s office. 

Reimbursement 

Trained reimbursement case managers 

are available to provide timely and accurate 

information and services, including: 

●● 

●● 

●● 

Insurance verification. Verify health 

insurance coverage and eligibility for 

each patient being treated with 

Velcade, facilitate the prior authorization 

process, and determine any 

co-payment obligations. 

Research payer policies. Provide published 

policies for public and private 

payers. 

Coding and billing support. Discuss 

63 


Novartis Pharmaceuticals Corporation 

64 

www.novartisoncology.com 

Oncology-related products: Oncology-related products: Afinitor ® 

(everolimus tablets), Exjade ® (deferasirox), Femara ® (letrozole 

tablets), Gleevec ® (imatinib mesylate) tablets, Sandostatin LAR ® 

Depot (octreotide acetate for injectable suspension), Sandostatin ® 

(octreotide acetate for injection), Tasigna ® (nilotinib) tablets, and 

Zometa ® (zoledronic acid) Injection 



www.patientassistancenow. 

com 


The Novartis Patient Assistance 

Foundation 

The Novartis Patient Assistance Foundation 

(PAF) provides assistance to patients 

experiencing financial hardship who 

have no third-party insurance coverage 

for their medicines. To be eligible for 

the Novartis PAF, patients must: 

●● 


●● 

Meet income criteria, which vary 

by medication, and provide proof of 

income. Financial eligibility program 

requirements are 250% to 500% of 

the Federal Poverty Level (FPL), 

depending on the Novartis Medicine. 

The Federal Poverty Level defines the 

minimum yearly income that a person 

or family needs in order to provide 

for its basic needs. It is adjusted each 

year by the Department of Health 

and Human Services (HHS). This 

level dictates a set of guidelines for 

use for administrative purposes—for 

instance, determining financial eligibility 

for certain federal programs. 

●● 

Not have private or public prescription 

coverage. (Note: There is an 

exception process for patients who 

cannot afford their Medicare Part D 

or B cost share.) 

Patients must reapply and requalify 

annually. Questions Contact the 

Novartis Patient Assistance Foundation 

at: 800.277.2254 or go online to: www. 

patientassistancenow.com. 

Enrolling in the PAF is quick and 

easy. To provide the best possible 

customer service, we recommend that 

the provider or patient call our hotline. 

Providers or patients will be asked a few 

qualifying questions to determine patient 

eligibility for the program. To get started, 

call 1.800.277.2254 and select the appropriate 

phone prompts. (Please note: for 

patients prescribed Exjade, the provider 

Skagit Valley Hospital Regional 

Cancer Care Center, Washington 

or patient should call the EPASSnPrescription 

and Reimbursement Hotline at: 

1.888.903.7277.) 

If the patient appears to be eligible 

based on the initial phone screening, 

PAF will provide a temporary supply of 

medication and an application will be 

mailed directly to the patient’s home. 

Once received, the provider and patient 

must complete the first four sections 

of the application. Include the patient’s 

signature, the date, a copy of the patient’s 

most recent federal tax return, and a copy 

of his or her insurance card/prescription 

card, if applicable. The provider must 

complete and sign the lower portion of 

the enrollment application. 

Applications are available online 

at: www.pharma.us.novartis.com/cs/ 

groups/public/@nph_us_it/documents/ 

contentpage/n_int_050277.pdf (English) 

and www.pharma.us.novartis.com/cs/ 

groups/public/@nph_us_it/documents/ 

contentpage/n_int_050278.pdf (Spanish). 

Completed applications should be 

faxed to: 1.866.277.9335 or mailed to: 

Novartis Oncology Patient Assistance 

Program, PO Box 6655, St. Louis, MO 

63166-6559. Once received, we will 

assess for full eligibility for the patient 

assistance program. Qualified individuals 

are eligible for up to one year of assistance, 

or until a prescription drug benefit 

becomes available. Upon approval, up 

to a year supply of medication will 

be shipped directly to the provider or 

patient. 

Patient Assistance NOW Oncology 

(www.oncologyaccessnow.com/index.jsp) 

Novartis Patient Assistance NOW 

Oncology (PANO) offers quick and easy 

access to information about the many 

reimbursement and support programs 

available. PANO helps you understand 

the issues, options, and requirements 

pertinent to patients’ access to therapies, 

with: 

●● 

●● 

Patient access to treatment 

Provider portals to access PANO 

 


Total Yearly Income Range 

Onyx Pharmaceuticals 

66 

www.onyx.com 

Oncology-related products: Kyprolis ® (carfilzomib) for Injection, 

Nexavar ® (sorafenib) tablets (co-marketed with Bayer HealthCare 




www.onyx.com/therapies/ 

patient-access/onyx-360 


Onyx 360 

This comprehensive, personalized 

program is designed to support providers 

and patients in their health journey by 

providing services and referrals that meet 

their individual needs, including: 

●● 

Free product assistance for uninsured 

patients or those rendered uninsured 

through payer denial and who meet 

●● 

●● 

certain income eligibility criteria 

Referral to transportation assistance 

services for those patients who 

qualify and need assistance paying 

for gas, lodging, tolls, and parking 

in connection with receiving therapy 

Referral to support services for 

patients, families, and caregivers that 

provide product information, local 

transportation to scheduled appointments, 

support group information, 

nutritional information, and side 

effect management, along with practical 

matters related to the patient’s 

condition. 

Download and complete the enrollment 

form at: www.onyx.com/file. 

cfm/623/docs/5608%20Enrollment%20 

Form_Corp_Web_Version_0712- 

ONYX-109_072312.pdf. Please see 

required information below for each 

Reporting Financial Assistance Processes and 

Data Back to Internal Stakeholders 


to identify and collect the right data 

to ensure your program is delivering 

high-quality and efficient financial 

assistance services. An experienced 

quality and improvement manager 

shares how to: 

■■ 

■■ 

■■ 

Identify data sets to track and 

report back to stakeholders, such 

as percent of charity care, costs 

of drugs obtained through drug 

replacement programs, and more 

Forecast the number of patients 

that may need financial assistance 

services 

Forecast the revenue (drug 

replacement) or savings (reduced 

bad debt, write-offs, and charity 

care) that financial assistance 

services may bring to the cancer 

program 

■■ 

Develop a process for tracking 

metrics, including the number of 

patients that use these services, 

revenues and cost-savings, 

improvements in patient compliance, 

and improved patient and 

provider satisfaction. 





requested service. Failure to include all 

information will delay the process. 

For insurance verification: 

✔✔ 

Complete sections 1, 2, and 3 

✔✔ 

Physician signature is required 

✔✔ 

Fax a copy of the front and back of 

the patient’s insurance card with the 

enrollment form. 

For free product assistance: 

✔✔ 

Complete sections 1, 2, 3, 4, and 5 

✔✔ 

Patient’s financial documentation will 

be required (i.e., most recent 1040 

federal tax return, W-2, or social 

security statement) 

✔✔ 

Physician and patient signatures are 

required. 

For co-pay assistance (for eligible 

patients): 

✔✔ 


✔✔ 

Physician and patient signatures are 

required. 

For referrals to transportation cost 

assistance: 

✔✔ 

Complete sections 1 and 2 

✔✔ 

Patient signature is required. 

For referral to patient support services: 

✔✔ 


✔✔ 

Patient signature is required. 

Please fax completed forms to Onyx 360 

at: 1.855.669.9329. Upon submission of 

the enrollment form to Onyx 360, an 

oncology nurse advocate will confirm 

receipt with the provider and initiate 

the services requested on behalf of the 

patient(s). Questions Oncology nurse 

advocates are available Monday through 

Friday, from 9:00 am to 8:00 pm EST 

at 1.855.ONYX.360 (1.855.669.9360) 

to help guide providers and patients 

through the specifics of the program(s) 

and answer any questions. 


Onyx 360 provides the following reimbursement 

assistance to providers: 

●● 

Co-pay and co-insurance assistance 

●● 

Comprehensive insurance verification 

●● 

Prior authorization and appeals 

process support. 

To learn more about these services, call: 

1.855.ONYX.360 (1.855.669.9360). 

 


Pfizer Oncology 

www.pfizer.com 

Oncology-related products: Aromasin ® (exemestane tablets), 

Bosulif ® (bosutinib) tablets, Camptosar ® (irinotecan HCI injection), 

Ellence ® (epirubicin hydrochloride injection), Emcyt ® (estramustine 

phosphate sodium capsules), Idamycin ® (idarubicin hydrochloride 

for injection, USP), Inlyta ® (axitinib) tablets, Neumega ® (oprelvekin), 

Sutent ® (sunitinib malate), Torisel ® (temsirolimus) injection, Xalkori ® 

(crizotinib) capsules, Zinecard ® (dexrazoxane for injection) 



www.pfizerhelpfulanswers. 

com 

Pfizer Helpful Answers 

Pfizer Helpful Answers is a family of 

assistance programs for people who have 

no insurance, or who do not have enough 

insurance and need help getting their 

Pfizer medicines. Programs may provide: 

●● 

●● 

Pfizer medicines for free or at a savings 

to patients who qualify 

Reimbursement support services to 

insured patients. 

If your patient is uninsured or underinsured 

and would like more information 

about Pfizer Helpful Answers 

assistance programs, call us toll-free at: 

1.866.706.2400, or view all assistance 

programs online at: www.pfizerhelpfulanswers.com/pages/Find/FindAll.aspx. 



Pfizer First Resource ® offers reimbursement 

support services and patient 

assistance to help patients gain access to 

Pfizer oncology medicines. If the patient 

qualifies, the program can also provide 

co-pay assistance for certain medicines. 

A Pfizer First Resource counselor will 

help confirm if a patient is eligible for 

assistance, and can guide the provider 

and patient through the enrollment process. 

Download the Pfizer First Resource 

brochure (pfizerhelpfulanswers.com/ 

files/First%20Resource%20Brochure_ 

Sutent%20PI_Final%20File_9_27_11. 

pdf) for more information on how this 

program can help you. 

To receive free medicines, patients must: 

●● 

Have no prescription coverage or not 

enough coverage 

●● 

Meet specific income guidelines, 

adjusted for family size 

●● 

Live in the United States, the U.S. 

Virgin Islands, or Puerto Rico 

●● 

Be treated by a licensed doctor in the 

United States or Puerto Rico. 

The following medicines are available 

through the First Resource program: 

Aromasin (exemestane tablets) 

Bosulif (bosutinib) tablets 

Camptosar (irinotecan HCI 

injection) 

Ellence (epirubicin hydrochloride 

injection) 

Emcyt (estramustine phosphate 

sodium capsules) 

Idamycin (idarubicin hydrochloride 

for injection, USP) 

Inlyta (axitinib) tablets 

Neumega (oprelvekin) 

Sutent (sunitinib malate) 

Torisel (temsirolimus) injection 

Xalkori (crizotinib) capsules 

Zinecard (dexrazoxane for injection). 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

Enrollment Instructions 

To apply to First Resource: 

●● 

Download First Resource IV application 

online in English (www.pfizerhelpfulanswers.com/files/9565_FirstResourceIV_rev8.pdf) 

or Spanish 

(www.pfizerhelpfulanswers.com/ 

files/14634_FirstResource2IV_Sp.pdf) 

or call 1.877.744.5675 to begin the 

enrollment process. First Reach counselors 

are available Monday through 

Friday, 9:00 am to 8:00 pm EST and 

offer assistance in English or Spanish. 

●● 

Download First Resource oral 

application online at: www.pfizerhelpfulanswers.com/files/FirstResource_English%20Oral%20App. 

●● 

pdf or call 1.877.744.5675 to begin the 

enrollment process. 

The provider and patient must fill out 

and fax or mail the completed application, 

along with proof of income for 

continued assistance (if approved), 

to 1.800.708.3430, or to: Pfizer First 

Resource PO Box 220582 Charlotte, 

NC 28222-0582. Proof of income 

includes copies of one of the following 

documents that show a patient’s 

total gross annual household income: 

current paycheck stub; federal tax 

return for the prior tax year (Form 

1040 or 1040EZ); wage and tax statements 

(W2 form); Social Security, 

pension, or railroad retirement 

statements (SSA-1099 or similar); and 

statements of interest, dividends, or 

other income (1099-INT, 1099, 1099- 

DIV, or other forms). 

Proof of income includes copies of one of 

the following documents that show total 

gross annual household income: 

●● 

●● 

●● 

●● 

●● 

Current paycheck stub 

Federal tax return (Form 1040 or 

1040EZ) for the prior tax year 

Wage and tax statements (W-2 forms) 

Social Security, pension, or railroad 

retirement statements (SSA-1099 or 

similar) 

Statements of interest, dividends, 

or other income (1099-INT, 1099, 

1099-DIV or other forms). 

If you do not have any proof of income, 

please call us at 1.866.706.2400. 

Insured Patients 

For patients with prescription drug 

coverage, First Resource can provide the 

following benefits: 

●● 

●● 

●● 

Reimbursement support services. A 

First Resource counselor will research 

and verify patient benefits for the 

medicine needed, explain coverage 

options and policies, and investigate 

and explain the prior authorization 

process. 

Alternate funding assistance. First 

Resource can help providers and 

patients find alternate sources of 

funding if necessary. These may 

include state pharmaceutical assistance 

programs, Medicaid, Medicare 

Part D, low-income subsidies, and 

charitable foundations. 

Appeals process information. If a 

67 


68 

●● 

●● 

claim is underpaid or denied, First 

Resource will investigate and explain 

the appeals process. 

Specialty pharmacy referral. If 

patients are insured and have been 

prescribed Xalkori or Inlyta, First 

Resource will refer them to an appropriate 

specialty pharmacy that can fill 

the prescription. 

Hardship assistance. If patients have 

prescription coverage but are experiencing 

significant financial hardship 

(e.g., cannot afford their co-pay or 

coinsurance), they may be eligible to 

receive their Pfizer medicine for free, 

or obtain a Co-Pay Card that will 

cover the full cost of their co-pay. 

Pfizer Pfriends 

Regardless of age and income, if patients 

qualify, a Pfizer Pfriends card can 

offer savings on many branded Pfizer 

medicines at participating pharmacies. 

To receive a savings on Pfizer medicines 

through the program, patients must: 

●● 

●● 

Have no prescription coverage 

Live in the United States, Puerto 

Rico, or the U.S. Virgin Islands. 

To apply to Pfizer Pfriends: 

1. Download an application online at: 

www.pfizerhelpfulanswers.com/files/ 

PP_English.pdf (English) or www. 

pfizerhelpfulanswers.com/files/PP_ 

Spanish.pdf (Spanish). Providers and 

Lake Region Healthcare, Cancer Care 

and Research Center, Minnesota 

patients can also request applications 

by calling 1.866.706.2400. 

2. Complete the application, which covers 

the entire family. Proof of income 

is not required. 

The application will be processed in two 

to three weeks. If approved, patients will 

receive a welcome kit in the mail. This 

kit includes the Pfizer Pfriends savings 

card(s). Patients can begin using their 

savings card(s) at participating pharmacies 

when filling their prescriptions for 

Pfizer medicines. To find a participating 

pharmacy, go to: www.pfizerhelpfulanswers.com/pages/Programs/PharmacyLocator.html. 

To continue receiving Pfizer Pfriends 

program benefits, patients must reapply 

each year. 

●● 

●● 

●● 


Pfizer First Resource 

Through Pfizer’s First Resource Program, 

providers can access the following 

services: 

●● 

Reimbursement support services. 

A First Resource counselor can help 

patients and healthcare professionals 

understand coverage and reimbursement 

options. This includes benefits 

verification, in which the counselor 

will review patients’ benefits to see 

how they are covered for the medicines 

they need. They’ll also explain 

coverage options and policies, as well 

as investigate and explain the prior 

authorization process. 

Alternate funding assistance. First 

Resource can help patients find 

alternate sources of funding if they 

need them. These may include state 

pharmaceutical assistance programs, 

Medicaid, Medicare Part D, lowincome 

subsidies, and charitable 

foundations. 

Appeals process information. If a 

claim is underpaid or denied, First 

Resource will investigate and explain 

the appeals process. 

Specialty pharmacy referral. 

Xalkori (crizotinib) capsules or Inlyta 

(axitinib) tablets will be available only 

through select specialty pharmacies. 

A First Resource counselor can help 

patients who have been prescribed 

Xalkori or Inlyta get connected to the 

specialty pharmacy appropriate for 

their insurance plan. The specialty 

pharmacy will then conduct a benefits 

verification to determine coverage 

options and the process to receive 

Xalkori or Inlyta. Note: Services vary 

by product and eligibility. 

Pfizerpro.com 

PfizerPro (www.pfizerpro.com) provides 

access to current product information as 

well as patient education and assistance 

programs for Pfizer’s prescription 

medicines. When providers register with 

PfizerPro.com they gain access to professional 

resources, including: 

●● 

Epocrates ® 

●● 

●● 

●● 

●● 

The 5-Minute Clinical Consult 

MedPage Today ® Medical News 

Journal Reprints 

Pfizer Medical Information. 

Note: Some restrictions may apply. 

Providers also gain access to patient 

education and assistance, including: 

Pfizer Samples for Eligible Health 

Care Professionals 

A.D.A.M. Quicksheets 

Printed Literature Requests 

Pfizer Helpful Answers. 

●● 

●● 

●● 

●● 

Plus, additional product-exclusive 

programs and other offerings that may 

help you better serve your practice and 

patients. 

 


ProStrakan 

www.prostrakan-usa.com 

Oncology-related and supportive care products: Fareston ® 

(toremifene citrate); Sancuso ® (granisetron transdermal system) 



www.patientrxsolutions.com 



Our Patient Assistance Program was 

designed to assist uninsured individuals 

and those who have no public or private 

prescription coverage (e.g., Medicaid, 

Medicare prescription drug coverage, 

other charitable organizations). All 

applications are reviewed on a case-bycase 

basis. If your patients do not have 

prescription coverage, our team can help 

them explore their options. To qualify, 

patients must: 

●● 

Not be eligible for or have prescription 

drug coverage through any 

private or public prescription coverage 

program, including Medicaid and 

Medicare. 

●● 

●● 

●● 

Have an annual income at or below 

300% of the current Federal Poverty 

Level. 

Submit a recent federal tax return 

along with the application. If the 

patient does not file taxes, an alternate 

proof of income will be required. 

Be a legal resident of the U.S. or its 

territories. 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

income values on your application. 

Acceptable documents include: 

■■ 

W2 forms 

■■ 

Pay statements 

■■ 

Social security, pension, or retirement 

statements 

■■ 

Bank statements 

■■ 

Statements of interest, dividends, 

or other income. 

Sign the Applicant Declaration 

section. 

Complete the Therapy and Physician 

Information sections of the application 

in their entirety. 

Sign the Physician Certification (no 

stamped signatures will be accepted). 

Note: Physician must have completed 

the enrollment form and received a 

denial for coverage. 

Sign the separate Patient Authorization 

to Share Health Information 

form (no stamped signatures will be 

accepted). 

Fax or mail both forms to: Patient Rx 

Solutions, PO Box 8203, Somerville, 

NJ 08876, Phone: 1-866-325-8231, 

Fax: 1-866-694-2546. 

Sancuso Example: Co-pays per Fill 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

sending as no documents will be 

returned. 

Attach current proof of income 

(tax return, W2, pay stub) for all in 

household. 

Patient’s signature and date is 

required on the application. 

Prescriber’s signature and date is 

required on the application. 

Provide a copy of Medicare card or 

letter of Medicaid and/or Social 

Security denial, if applicable. 

Fax or mail both the completed 

application and documentation 

to: Patient Rx Solutions, PO Box 

8203, Somerville, NJ 08876, 

Phone: 1-866-325-8231, 

Fax: 1-866-694-2546. 

Questions Call 1.866.325.8231, 9:00 am 

to 5:00 pm EST. 

Sancuso Co-pay Assistance Card 

Program 

Each card can save your patients up to 

$2,200 over 11 Sancuso prescription 

fills; in no case will the monthly benefit 

exceed $200. Here’s how the program 

works: 1) patients can save up to $200 on 

each prescription after paying the first 

$30 and 2) each card is good for 11 fills, 

4 patches per fill, subject to prescription 

coverage. 

Out-of-Pocket Cost Patient Pays Co-pay Card Pays 

$75 $30 $45 

$230 $30 $200 

$300 $100 $200 

For Sancuso, download the patient 

assistance program application at www. 

patientrxsolutions.com/pdf _ files/ 

Patient_Assistance_Application.pdf and 

then follow the directions below. 

✔✔ 

✔✔ 

Complete the Applicant Information 

section of the application in its 

entirety. 

Complete the Financial Information 

section of the application in its 

entirety. Include a copy of a recent 

federal tax return. If you do not file 

taxes, the documentation support submitted 

should match with the selected 

Please be sure the physician section is 

completed before submitting your 

application. Incomplete applications 

will be returned as denied. Questions 

Call 1.800.6.SOLUTIONS, 9:00 am to 

5:00 pm EST. 

For Fareston, download the patient 

assistance application at www.patientrxsolutions.com/pdf 

_ files/Fareston_ 

Patient_Assistance.pdf and then follow 

the directions below. 

✔✔ 

Ensure all sections of the application 

are completed. Make a copy before 

Download the free Sancuso co-pay assistance 

card at www.sancuso.com/patient/ 

copay/loyaltyRX.php and follow these 

easy steps: 

1. Show this prescription card and your 

valid prescription each time you pay 

for your prescription. 

2. Pay the initial $30 of your co-pay; any 

remaining out-of-pocket costs will be 

reduced by up to $200 per month. 

3. Save your co-pay assistance card— 

this card can be used once a month for 

up to 11 prescriptions or 44 patches 

69 


St. Mary Corwin Regional Medical Center, 

Dorcy Cancer Center, Pueblo, Colorado 

70 

per patient, whichever comes first. 

Maximum 4 patches per fill. In no 

case will the monthly benefit exceed 

$200. 

Fareston Co-pay Assistance Card 

Program 

Each card can save your patients up to 

$2,400 over 12 Fareston prescription 

fills; in no case will the monthly benefit 

exceed $200. Here’s how the program 

works: 1) it offers co-pay savings of up to 

$200 toward each prescription after paying 

the first $30 for up to 12 prescriptions 

per year for eligible patients and 2) each 

Fareston Example: Co-pays per Fill 

card can be used once a month for up to 

12 prescriptions. 

Download the free Fareston co-pay assistance 

card at www.patientrxsolutions. 

com/fareston-copay and follow these 

easy steps: 

1. Show this co-pay assistance card and 

your valid prescription each time you 

pay for your prescription. 

2. Pay the initial $30 of your co-pay. 

Any remaining out-of-pocket costs 

will be reduced by up to $200 per 

month. 

3. Save your co-pay assistance card— 

this card can be used once a month for 

up to 12 prescriptions. In no case will 

the monthly benefit exceed $200. 

Sancuso Patch Replacement 

Program 

If your patient’s chemotherapy is 

delayed or canceled, the Sancuso Patch 

Replacement Program may be able to 

help receive a replacement patch. The 

application is available online at www. 

patientrxsolutions.com/pdf _ files/Patch_ 

Replacement_Application.pdf. Providers 

must work with patients to complete the 

Out-of-Pocket Cost You Pay Co-pay Card Pays 

$75 $30 $45 

$230 $30 $200 

$300 $100 $200 

application as information is needed from 

both the patient and the physician. The 

provider must also sign the application. 

Completed applications, along with a 

receipt for proof of purchase, should be 

faxed to: 1.866.258.7480. 


Prior Authorization Assistance 

Program 

If your patient has prescription insurance 

coverage, our experienced staff will 

make it easier to gain access to Sancuso 

and Fareston by working directly with 

him or her on coverage-related questions. 

The prior authorization assistance 

program: 

✔✔ 

✔✔ 

✔✔ 

Uses all available discounts and assistance 

programs to make Sancuso and 

Fareston more accessible. 

Works with retail pharmacies and 

physician dispensing pharmacies to 

provide Sancuso and Fareston. 

Can connect patients to mail order 

resources that will ship product 

directly to the patient’s home. 

The prior authorization takes between 

24 and 72 hours; however, the average 

response or status update time is less than 

24 hours. For the quickest service, fill out 

the prior authorization assistance applications 

below and fax the application and 

the prescription to 1.888.705.7852 or 

call 1.888.705.7851. Be sure to have the 

following information available when 

faxing or calling: 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

Patient information 

Prescription 

Patient’s prescription drug insurance 

card 

Physician Information. 

Download the Sancuso prior authorization 

application at www.patientrxsolutions.com/pdf 

_ files/Prior_Authorization. 

pdf and the Fareston prior authorization 

application at www.patientrxsolutions. 

com/pdf _ files/Fareston_Prior_Auth.pdf. 

 


Sanofi Oncology 

www.sanofioncology.com 

Oncology-related products: Elitek ® (rasburicase), Eloxatin ® 

(oxaliplatin), Jevtana ® (cabazitaxel), Leukine ® (sargramostim), 

Mozobil ® (plerixafor), Taxotere ® (docetaxel), Thymoglobulin ® 

(anti-thymocyte globulin [rabbit]), Zaltrap ® (ziv-aflibercept) a 

collaboration between Sanofi and Regeneron Pharmaceuticals, Inc. 

●● 

●● 

and

72 

To qualify for the free drug program: 

Household income for non-oncology 

products of

Seattle Genetics 

www.seagen.com 

Oncology-related products: Adcetris ® (brentuximab vedotin) 



www.seagensecure.com 


SeaGen Secure offers a Patient 

Assistance Program for uninsured and 

underinsured patients who have been 

prescribed Adcetris. Once an enrollment 

form (www.seagensecure.com/assets/ 

pdfs/3850_sgnmm_ fa1_ss_ form.pdf) has 

been completed, fax it to: 855.557.2480. 

It is important that each field is filled 

out completely and accurately to ensure 

timely processing of the application. 

If you have any questions, please call 

855.4SEAGEN (855.473.2436), option 1, 

to speak with a reimbursement counselor. 

Benefits Investigation 

Once the enrollment form is received, 

a benefits investigation is conducted to 

determine an individual patient’s coverage 

for treatment. It is our priority to 

make sure providers have patient-specific 

coverage information before starting 

patients on therapy with Adcetris, so 

we will fax providers a summary of 

the patient’s Adcetris-related benefits 

within two business days of receiving the 

completed request. If patient coverage for 

Adcetris is confirmed: 

●● 

●● 

Refer to sample claims form (http:// 

seagensecure.com/assets/pdfs/Sample_CMS_1500_ADCETRIS.pdf) 

for 

billing guidance. 

If the patient needs help paying coinsurance, 

he or she will be assessed 

for eligibility for the SeaGen Secure 

Co-Insurance Assistance Program 

or referred to an independent foundation. 

Note: To be eligible for the 

Co-insurance Assistance Program, 

patients must have coverage for 

Adcetris through a commercial 

insurer, be at least 18 years old, and 

be seeking treatment for a labeled 

indication. 

If patient does not have coverage for 

Adcetris: 

●● 

If the patient is insured, SeaGen 

Secure will assist with an appeal. If 

the appeal is unsuccessful, the patient 

will be assessed for eligibility for 

patient assistance. 

●● 

Skagit Valley Hospital Regional 

Cancer Care Center, Washington 

If the patient is uninsured, the patient 

will be assessed for eligibility for 

SeaGen Secure Assistance program. 

Co-Insurance Assistance 

SeaGen Secure offers an Adcetris 

Co-Insurance Assistance Program for 

commercially-insured patients who have 

trouble affording their co-insurance. 

Once an enrollment form has been completed, 

fax it to: 855.557.2480. It is important 

that each field is filled out completely 

and accurately to ensure timely processing 

of the application. 

If you have any questions, please call 

855.4SEAGEN (855.473.2436), option 1, 

to speak with a reimbursement counselor. 


SeaGen Secure reimbursement services 

include: 

●● 

Billing and coding support. Trained 

reimbursement counselors provide 

payer-specific billing and coding 

requirements to assist with the billing 

process. 

●● 

●● 

●● 

Prior authorization assistance. If it 

is determined that Adcetris treatment 

requires prior authorization, SeaGen 

Secure can determine which forms 

and processes are needed to secure 

the authorization. Additionally, Sea- 

Gen Secure can track the prior authorization 

claim once it is submitted. 

Appeal assistance and claims tracking. 

If an Adcetris prior authorization 

or claim is denied (or partially 

paid), SeaGen Secure will work to 

determine the reason for the denial 

and the steps for an appeal. SeaGen 

Secure will also provide a sample 

Letter of Medical Necessity (www. 

seagensecure.com/assets/pdfs/Adcetris_Sample_Letter_of 

_Medical_ 

Necessity_20120302.pdf). Medical 

Information may be able to assist with 

any additional data requests. After 

SeaGen Secure assists with an appeal 

and the documentation is submitted to 

the payer, we offer claims tracking to 

ensure the payer receives the appeal 

and addresses it. Claims tracking 

ensures that the provider is aware 

of claims payment and/or any payer 

delays in processing. 

General payer and policy research. 

Many payers have established 

Adecetris policies. SeaGen Secure 

can provide a copy of the requested 

policy or assist with navigating the 

Adcetris Payer Map. The Adcetris 

Payer Map allows providers to find 

payer policies based on their state and 

their patient’s specific payer. 

73 


TEVA Oncology 

formerly Cephalon Oncology 

www.tevausa.com 

Oncology-related therapeutic products: Treanda ® (bendamustine HCl) 

for Injection, Trisenox ® (arsenic trioxide) for Injection 

Oncology-related supportive care products: Actiq ® (oral transmucosal 

fentanyl citrate) [C-II], Fentora ® (fentanyl buccal tablet) [C-II] 

Oncology 



www.cephalononcologycore. 

com 


CORE Patient Assistance Program 

Cephalon supports patients and providers 

through programs for eligible patients 

treated in the United States who do not 

have insurance, cannot afford their outof-pocket 

co-pay costs, or need assistance 

with reimbursement issues. 

The CORE Patient Assistance Program 

provides FDA-approved products 

free of charge for patients who qualify. 

Cephalon also engages with groups like 

the Leukemia and Lymphoma Society 

that have programs designed to help 

patients access the treatments they need. 

For complete details and eligibility 

requirements, contact the CORE Hotline 

toll-free at 1.888.587.3263. 

●● 

●● 

●● 

is available online at: www. 

cephalononcologycore.com/includes/ 

pdf/Sample_Medical_TRISENOX.pdf. 

A sample letter of medical necessity 

for Treanda is available online at: 

www.cephalononcologycore.com/ 

includes/pdf/Sample_ 

Medical_TREANDA.pdf. 

Personalized support through the 

claims process. 

Requested information needed to support 

claims submission. 

Appeal support. A sample appeal 

When calling about patient-specific reimbursement 

issues, providers should have 

the following information available: 

●● 

●● 

●● 

Patient’s name, address, telephone 

number, date of birth, Social Security 

number, diagnosis, therapy start date, 

and expected course of treatment 

Name and telephone number of payer 

plan(s), policy number(s), and name of 

subscriber 

Provider’s name, address, and 

telephone number. 

For coverage verifications and prior 

authorization or appeal support, patients 

will need to review and sign a brief 

enrollment form and fax or mail it to the 

CORE Hotline. The enrollment form 

is online at: www.cephalononcologycore.com/includes/pdf/CORE_Enrollment_Form_20100930.pdf. 

When 


74 

CORE—Cephalon Oncology 

Reimbursement Expertise 

CORE is a convenient reimbursement 

resource that provides a support program 

along with online tools to help providers 

and patients better understand the 

reimbursement process. Reimbursement 

consultants provide assistance with the 

following: 

●● 

●● 

●● 

●● 

●● 

Benefit verification and coverage. 

Policy benefits and limitations. 

Pre-certifications. 

Drug and services coding information. 

Coverage guidelines and payer claim 

requirements. A sample letter of 

medical necessity for Trisenox 

letter for Trisenox is available online 

at: www.cephalononcologycore.com/ 

includes/pdf/Sample_Appeal_ 

TRISENOX.pdf. A sample appeal 

letter for Treanda is available online 

at: www.cephalononcologycore.com/ 

includes/pdf/Sample_Appeal_TRE- 

ANDA.pdf. 

Presbyterian Cancer 

Center, North Carolina 

complete, the form should be faxed to: 

1.866.676.4073 or mailed to: CORE, 

6900 College Blvd., Suite 1000, 

Overland Park, KS 66211. 

Reimbursement counselors are available 

by phone Monday through Friday, 

from 9:00 am to 8:00 pm EST. Simply 

call 1.888.587.3263. 

 


Other Patient Assistance Programs 

and Resources 

BenefitsCheckUp ® 

www.benefitscheckup.org 

BenefitsCheckUp is a free, confidential, 

online service of the National Council 

on Aging (NCOA). The online service 

will ask a series of questions to help 

adults over 55 who need help paying 

for prescription drugs, healthcare, utilities, 

and other basic needs and identify 

programs and benefits that could help. 

After answering the questions, patients 

will receive a personalized report that 

describes the programs or benefits that 

may offer support. Patients can apply 

for many of the programs online or 

print an application form. Here are 

the types of expenses patients may 

get help with: 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

Medications 

Food 

Utilities 

Legal 

Healthcare 

Housing 

In-home services 

Taxes 

Transportation 

Employment Training. 

If patients have Medicare and have 

limited income and resources, they may 

be able to get help paying for prescription 

drug costs if: 

●● 

●● 

Their income is less than $16,755 if 

single and $22,695 if married. If they 

live in Alaska or Hawaii, they may 

still get help even if their income is 

higher than these limits. 

Patients have resources less than 

$13,070 if single and $26,120 if 

married. 

If patients meet the guidelines, they 

will have low or no deductible, low or 

no premiums, no coverage gap (also 

called the “donut hole”), and will pay 

much less for their prescriptions. At 

the same time, patients can start the 

application process for the Medicare 

Savings Programs that could increase 

patients’ monthly income by $99.90. 

Patients will also find out if there are 

other benefit programs that can save 

them money. Apply online at: https:// 

www.benefitscheckup.org/cf/continue. 

cfm. For more information: www. 

benefitscheckup.org. 

Co-Pay Relief 

www.copays.org 

The Patient Advocate Foundation 

(PAF) Co-Pay Relief Program (CPR) 

provides direct financial support for 

pharmaceutical co-payments to insured 

patients, including Medicare Part D 

beneficiaries, who financially and 

medically qualify. 

The program offers innovative 

technology tools for patients, providers, 

and pharmacy representatives, including 

24-hour web-based application portals, 

electronic signature, document upload, 

and bar code fax routing capabilities, 

increasing the speed with which an 

approval can be granted and expenditures 

can be paid. The program also offers 

individualized service to all patients 

through the use of call counselors— 

personally guiding patients through the 

enrollment process. 

CPR currently assists insured patients 

who are financially and medically 

qualified and are being treated for the 

following: 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

●● 

Breast cancer 

Non-muscle invasive bladder cancer 

Non-small cell lung cancer 

Hormone suppression therapy 

Cutaneous t-cell lymphoma 

Multiple myeloma 

Myelodysplastic syndrome (and other 

pre-leukemia diseases) 

Renal cell carcinoma 

Pain. 

CPR offers a secured website for medical 

providers to enroll electronically for the 

CPR Program on behalf of their patients. 

Should you wish to access this provider 

resource, go to: www.copays.org/providers.php 

to obtain information on how 

to register and submit an application on 

your patient’s behalf. You will receive an 

email to confirm your registration and 

create your password. You will need to 

provide your provider tax Identification 

Number (EIN), National Provider Identifier 

(NPI), and a valid email address to 

complete the registration process. 

To register now go to: https://sx2035. 

unicentric.com/cprportal/ForProviders. 

aspx. If you have already registered with 

CPR, log in at: https://sx2035.unicentric. 

com/cprportal/Login.aspx to start the 

application process. 

Note: CPR provides assistance to patients 

on a first-come first-served basis and 

processes applicants in the order in which 

their completed applications are received. 

A thorough review of the completed 

application packet, in its entirety, is 

necessary before a final determination 

of acceptance for assistance can 

be made. Questions Contact CPR at: 

1.866.512.3861. 

HealthWell Foundation 

www.healthwellfoundation.org 

The HealthWell Foundation provides 

financial assistance to eligible individuals 

to cover coinsurance, co-payments, 

healthcare premiums, and deductibles for 

certain medications and therapies. If your 

patient has been prescribed a medication 

and his or her insurance company covers 

it, but the patient still cannot afford the 

co-insurance or co-payment required, 

HealthWell may be able to help by paying 

for part of the costs associated with the 

medication. Also, if your patient is eligible 

for health insurance, but cannot afford the 

insurance premium, HealthWell may be 

able to help with the insurance premium. 

Providers and patient advocates can 

apply on behalf of a patient in two ways: 

●● 

Apply online at: https://www.healthwellfoundationsupport.org/secure/ 

Default.aspx 

●● 

Apply by phone at: 800.675.8416. 

Before beginning the application process, 

please have the following information 

handy: 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

Patient contact information (name, 

address, telephone number, Social 

Security number, date of birth) 

Patient insurance and prescription 

information and ID (i.e., insurance 

and pharmacy card) 

Patient income information (total 

household income, total household 

size) 

Prescribing physician information 

(name, address, telephone number, 

fax number, contact name) 

Whether the patient is applying for 

co-payment or premium assistance. 

(Patients can receive only one or the 

other.). 

If the patient is pre-approved, providers 

75 


or advocates must submit the following 

required documentation within 30 days: 

✔✔ 

Complete Statement of Treatment 

with the prescribing provider’s 

signature. 

✔✔ 

✔✔ 

A copy of the patient’s insurance and 

pharmacy card(s), front and back. 

If requesting premium assistance, 

also include: documentation from the 

patient’s insurer or employer confirming 

the portion of the health insurance 

premium the patient is responsible 

for paying and documentation that 

the patient’s insurance will cover the 

medications for the disease state. We 

accept any of the following: 1) letter 

from insurer, Explanation of Benefits 

(EOB) form (must include patient 

name, insurer name, drug name, 

and co-pay amount), or 3) recent pharmacy 

receipt (must include patient 

name, insurer name, drug name, and 

co-pay amount). 

HealthWell must receive all the required 

documentation within 30 days of 

approval or the patient’s grant will 

be closed. The patient can re-apply, 

however, the approval date will reset. 

Dates of service and costs incurred prior 

to the most recent approval date will not 

be eligible for reimbursement. We will 

not call or send letters requesting any 

missing required documentation. It is the 

responsibility of the patient and provider 

to ensure we received the required documentation 

within 30 days of the approval. 

For fastest service, fax these items to 

HealthWell at: 800.282.7692. Providers or 

advocates will receive an automatic fax 

back confirmation, which includes the 

number of pages received. To check on 

the status of a grant, providers can register 

and use our secure online provider portal 

at: https://healthwellfoundation.secure. 

force.com. Providers can also use our 

automated system by calling: 800.675.8416 

and following the instructions. 

The Leukemia & 

Lymphoma Society 

www.lls.org 

The Leukemia & Lymphoma Society 

(LLS) Co-Pay Assistance Program helps 

patients pay their insurance premiums 

and meet co-pay obligations. LLS can 

also help providers and patients find 

additional sources of financial help. The 

LLS Co-Pay Assistance Program offers 

financial help toward: 

●● 

Cancer treatment-related co-pays 

●● 

Private health insurance premiums 

●● 

Private insurance co-pay obligations 

●● 

Medicare Part B, Medicare Part D, 

Medicare Supplementary Health 

Insurance, Medicare Advantage 

premium, Medicaid spend-down, or 

co-pay obligations. 

Prescription insurance coverage is 

required to qualify for this program. 

Prescription drugs covered under this 

76 

Sutter Cancer Center, California 

 


Financial Specialists as Part of the 

Multidisciplinary Cancer Care Team 

program include those supplied to the 

patient by a pharmacy or administered in 

an office or hospital by a healthcare provider. 

To receive assistance, patients must 

maintain insurance coverage at all times 

and the requested assistance must be 

covered by the patient’s insurance carrier. 

The program cannot provide financial 

assistance for drugs or treatments that are 

not included on the patient’s insurance 

plan or drug formulary. Providers must 

confirm the diagnosis and that the drugs 

or treatment received during doctor visits 

for which patients have applied for copay 

or premium assistance are being used 

to treat a blood cancer currently covered 

in LLS’s Co-Pay Assistance Program. 

To be eligible for Co-Pay Assistance, 

patients must: 

✔✔ 

✔✔ 

Have a household income at or within 

500 percent of the U.S. Federal 

Poverty Guidelines as adjusted by 

the Cost of Living Index (COLI). 

Reside in the United States or 

Puerto Rico and be medically 

✔✔ 

✔✔ 

and financially qualified 

Have prescription insurance coverage 

Have an LLS Co-Pay Programcovered 

blood cancer diagnosis 

confirmed by a provider. 

The following expenses are covered by 

the LLS Co-Pay Assistance program: 

●● 

Blood and marrow stem cell 

transplantation 

●● 

Blood cell boosters and 

erythropoietin-stimulating agents 

●● 

Blood transfusions 

●● 

Chemotherapy 

●● 

Intravenous preparation and/or 

maintenance procedures 

●● 

Iron chelation therapy 

●● 

Kyphoplasty 

●● 

Photopheresis and UV light therapy 

●● 

Prescription drug co-pays related 

to the covered co-pay diagnosis or 

treatment 

●● 

●● 

●● 


to incorporate this staff member and 

financial assistance services into your 

existing cancer care team. An experienced 

financial advocate explains how 

to develop a staffing model that will 

produce the best outcome for patients, 

providers, and program by: 

■■ 

■■ 

Clarifying and defining staff roles 

and responsibilities for providing 

financial assistance services to 

patients and families. 

Process mapping. Flow chart 

your financial assistance services 

and the staff that perform these 

functions. Look for ways to 

reduce duplication and improve 

or streamline your process. 

Public or private insurance premiums 

Radiation therapy 

Radioimmunotherapy. 

Apply online at: www.lls.org/#/diseaseinformation/getinformationsupport/financialmatters/copayassistance/ 

providers (providers) or www.lls.org/#/ 

diseaseinformation/getinformationsupport/financialmatters/copayassistance/ 

patients (patients). 

You can also apply or get more information 

about the LLS Co-Pay Assistance 

Program, by calling 877.557.2672 

and speaking with a co-pay specialist 

who will provide personalized service 

throughout the application process. 

■■ 

Explore models for how these 

staff members fit into an organizational 

chart. Who do these staff 

members report to How are they 

supervised How is job performance 

measured 





Needy Meds 

www.needymeds.org 

Patient assistance programs (PAPs) are 

usually sponsored by pharmaceutical 

companies and provide free or discounted 

medicines to low-to-moderateincome, 

uninsured, and underinsured 

people who meet the guidelines. Eligibility 

and application requirements vary 

from program to program. Here are four 

easy steps to find PAPs on this website: 

1. Search by name of the drug. PAPs are 

found by searching for the name of 

the medicine. 

2. Click on the Brand Name Drugs link 

at: www.needymeds.org/drug_list.taf. 

Click on the first letter of the drug’s 

name in the alphabet bar. An alphabetical 

listing of all the drugs offered 

through a PAP are listed. If it is not 

there, then click on the Generic Name 

Drugs link at: www.needymeds.org/ 

generic_list.taf and follow the same 

procedure. 

3. Click on the name of the medicine. 

This will open a program page with 

contact information, medication dosages, 

application if available, eligibility 

criteria, and other details of the PAP. 

4. Call the program. Please do not call 

NeedyMeds with specific program 

questions. Some programs will make 

exceptions to their eligibility criteria. 

The drugs offered and the program 

requirements change, so it may pay to 

call back from time to time. 

If your medicine is not on either list or 

77 


2013 Federal Poverty Guidelines 

78 

is not available through a PAP at this 

time go to: www.needymeds.org/indices/ 

cantfindmeds.htm. 

Providers and patients can also access 

other services, such as: 

●● 

●● 

Size of 

48 Contiguous 

Family Unit States and D.C. Alaska Hawaii 

1 $11,490 $14,350 $13,230 

2 $15,510 $19,380 $17,850 

3 $19,530 $24,410 $22,470 

4 $23,550 $29,440 $27,090 

5 $27,570 $34,470 $31,710 

6 $31,590 $39,500 $36,330 

7 $35,610 $44,530 $40,950 

8 $39,630 $49,560 $45,570 

For each additional 

person, add $4,020 $5,030 $4,620 

Source: Federal Register: January 24, 2013. 

Applications Assistance: www. 

needymeds.org/local_programs.taf. 

Many local programs and individuals 

assist providers and patients to 

use patient assistance programs. For 

a small fee, they can help with such 

things as finding a program, completing 

the forms, and working with 

physicians who must sign the forms. 

Click on your state to bring up a list 

of local programs. Click on the name 

of the program for more information. 

Diagnosis-Based Assistance: www. 

needymeds.org/copay_branch.taf. 

This database of programs helps 

with costs associated with specific 

diagnoses. They may cover many 

types of expenses, including drugs, 

insurance co-pays, office visits, 

transportation, nutrition, medical 

supplies, and child or respite care. 

Some cover one specific diagnosis, 

while others cover whole categories 

(such as all types of cancers) or 

even all chronic medical illnesses. 

These programs are funded by 

either private or government 

organizations. Some programs are 

national in scope, while others are 

limited to people in specific states. 

Most have some type of eligibility 

requirements, usually financial 

ones. It’s best to search by the type 

of diagnosis. Other ways to search 

for assistance are by looking for 

programs that serve a specific 

geographical area. Note that this 

method will only show programs 

●● 

that are limited to a state or region; 

national programs are not included 

in these lists. If you know the name 

of a specific program about which 

you want more information, you can 

also search by name of program. 

Assistance with Government 

Programs: www.needymeds.org/ 

indices/government_programs.htm. 

Every state has programs to help 

needy families and individuals with 

the cost of healthcare. NeedyMeds 

has compiled a database of these 

State Programs. The programs can 

be found by clicking on a state, the 

District of Columbia, Puerto Rico, or 

Guam. Programs and their guidelines 

vary from state to state. NeedyMeds 

also has a list of Medicaid Sites: www. 

needymeds.org/indices/medicaid. 

htm. Other helpful links include the 

Federal Poverty Guidelines: www. 

needymeds.org/indices/povertyguidelines.htm, 

and a Tax Return Request 

Form: www.needymeds.org/indices/ 

forms.htm. 

At this time, NeedyMeds.org does not 

have a phone helpline. All NeedyMeds 

information is available on its website. 

Providers or patients who need help 

using the website can email: info@ 

needymeds.com. 

Partnership for 

Prescription Assistance 

www.pparx.org 

The Partnership for Prescription Assistance 

(PPA) helps qualifying patients 

without prescription drug coverage 

receive the medicines they need for 

free or nearly free. PPA offers a single 

point of access to more than 475 public 

and private programs, including nearly 

200 pharmaceutical patient assistance 

programs. To learn more, download the 

brochure at: www.pparx.org/sites/default/ 

files/PPA_brochure.pdf. 

Here’s how PPA works: 

●● 

●● 

●● 

●● 

●● 

Step 1: Tell us what medicines your 

patient takes. Go to: www.pparx.org/ 

en/gethelp/select-meds to search for 

and pick out the medicines. Type the 

name of the medicine into the box 

and click the search button. Once 

the search is complete you can add 

one or more prescription drugs from 

your search to the My Medicines list, 

which appears on the right side of the 

page. Repeat this process until you 

have entered and selected all of the 

medicines. 

Step 2: Tell us about your patient. 

Provide basic information about the 

patient and the type of drug coverage 

(if any) he or she currently has. 

Answer short questions, such as the 

patient’s residency, age, and household 

income, to see which patient 

assistance programs the patient 

may qualify for. You must answer 

all questions on this page for your 

patient to be considered. If you need 

assistance, please call 1.888.477.2669 

Monday through Friday, from 9:00 

am to 5:00 pm EST. 

Step 3: Get your results. See which 

prescription assistance programs 

your patient may be eligible for and 

select the ones you would like to 

apply to. 

Step 4: Complete the application process. 

Print, complete, and mail your 

applications to each program you are 

applying to. 

PPA offers other resources, including: 

A list of co-pay programs at: www. 

pparx.org/en/prescription_assistance_programs/co-payment_programs. 

●● 

●● 

A list of discount drug card 

programs at: https://www.pparx.org/ 

en/prescription_assistance_programs/discount_cards. 

Information about Medicare drug 

coverage at: https://www.pparx.org/ 

en/prescription_assistance_programs/medicare_drug_coverage. 

 


Patient Access Network 

Foundation 

www.panfoundation.org/ 

PAN is an independent non-profit organization 

that provides assistance to underinsured 

patients for their out-of-pocket 

expenses for life-saving medications. 

Providers and their patients can apply for 

assistance by calling: 1.866.316.7263 or 

start the application online at: www. 

panfoundation.org/fundingapplication/ 

index.php9. 

In order for patients to qualify for 

co-payment assistance with the Patient 

Access Network Foundation, they must 

meet the following eligibility criteria: 

Patient is insured and insurance 

covers the medication for which the 

patient seeks assistance 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

The medication must treat the disease 

directly 

Patient’s income must be below a 

designated percentage of the Federal 

Poverty Level, depending on individual 

fund requirements 

Patient is prescribed a high-cost drug 

for the disease, depending on individual 

fund requirements 

Patient must reside and receive treatment 

in the U.S. 

Patients applying for financial assistance 

for their co-payments need to have access 

to the following information: 

✔✔ 

Step 1. Select the disease for which 

you are seeking assistance, the 

patient’s insurance type, and the 

medication(s). If the patient is commercially 

insured and has selected 

a medication for which the manufacturer 

program has a co-pay card 

program, you will be made aware 

under the alternative programs box. 

Please research these other programs 

as manufacturer programs may be 

more generous than what PAN has 

to offer. 

✔✔ 

Center for Cancer Care 

& Research, Florida 

tion.org or 202.347.9273 for more 

information. 

Step 3. You will need to have access 

to the following information for the 

patient: 

Demographic Information 

■■ 

First and last name 

■■ 

Social Security number or Alien 

Number 

■■ 

Date of birth 

■■ 

Gender and marital status 

■■ 

Employment status 

■■ 

Phone number 

■■ 

Street address and email address 

■■ 

Language the patient speaks and 

understands 

■■ 

Residency status. 

Income Information 

■■ 

Number of people in the household 

■■ 

Income received from wages, 

tips, or salaries 

■■ 

Income from IRA distributions, 

pensions, or annuities 

■■ 

Social Security benefits, including 

the amount of the benefits 

received 

■■ 

Any other income (child support, 

alimony, rental income, etc.). 

✔✔ 

✔✔ 

■■ 

■■ 

insurance for his or her medications 

Does the patient receive assistance 

from any other co-pay or 

co-insurance assistance organizations 

How did the provider or patient 

first hear about the Patient Access 

Network 

Step 4. You will need to access to 

the following information for the 

provider: 

■■ 

■■ 

■■ 

■■ 

■■ 

■■ 

First name 

Last name 

Phone number 

Fax number 

Email 

Address. 

Step 5. Review the application to 

make sure the information entered is 

correct and then submit the application 

online at: www.panfoundation. 

org/fundingapplication/patientEnrollment.php. 

Applications and supporting 

documents can also be mailed to: 

PAN Foundation, PO Box 221858, 

Charlotte, NC 28222-1858 or faxed 

toll-free to: 1.866.316.7261. 

✔✔ 

Step 2. You will need to select the use 

type. As a provider, click the “I am 

applying for someone else” box. If the 

patient is applying, he or she will click 

the box “I am applying for myself.” 

If you are from a specialty pharmacy, 

you will need to undergo training 

with the PAN Foundation. Contact 

Korab Zuka at: kzuka@panfounda- 

Insurance and Co-payment 

Information 

■■ 

Primary insurance carrier 

■■ 

Policy ID number 

■■ 

Group number 

■■ 

Telephone number 

■■ 

Secondary insurance carrier 

and contact information 

■■ 

What is the patient’s co-pay or co- 

Patient Advocate 

Foundation 

www.patientadvocate.org 

The Patient Advocate Foundation 

(PAF) is a national non-profit organization 

that serves as an active liaison 

between the patient and his or her 

79 


80 

insurer, employer, and/or creditors to 

resolve insurance, job retention, and/ 

or debt crisis matters relative to the 

patient’s diagnosis through case managers, 

physicians, and attorneys. PAF 

seeks to safeguard patients through 

effective mediation, assuring access to 

care, maintenance of employment, and 

preservation of their financial stability. 

PAF offers services by telephone, 

email, or web chat to patients in need 

that fall under the scope of our services. 

Our professional staff members 

intervene by making conference calls 

when needed, assisting with appeals 

to insurance companies or the Social 

Security Administration, negotiating 

with providers in medical debt situations, 

or securing access to care. Our 

staff strives for positive resolutions 

whenever possible and provides the 

following services: 

●● 

●● 

●● 

●● 

●● 

Case Management 

Co-Pay Relief 

MedCareLine 

Outreach 

Prevention Resources. 

PAF’s Patient Services provides patients 

with arbitration, mediation, and negotiation 

to settle issues with access to care, 

medical debt, and job retention related to 

their illness. Assistance is available in the 

following areas: 

Access to Care. PAF offers direct 

guidance for patients seeking access to 

pharmaceutical agents (drugs), devices 

that help with certain functions as medically 

necessary, and procedures, such 

as surgeries. Frequently, insurers deny 

these types of requests because certain 

conditions are usually not met. PAF’s 

professional case managers will be the 

liaison between you and the insurer (your 

insurance plan or policy) to ensure that 

you are getting the very best possible 

care and access according to your policy. 

Financial Assistance. PAF has developed 

a list of resources for patients 

seeking assistance with accessing their 

medications or help with the out-ofpocket 

expenses for their medications. 

Prescription assistance programs that 

cater to uninsured or underinsured 

patients can be found at: www.patientadvocate.org/index.phpp=775. 

Other 

financial services include assistance 

with: the disability process, the medical 

debt crisis, and co-pay assistance. 

Insurance Assistance. PAF offers assistance 

with the following patient issues: 

●● 

Insurance appeals process 

●● 

Pre-authorization(s) 

●● 

Coding and billing 

●● 

Debt crisis assistance 

●● 

Medicare and Medicaid 

●● 

Clinical trial barriers. 

Job Retention Assistance. PAF case 

managers help patients with issues 

regarding reasonable accommodation in 

the workplace (in accordance with the 

Americans with Disabilities Act of 1990). 

Case managers also serve as a liaison 

between patients and employers for 

issues related to FMLA and help assist 

with employment rights for disabled 

individuals. Patient Advocate Foundation 

case managers make referrals to 

the EEOC for patients who feel they are 

being discriminated against and desire to 

file a formal complaint. 

Questions Contact the Patient Advocate 

Foundation at: help@patientadvocate. 

org or call: 800.532.5274. 

RxAssist 

www.rxassist.org 

The RxAssist database contains eligibility 

information and applications for 

more than 150 pharmaceutical company 

patient assistance programs. The 

database can help you find out whether a 

drug is available, which pharmaceutical 

company program offers the drug, and 

how to apply for the medication. In order 

to use the database, you must register 

either as a provider or patient. 

Using RxAssist 

Step 1: Go to www.rxassist.org and 

click “Learn More” under either the 

Provider Center or Patient Center. 

✔✔ 

✔✔ 

✔✔ 

Step 2: In the database search box, 

type in either the drug name or company 

name. If you would like to search 

for multiple drugs, click the advance 

search button. Then, enter the items in 

the search boxes that pop up. 

Step 3: After you have entered 

information in the search box, if the 

✔✔ 

✔✔ 

✔✔ 

database finds a match, a Search 

Results page will appear. (If there 

is only one program available for a 

medication, you will be taken directly 

to the Program Details page.) 

Step 4: Click the underlined hyperlink 

of the medication you want in the 

Search Results page, and you will be 

taken to the Program Details page. 

Step 5: The Program Details page 

includes eligibility criteria and 

information on how to apply to the 

program. If an application is available 

for a program, you will see “Application 

Forms and Instructions” to 

the right with links to download the 

application. 

Step 6: If an application is available 

online, you can either open (download) 

the application, type information 

directly onto the application on 

the screen and print it out, or print out 

the application and fill it out by hand. 

If there is no application online, use 

the phone number provided at the top 

of the Program Details page to call 

the company for information on how 

to get an application. 

The RxAssist Learning Center is where 

healthcare advocates and safety net 

providers find the information they need 

to manage the challenges of our changing 

healthcare world. If you are a provider 

working with patients with chronic diseases 

and medication assistance needs, 

the Learning Center offers the following 

resources: 

●● 

●● 

●● 

●● 

●● 

Browse the library of carefullyselected 

resources related to medication 

assistance, healthcare access, 

patient resources, and program tools. 

Read healthcare reform highlights. 

Explore virtual learning with 

webinars. Webinars are hosted by 

RxAssist staff, include guest speakers 

and welcome audience participation. 

Webinars are free, but registration is 

required. 

Join RxConnects, a listserv discussing 

issues related to medication 

access. 

Join RxUpdates to receive regular 

notification of changes in pharmaceutical 

company and other medication 


Questions Contact RxAssist at: info@ 

rxassist.org. 

 


RxHope 

www.rxhope.com 

Here’s how this web-based patient 

assistance program works. The provider 

enters the site and clicks on the 

Patient Assistance Application link. 

Providers then choose from the available 

products, fill in the application, 

and depending on the manufacturer, 

either print and fax the application 

for signature verification or mail the 

printed application to the appropriate 

address. Some products do not require 

a fax or mail; they may be completed 

electronically. All information is sent 

to the pharmaceutical manufacturer for 

final approval and shipping. 

Healthcare providers and their staff 

can set up accounts online to order free 

medications for their patients through 

our automated patient assistance online 

system. If you would like to create a 

free account for one healthcare provider, 

please read the instructions below. If 

you would like to create a free account 

for multiple healthcare providers, call 

RxHope at 1.877.267.0517 and a customer 

service representative will 

assist you. 

To set up your free account and place 

orders online for individual and multiple 

provider accounts, the following criteria 

is required: 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

✔✔ 

You must be a healthcare provider or 

their staff 

A valid state license number for the 

healthcare provider 

An email address (this will become 

your login) 

The medication for which the patient 

is applying 

The patient’s first and last name. 

Once you have the above information 

available, go to: www.rxhope.com/ 

Prescriber/Register.aspx and follow the 

instructions. You will be setting up your 

free account and creating an order for 

your patient all at the same time. 

RxHope provides this service to 

physicians and patients free of charge. 

RxHope is available to assist providers 

and patients Monday through Friday, 

from 8:00 am to 7:00 pm EST by calling 

1.877.267.0517. You can also contact 

RxHope by emailing: CustomerService@RxHope.com. 

Rx Outreach ® 

www.rxoutreach.org 

Patients can use Rx Outreach regardless 

of age or if they use another discount 

medicine program or patient assistance 

program. To use Rx Outreach, the 

patient’s income needs to be less than a 

certain amount of money each year. This 

amount differs, depending on the number 

of financially dependent people living in 

the house: 

●● 

●● 

●● 

●● 

●● 

1-person household: Less than 

$33,510/year. (Alaska: less than 

$41,910/year; Hawaii: less than 

$38,580/year). 


$45, 390/year. (Alaska: less than 


$52,530/year). 




$65,880/year). 




$79,530/year). 

More than 4-person household: For 

each additional person in the house, 

add $11,880/year. (Alaska: add 

$14,850/year; Hawaii: add $13,650/ 

year). For example, if six people 

are in the household, the patient’s 

income must be less than $92,910 a 

year ($69,150 + $11,880 + $11,880 = 

$92,910). 

Providers and patients can enroll in the 

program by following these four steps: 

✔✔ 

Determine patient eligibility using 

criteria above. 

✔✔ 

See if the patient’s drug is listed on 

the RxOutreach Medication’s List: 

www.rxoutreach.org/medications. 

✔✔ 

✔✔ 

Obtain a prescription from the provider. 

Prescriptions may be written 

with refills available for up to one 

year. Ask your doctor about a 180-day 

supply with one refill or a 90-day supply 

with three refills. 

Create a simple web account then 

enroll/re-enroll online at: https:// 

remote.rxoutreach.org/login/auth;jse 

ssionid=30465B636751F923960A6B1 

BA8F99C2F. 

Completed applications, along with 

your prescription and payment, can be 

mailed to: Rx Outreach, PO Box 66536, 

St. Louis, MO, 63166-6536. For more 

information, go to: www.rxoutreach.org 

or call 1-800.769.3880, Monday through 

Friday, 7:00 am to 5:30 pm CST. 

Together Rx Access ® 

Card 

www.togetherrxacess.com 

To qualify for a Together Rx Access 

Card, individuals must: 

●● 

Not be eligible for Medicare 

●● 

Have no prescription drug coverage 

of any kind 

●● 

Have a household income that is 

equal to or less than: $45,000 for a 

single person; $60,000 for a family 

of two; $75,000 for a family of 

three; $90,000 for a family of four; 

$105,000 for a family of five. (Families 

of six or more and residents of 

Alaska and Hawaii should contact 

the Together Rx Access Program at: 

1.800.444.4106.) 

Applying for the Together Rx Access 

Card is free and takes just a few minutes. 

Patients may apply: 

●● 

●● 

●● 

Online using the checklist at: 

www.togetherrxaccess.com/p/ 

prescription-savings/about-togetherrx-access/enroll.aspx. 

By downloading, printing, and filling 

out the application at: www.togetherrxaccess.com/App_Controls/Enrollment/pdf/TRx_Access_Enroll_English.pdf. 

The completed application 

should be mailed to: Together Rx 

Access, LLC, P.O. Box 9426, Wilmington, 

DE 19809-9944. 

Over the phone by calling: 

1.800.444.4106. 

Patients who enroll online or by phone 

can use their member ID number at 

participating pharmacies within two 

hours of enrollment. To use the card, 

patients show it to their pharmacists 

when purchasing brand-name prescription 

medicines. Savings on generic drugs 

are also available and vary by pharmacy. 

Participating pharmacies can be found 

online at: www.togetherrxaccess.com/p/ 

prescription-savings/about-together-rxaccess/pharmacies.aspx. 

81 



gratefully acknowledges its 2013 

Industry Advisory Council 

Amgen, Inc. 

Astellas Pharmaceuticals 

Bayer Healthcare 

Bristol-Myers Squibb 

Celgene Corporation 

Eisai 

Eli Lilly and Company 

Genentech, Inc. 

GlaxoSmithKline 

Janssen Biotech 

Merck 

Millennium 

Novartis 

Pfizer Oncology 

sanofi-aventis 

TEVA Oncology 

Emerging Companies Council 

Ariad Pharmaceuticals 

Boehringer Ingelheim 

EMD Serono 

Genomic Health 

Onyx Pharmaceuticals 

Seattle Genetics 

Technical Advisory Council 

ION Solutions 

Philips Healthcare 

Veridex 

for their support. 

We want to hear from ACCC members. If your community cancer center knows of any 

additional patient assistance programs or you have suggestions for improving this guide 

for 2014, please contact us. If you know of any changes to an existing patient assistance 

program and/or reimbursement program or find an incorrect form or broken link in this 

publication, please let us know. Email all comments and feedback to ACCC’s managing 

editor at: mmarino@accc-cancer.org. 

Managing Editor: Monique J. Marino, Associate Editors: Jillian Kornak, Amanda Patton, Designer: Constance D. Dillman 

Cover Photograph courtesy of The Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital, Florida. 

82 

©2013. Association of Community Cancer Centers. Although every effort has been made to ensure the accuracy and completeness of this guide, 

ACCC is not responsible for any errors or omissions contained within. Inclusion of companies within this publication does not serve as 

an endorsement by ACCC of the company, its products, or its services. 

 


Association of Community Cancer Centers 

11600 Nebel Street, Suite 201 

Rockville, MD 20852 

www.accc-cancer.org 

Phone: 301.984.9496 

Fax: 301.770.1949

2013 Patient Assistance and Reimbursement Guide - Association of ...

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