Drug: ACCUTANE - Magellan Health Services || TennCare Portal

Proposed 

Preferred Drug List 

with 

Clinical Criteria 

Proposal for TennCare 

August 13, 2013 

Page 1 of 14 

August 13, 2013 Tennessee PAC

Responsibilities of the TennCare Pharmacy Advisory Committee 

Source: Tennessee Code/Title 71 Welfare/Chapter 5 Programs and Services for Poor 

Persons/Part 24 Tennessee TennCare Pharmacy Advisory Committee/71-5-2401 through 71-5- 

2404. 

 

 

 

Make recommendations regarding a preferred drug list (PDL) to govern all state expenditures 

for prescription drugs for the TennCare program. 

o The TennCare Pharmacy Advisory Committee shall submit to the bureau of 

TennCare both specific and general recommendations for drugs to be included on 

any state PDL adopted by the bureau. In making its recommendations, the 

committee shall consider factors including, but not limited to, efficacy, the use of 

generic drugs and therapeutic equivalent drugs, and cost information related to each 

drug. The committee shall also submit recommendations to the bureau regarding 

computerized, voice, and written prior authorization, including prior authorization 

criteria and step therapy. 

o The state TennCare pharmacy advisory committee shall include evidence-based 

research in making its recommendations for drugs to be included on the PDL. 

o The TennCare bureau shall consider the recommendations of the state TennCare 

pharmacy advisory committee in amending or revising any PDL adopted by the 

bureau to apply to pharmacy expenditures within the TennCare program. The 

recommendations of the committee are advisory only and the bureau may adopt or 

amend a PDL regardless of whether it has received any recommendations from the 

committee. It is the legislative intent that, insofar as practical, the TennCare bureau 

shall have the benefit of the committee’s recommendations prior to implementing a 

PDL or portions thereof. 

Keep minutes of all meetings including votes on all recommendations regarding drugs to be 

included on the state preferred drug list 

The chair may request that other physicians, pharmacists, faculty members of institutions of 

higher learning, or medical experts who participate in various subspecialties act as 

consultants to the committee as needed. 

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PDL Decision Process 

The primary clinical decision that needs to be made is determining if the drugs within the 

therapeutic class of interest can be considered therapeutic alternatives. 

A Therapeutic Alternative is defined by the AMA as: “drug products with different chemical 

structures but which are of the same pharmacological and/or therapeutic class, and usually 

can be expected to have similar therapeutic effects and adverse reaction profiles when 

administered to patients in therapeutically equivalent doses” 1 . 

The Committee should not feel obligated to decide if every drug within the therapeutic class is 

exactly equal to all other drugs within the class, nor should they feel obligated to decide if 

every drug within the therapeutic class works equally well in every special patient population 

or in every disease. 

In special situations (e.g., presence of comorbid conditions) and in special populations (e.g., 

pediatrics) use of a non-preferred drug might be the most appropriate therapy. These cases 

can be handled through prior authorization (PA). PA serves as a “safety valve” in that it 

facilitates use of the most appropriate agent regardless of PDL status. 

LENGTH OF AUTHORIZATIONS: Dependent upon diagnosis and length of therapy needed 

to treat. (Most medications are used chronically, and thus would be approved for 1 year.) 

1. Is there any reason the patient cannot be changed to a medication not requiring prior 

approval within the same class 

Acceptable reasons include: 

• Allergy to medications not requiring prior approval 

• Contraindication to or drug-to-drug interaction with medications not requiring prior 

approval 

• History of unacceptable/toxic side effects to medications not requiring prior approval 

2. The requested medication may be approved if both of the following are true: 

• If there has been a therapeutic failure of at least two medications within the same 

class not requiring prior approval (unless otherwise specified) 

• The requested medication’s corresponding generic (if a generic is available and 

preferred by the State) has been attempted and failed or is contraindicated 

3. The requested medication may be approved if the following is true: 

• An indication which is unique to a non-preferred agent and is supported by 

peer-reviewed literature or an FDA approved indication exists. 

----------------------------------------------------------------------------------------------------------------------------- --- 

The information provided for each drug class is organized into the following sections, when 

applicable: 

BACKGROUND: 

General overview 

Pharmacology 

Therapeutic effect(s) 

Adverse reactions 

Outcomes data 

Place in therapy according to current Treatment Guidelines 

RECOMMENDATION: 

General recommendation regarding utility and therapeutic equivalence among the agents 

in the class, as well as requirements for product availability (PDL placement) 

1 AMA Policy H-125.991 Drug Formularies and Therapeutic Interchange 

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BACKGROUND 

ENDOCRINE & METABOLIC AGENTS 

NEW: SODIUM-GLUCOSE CO-TRANSPORTER-2 (SGLT2) INHIBITOR 

 

 

 

 

Canagliflozin (Invokana) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. SGLT2 

is the transporter responsible for reabsorbing the majority of glucose filtered by the 

tubular lumen in the kidney. SGLT2 is expressed in the proximal renal tubules. By 

inhibiting SGLT2, canagliflozin reduces reabsorption of filtered glucose and lowers the 

renal threshold for glucose (RTG), and thereby increases urinary glucose excretion, 

improving blood glucose control. 

Canagliflozin is FDA-approved as as an adjunct to diet and exercise to improve glycemic 

control in adults with type 2 diabetes mellitus. Canagliflozin is not indicated for type 1 

diabetes or diabetic ketoacidosis. 

The most common adverse effects seen in clinical trials were genital mycotic infections, 

urinary tract infections, increased urination, vulvovaginal pruritis, thirst, constipation, 

nausea and abdominal pain. Other adverse effects include: asthenia, fatigue, acute or 

chronic pancreatitis, bone fracture, hypersensitivity reactions, photosensitivity, and 

volume depletion. 

o Canagliflozin is contraindicated in patients with severe renal impairment 

[estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m 2 ], end 

stage renal disease (ESRD), and in patients on dialysis. 

o Precautions: 

• Symptomatic hypotension can occur after starting canagliflozin as it 

causes intravascular volume contraction. Symptomatic hypotension 

occurs particularly in patients with impaired renal function (eGFR less 

than 60 mL/min/1.73 m 2 ), elderly patients, patients with low systolic blood 

pressure, and patients on diuretics or drugs which interfere with the 

renin-angiotensin-aldosterone system. 

• Canagliflozin can cause hyperkalemia. Patients with moderate renal 

impairment who are also taking medications that interfere with potassium 

excretion or the renin-angiotensin-aldosterone system are more 

susceptible to the development of hyperkalemia. 

• Canagliflozin may cause dose-related increases in low-densitylipoprotein 

cholesterol (LDL-C). 

• Canagliflozin is Pregnancy Category C. 

o Drug-Drug Interactions: 

• When administered with UDP-Glucuronosyl Transferase (UGT) enzyme 

inducers (e.g. rifampin, phenytoin, ritonavir, phenobarbital) the exposure 

of canagliflozin is reduced which may decrease the efficacy of 

canagliflozin. 

• Co-administration of digoxin and canagliflozin may increase the 

exposure to digoxin. 

Clinical Trials 

o 

A 26 week, double-blind, placebo- and active-controlled study was performed in 

1,284 patients with type 2 diabetes who were inadequately controlled on 

metformin monotherapy (greater than or equal to 2,000 mg/day, or at least 1,500 

mg/day if higher dose not tolerated) to assess the safety and efficacy of 

canagliflozin when combined with metformin. If patients were taking less than 

the required metformin dose or were taking metformin plus another 

antihyperglycemic (n=275) they were switched to metformin monotherapy for at 

least eight weeks before they were allowed to enter the two week, single-blind, 

placebo run-in. Patients who were already taking the required metformin dose 

(n=1,009) were immediately allowed to enter a two-week, single-blind, placebo 

run-in period. After completing the placebo run-in phase, patients were 

randomized to receive canagliflozin 100 mg, canagliflozin 300 mg, sitagliptin 100 

mg, or placebo once daily with metformin. The study indicated that canagliflozin 

100 mg and canagliflozin 300 mg once daily with metformin resulted in 

statistically significant improvements in HbA 1 C compared to placebo with 

Page 4 of 14 



 

metformin (-0.79, -0.94, -0.17, p


RECOMMENDATION 

Canagliflozin is currently the only available sodium-glucose co-transporter 2 (SGLT2) inhibitor and 

is FDA-approved as an adjunct to diet and exercise to improve glycemic control in adults with type 

2 diabetes mellitus. While results from clinical trials demonstrate that canagliflozin is an efficacious 

agent in reducing HbA 1 C, PPG, and FPG, this agent is also associated with a number of adverse 

effects. The 2013 guidelines from the AACE suggest SGLT-2 inhibitors as a fifth, fourth, and third 

choice in monotherapy, dual therapy, and triple therapy, respectively for glycemic control. The 

guidelines also warn prescribers to use SGLT-2 inhibitors with caution as there are other 

antihyperglycemic agents with fewer adverse events and/or even possible benefits. Due to the 

fact that SGLT-2 inhibitors are not considered first line therapy and other antihyperglycemic agents 

are available with fewer adverse events, it is recommended that SGLT-2 inhibitors should be 

subject to prior authorization. 

COMMITTEE VOTE: 

APPROVED DISAPPROVED APPROVED with MODIFICATION 

PREFERRED 

N/A 

NEW: SGLT2 INHIBITOR 

NON-PREFERRED 

® PA, QL 

INVOKANA 

Class Prior Authorization Criteria for SGLT2 INHIBITORS 

Will be approved if ALL of the following are true: 

Diagnosis of Diabetes Type II, AND 

Patient’s HbA1c level is greater than 6.5 (for initial approval), AND 

Patient has tried and failed metformin or a metformin containing product (unless, recipient 

has an adverse reaction, intolerance or contraindication to metformin), AND 

Patient has tried and failed at least ONE agent from any 2 of the following classes: 

o DPP4 Inhibitor 

o Sulfonylurea 

o Incretin Mimetic 

o Insulin 

o TZD 

o Alpha-glucosidase inhibitor 

o Meglitinide 



Quantity Limits 

Invokana ® 

1/day 



References 

1. Facts and Comparisons on-line. Version 4.0; Wolters Kluwer Health, Inc.; 2013. 

Accessed July, 2013. 

2. Thompson MICROMEDEX on-line © 1974-2013. Accessed July, 2013. 

3. Magellan Medicaid Administration. Invokana New Drug Update. April, 2013. 

4. Invokana [package insert]. Titusville, NJ; Janssen Pharmaceuticals; March 2013. 

5. American Association of Clinical Endocrinologists. AACE Comprehensive Diabetes 

Management Algorithm. Endocrine Practice. 2013; 19(2): 327-336. Available at: 

http://aace.metapress.com/content/a38267720403k242/p=def7091b7a8144b4905138a3 

539d2ce5&pi=21. Accessed May 16, 2013. 

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GASTROINTESTINAL AGENTS 

BACKGROUND 

 

 

 

 

NEW: DICLEGIS 

Doxylamine succinate/pyridoxine HCL is a fixed combination of an anticholinergic 

antihistamine and a vitamin B6 analog indicated for the treatment of nausea and 

vomiting of pregnancy in women who do not respond to conservative 

management. 

The most common adverse effect occurring in ≥ five percent of patients reported 

was somnolence (14.3 percent). In post marketing, adverse effects that occurred 

include dyspnea, palpitations, tachycardia, vertigo visual disturbances, 

abdominal distension, anxiety, dysuria and rash. 

o Due to the anticholinergic antihistamine component it is not 

recommended to be used with central nervous system depressants 

including alcohol and should be used with caution in patients with asthma, 

increased intraocular pressure, narrow angle glaucoma, stenosing peptic 

ulcer, pyloroduodenal obstruction and urinary bladder-neck obstruction. 

o An extended anticholinergic effect may occur with concurrent use of an 

MOA inhibitor and doxylamine therefore it is not recommended. It should 

also not be administered with alcohol or other central nervous system 

(CNS) depressants. 

Nausea and vomiting of pregnancy symptoms was evaluated in a randomized, 

multicenter, double blind, placebo controlled study. With an intent to treat, the 

symptoms of a total of 256 pregnant patients, 18 years and older, with a seven to 

14 week gestation (median nine weeks of gestation) were randomized to receive 

Diclegis (n=131) or placebo (n=125) for 14 days. Nausea and vomiting symptoms 

were evaluated daily using the pregnancy unique quantification of emesis 

(PUQE) scale with the primary efficacy endpoint being measured from baseline 

to Day 15. At baseline, the mean PUQE score was 9 for Diclegis patients and 

8.8 for placebo patients. On Day 15, Diclegis demonstrated a 0.7 mean 

decrease in PUQE score compared to placebo (–4.8 ± 2.7 versus –3.9 ± 2.6; 

p=0.006). 

According to the American College of Obstetrician and Gynecologist (ACOG) and 

Association of Professors of Gynecology and Obstetrics, the treatment of nausea 

and vomiting of pregnancy also referred to as morning sickness with pyridoxine 

and vitamin B6 or vitamin B6 have been first-line recommendations for many 

years. Diclegis is the first FDA-approved, pregnancy category A delayed-release 

combination medication for the treatment of nausea and vomiting of pregnancy. 


Doxylamine succinate/pyridoxine HCL is a fixed combination of an anticholinergic 

antihistamine and a vitamin B6 analog indicated for the treatment of nausea and vomiting 

of pregnancy in women who do not respond to conservative management. ACOG 

guidelines consider pyridoxine and vitamin B6 among the first-line recommendations for 

the treatment of nausea and vomiting of pregnancy. Therefore, it is recommended 

doxylamine succinate/pyridoxine should be available for the treatment of nausea and 

vomiting in pregnancy. 



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GASTROINTESTINAL AGENTS 

PREFERRED 

N/A 

NEW: DICLEGIS 

NON-PREFERRED 

DICLEGIS ® (doxylamine succinate/pyridoxine) 

Prior Authorization Criteria 

Diclegis will be approved for pregnant females. 




Diclegis ® 

4/day 



References 




3. Magellan Medicaid Administration. Diclegis New Drug Update. May, 2013. 

4. Koren G, Clark S, Hankins GDV, et al. Effectiveness of delayed-release doxylamine and 

pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. 

Am J Obstet Gynecol. 2010; 203(6):571.e1-7. Available at: 

http://download.journals.elsevierhealth.com/pdfs/journals/0002- 

9378/PIIS0002937810009142.main-abr.pdfjid=ymob. Accessed May 29, 2013. 

5. American College of Obstetricians and Gynecologists. Nausea and vomiting of pregnancy. 

ACOG Practice Bulletin No. 52. Obstet Gynecol. 2004; 103:803-15. Available at: 

http://www.molinahealthcare.com/medicaid/providers/mo/pdf/acog%20nausea%20%20vo 

miting%20pregnancy.pdfE=true. Accessed May 29, 2013. 

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OPHTHALMIC AGENTS 

NEW: CYSTARAN 

BACKGROUND 

 

 

 

Cystinosis is a rare genetic metabolic disease affecting an estimated 2,000 individuals 

worldwide. Cystinosis causes accumulation of the amino acid in multiple organs of the 

body and without specific treatment patients typically develop end stage renal disease 

around the age of nine years. Excess cystine damages cells and commonly results in 

crystalline cystine formation that builds up in many tissues and organs causing significant 

issues. Eyes and kidneys are particularly vulnerable to cystine accumulation and 

damage; however, muscles, thyroid, pancreas and testes may also be affected. 

Cysteamine decreases the amount of cystine in the lysosomes of patients with cystinosis. 

Exogenous cysteamine enters the cell and converts cystine to cysteine and a cysteinecysteamine 

complex. Both cysteine and the cysteine-cysteamine complex are more 

readily transported out of the lysosome than cystine, resulting in a long-term depletion of 

lysosomal cystine. 

Ophthalmic cysteamine is indicated for use in the treatment of corneal cystine crystal 

accumulation in patients with the genetic disease cystinosis. 

In ophthalmic cysteamine clinical trials, the most commonly reported adverse reactions (≥ 

ten percent) reported by patients were sensitivity to light, redness, eye pain/irritation, 

headache and visual field defects. 

 

 

o 

o 

There are no reported contraindications to ophthalmic cysteamine. 

Instances of benign intracranial hypertension (or pseudotumor cerebri) have 

been reported in patients receiving oral cysteamine therapy. These effects were 

resolved with the addition of diuretic therapy. Reports have also been received 

for patients using ophthalmic cysteamine, however it should be noted these 

patients were concomitantly receiving oral cysteamine therapy. 

o As this product is intended for topical ophthalmic therapy, no drug interactions 

have been reported. 

The clinical efficacy of cysteamine ophthalmic solution was evaluated in three controlled 

clinical trials consisting of approximately 300 patients diagnosed with cystinosis. 

Individuals were measured for their baseline Corneal Cystine Crystal Score (CCCS) prior 

to the initiation of cysteamine ophthalmic therapy. The primary efficacy end point for the 

trials was the response rate of eyes that demonstrated a reduction of at least one unit in 

the photo-rated CCCS at some time point during the study when the baseline CCCS for 

the individual was ≥1, or a lack of an increase of more than one unit in CCCS throughout 

the study for individuals whose pre-treatment baseline CCCS was

OPHTHALMIC AGENTS 


Cysteamine ophthalmic solution is a new, novel entity that provides a reduction cystine crystalline 

accumulation in the cornea of patients diagnosed with Cystinosis. There are currently no other 

commercial ophthalmic products used to treat corneal cystine accumulation and systemic 

cysteamine therapy has generally proven ineffective in preventing corneal accumulation. Use of 

this medication offers patients the possibility of reduced incidence of blindness often experienced 

by individuals with the genetic disorder. Therefore, it is recommended Cysteamine ophthalmic 

solution should be available for use in patients with Cystinosis. 



PREFERRED 

N/A 

NEW: CYSTARAN 

NON-PREFERRED 

CYSTARAN ® (cysteamine hydrocholride) 

Prior Authorization Criteria 

Cystaran will be approved for patients with a diagnosis of cystinosis. 



References 




3. Magellan Medicaid Administration. Cystaran New Drug Update. May, 2013. 

4. Cystaran [package insert]. Gaithersburg, MD; Sigma-Tau Pharmaceuticals; October 2012. 

Page 10 of 14 


Prior Authorization Criteria for Tecfidera ® 

CRITERIA FOR REVIEW 

Will be approved for recipients with a diagnosis of relapsing, remitting Multiple Sclerosis (RRMS) 

who meet ONE of the following criteria: 

Trial and failure of interferon ß or glatiramer 

Contraindication, drug-drug interaction, or intolerance to BOTH interferon ß and 

glatiramer 




Tecfidera ® 

2/day 



Prior Authorization Criteria for Namenda XR ® 

Will be approved for recipients who meet ALL of the following criteria: 

Diagnosis of Alzheimer's disease 

Trial and failure of cholinesterase inhibitor 

Documented intolerance or contraindication to an inactive ingredient that is present in the 

regular-release product, but NOT in the XR product 




Namenda XR ® 

1/day 



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Prior Authorization Criteria for Amitiza ® 


Approval for Amitiza® will be granted upon documentation of: 

Diagnosis of idiopathic chronic constipation AND 

o Trial and failure of at least ONE agent from TWO of the following classes (as 

confirmed by paid claims by TennCare): 

• Osmotic laxatives 

• Bulk-forming laxatives 

• Stimulant laxatives, OR 

Diagnosis of constipation predominate irritable bowel syndrome (IBS) in female, AND 

o Trial and failure of at least ONE agent from TWO of the following classes (as 

confirmed by paid claims by TennCare): 

• Osmotic laxatives 

• Bulk-forming laxatives 

• Stimulant laxatives, OR 

Diagnosis of opioid induced consiptation in chronic non-cancer pain, AND 

o Documentation of paid claims by TennCare for opioids for at least 150 out of 180 

days, AND 

o Trial and failure of both PEG and Lactulose (as confirmed by paid claims by 

TennCare) 



Prior Authorization Criteria for Simbrinza ® 

Simbrinza ® will be approved if the following criteria is met: 

Patient is on simultaneous therapy with brimonidine and Azopt ® for at least 60 days 

Clinically valid reason why patient cannot take 2 agent seperately. 



Prior Authorization Criteria for Vecamyl ® 

Vecamyl will be approved for patients meeting ALL of the following criteria: 

Diagnosis of Essential Hypertension or Malignant Hypertension, AND 

Trial and failure, contraindication or intolerance to ALL of the following: 

o ACE inhibitor or ARB plus a diuretic; AND 

o Beta blocker plus a diuretic, AND 

o Clonidine, AND 

o Hydralazine 




Vecamyl ® 

10/day 



Page 12 of 14 



Prior Authorization Criteria for Liptruzet ® 

Liptruzet ® will be approved for patients meeting ALL of the following criteria: 

Patient already concommitantly receiving atorvatatin + Zetia, AND 

Clinically valid reason why the patient cannot take the two agents seperately 



Prior Authorization Criteria for Signifor ® 

Signifor will be approved for patients meeting ALL of the following criteria: 

Diagnosis of Cushing’s Disease or Cushing’s Syndrome, AND 

Patient has failed surgery (i.e., pituitary, adrenal gland, pancreas tumor removal); OR 

patient is not a candidate for surgery 




Signifor ® 

2 ampules/day 



Prior Authorization Criteria for Simponi ® 

For a diagnosis of Ankylosing Spondylitis: 

Enbrel®, Humira® or Simponi® will be approved for patients who have failed an 

adequate trial of TWO NSAIDs (unless contraindicated). 

Recipients will have to try and fail (or have an intolerance or contraindication to) Enbrel ® 

AND Humira® prior to receiving approval for Simponi® 

For a diagnosis of Rheumatoid Arthritis: 

Enbrel®, Humira®, Kineret®, Cimzia®, Orencia® or Simponi® will be approved for 

patients meeting the following criteria: 

o 

o 

Patient must have failed or been intolerant to at least methotrexate (unless there 

is a documented absolute contraindication such as alcohol abuse, cirrhosis, 

chronic liver disease) AND one other DMARD. 

For recipients who have a contraindication to methotrexate, only one DMARD 

must be tried and failed. 



For a diagnosis of Psoriatic Arthritis: 

 

Enbrel®, Humira®, or Simponi® will be approved for patients who have failed an 

adequate trial of methotrexate (unless contraindicated) 



For a diagnosis of Ulcerative Colitis: 

 

 

Humira ® or Simponi ® will be approved for patients who have tried and failed a 

corticosteroid OR an immunosuppressive agent. 

Recipients will have to try and fail (or have an intolerance or contraindication to) Humira® 

prior to receiving approval for Simponi® 

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