overview of a specialty pharmacy - Express Scripts

overview ofa specialty pharmacyCuraScript Specialty Pharmacy Management Guide & Trend Report

Overview of a Specialty PharmacySpecialty pharmacies use several strategies to address the challengingcharacteristics of specialty drugs. These strategies include:• Availability of specialty medications and supplies for administration• Experienced and knowledgeable clinical-support teams• Patient-care coordination and compliance monitoring• Coordination of home-care services• Clinical pharmacy management of disease-specific programs• Pharmacy and medical benefit billing and reimbursement• Combined pharmacy and medical benefit specialty-drugutilization management• Formulary management support servicesMost specialty drugs are used to treat chronic diseases that affect lessthan 3% of the general population. Thus, the volume of specialty-druguse is relatively low when compared with the use of traditional drugs.Additionally, many of the specialty drugs currently available are not availablethrough open distribution channels. Due to lowered treatment prevalenceor limited supply of the drugs, pharmaceutical manufacturers may controlaccess to their specialty products by using specified distributors. Thesedistribution factors, combined with the typically high acquisition andinventory carrying costs associated with specialty drugs, make specialtydrugdistribution impractical for traditional distribution channelssuch as retail pharmacies.overview of a specialty pharmacySpecialty pharmacies focus on the supply and distribution of specialtydrugs; therefore, they have immediate inventory of specialty drugs andthe supplies needed for proper administration. Specialty-drug distributorswork with manufacturers and wholesale distribution channels to ensurecontinuous supplies and to leverage volume, resulting in discounts thatcan be passed to clients.19

overview of a specialty pharmacyPATIENT-CARE COORDINATIONPatient-care coordination is the process that oversees multiple aspects of therapyfor patients receiving specialty drugs. Because specialty-drug treatment maychange frequently, patient-care management includes monitoring for:• Adequate home or office inventory levels of the drugs• Adherence to prescribed drug regimens• Continuity of care• Coordination of home-care services• Patient assessment screening surveys• Ongoing prior authorization requirements• Eligibility or benefits changesPatient-care coordinators work in conjunction with licensed cliniciansto provide comprehensive clinical-management services. By providingpatient-assessment screening surveys at each refill, patient-care coordinatorsassist the clinical team in identifying high-risk patients and adverse clinicalevents at routine intervals. Exhibit 11 provides an example of a CuraScriptpatient-care management process flow.Exhibit 11CuraScript Patient-Care Management Process Flow20 CuraScript specialty pharmacy management guide & trend report 2004

Specialty drugs have unique handling and administration needs thatrequire knowledgeable management. Therefore, specialty pharmaciesrecruit healthcare professionals who have experience with the treatmentof patients using specialty drugs. Similar to physicians who require specificeducational backgrounds to specialize in the treatment of diseases suchas hepatitis and multiple sclerosis (MS), healthcare professionals whomanage specialty drugs also require specialized, ongoing training tomaintain high levels of expertise. Standard training for pharmacistsdoes not specifically address the handling requirements of specialtydrugs. Additionally, the majority of pharmacists do not encounterthese drugs in general practice. Specialty pharmacists, however, undergoextensive education in all aspects of specialty-drug management.CLINICAL MANAGEMENTIn addition to pharmacist specialization and training, specialty-drugmanagement frequently extends beyond the pharmacy and the physician’soffice, since patients will often require home-healthcare services to supportin-home injection training or ongoing infusion services. Therefore,specialty pharmacies need to be able to provide coordination of nursingservices in the home setting. Many times the need for nursing care maybe a one-time, education and training home visit — not a long-termneed. Separating drug delivery from nursing care often decreases costsby limiting higher-than-necessary levels of care.overview of a specialty pharmacyClinical pharmacy oversight can often be provided by telephone, reducingthe need for acute in-home services. Thus, specialty pharmacies usea multidisciplinary team of experienced registered nurses and socialworkers, in addition to trained pharmacists, to support the complexmanagement requirements of chronically ill patients receiving specialtymedications. This team of licensed clinicians provides clinical management,including the following interventions:• Medication self-administration oversight• Clinical assessment and patient monitoring• Disease state and medication education• Side-effect management• Physician consultation• Drug utilization evaluation and poly-pharmacy review21

overview of a specialty pharmacy• Therapeutic interchange and formulary management• Care coordination with other healthcare providers• Psychosocial support• Community resourcingThese services bring the added value of disease-management conceptsto pharmacy, with critical pathway management and targeted, proactiveclinical interventions at specific intervals throughout treatment to optimizeclinical outcomes. Ongoing, objective measurement of clinical-outcomesindicators specific to the disease and its treatment is paramount to quantifyingthe success of care-management strategies. For example, in the treatmentof rheumatoid arthritis (RA) with specialty medications such as Enbrel ®or Humira ® , the key measurements of response to the treatment areimproved joint mobility and functional capacity, which can bothbe measured objectively at established intervals. By evaluating clinicalmeasurements, specialty pharmacies can document and providetreatment outcomes to clients.A high rate of adherence with specialty-drug regimens is often criticalto both short- and long-term outcomes. For example, therapy adherenceof greater than 80% is linked directly to positive treatment outcomesfor patients with hepatitis C. 9 Specialty-pharmacy programs, suchas patient-care management and clinical oversight by experiencedhealthcare professionals, increase adherence rates among specialtypharmacypatients when compared with patients receiving drugsfrom other distribution channels.Exhibit 12 presents the results of one analysis that evaluated adherencerates between patients using CuraScript Specialty Pharmacy versusretail pharmacies to obtain drugs to treat hepatitis C.9McHutchinson JG, et al. Adherence to combination therapy enhances sustained response in genotype 1 infected patients withchronic hepatitis C. Gastroenterology. 2002;123:1061-1069.22 CuraScript specialty pharmacy management guide & trend report 2004

Exhibit 12Adherence to Hepatitis C TherapySpecialty Pharmacy vs Retail Pharmacy Distribution Models 10100806040200overview of a specialty pharmacy10Burton, D., Shenouda, S., Smith, C., Spears, J. Adherence to Hepatitis C Treatment Based on Refill Rates, PosterPresentation, Academy of Managed Care Pharmacy 17th Annual Meeting, April 2005, Denver.23

overview of a specialty pharmacyBILLING, REIMBURSEMENT AND DATA MANAGEMENTCoverage for specialty drugs may be provided under the medical benefit,the prescription-drug benefit or both. Due to these complex coverageissues, specialty pharmacies must be prepared to manage multiple typesof billing and reimbursement, ranging from electronic adjudicationusing the National Council for Prescription Drug Programs (NCPDP)format to more traditional paper claims. The higher cost of specialtydrugs leads to other billing-related issues that include coordination ofbenefits and prior authorization requirements. To be successful, specialtypharmacies must also support these additional reimbursement needs.Combined prescription- and medical-benefit billing requirementsin a specialty-pharmacy setting also create unique opportunities forcomprehensive specialty-utilization management. Working with clientsponsors, specialty pharmacies have designed programs that superviseappropriate utilization of specialty drugs and ensure medical necessityof ongoing treatment, regardless of benefit coverage.For example, to manage the treatment of RA, clients need to considerall of the specialty RA drugs. Although most self-injected specialty drugsfor RA (Humira ® , Enbrel ® and Kineret ® ) usually are currently coveredas a prescription-drug benefit, another specialty drug used to treat RA,Remicade ® , an infused agent, is more likely to be covered under medicalbenefits. Requiring prior authorization on the prescription-drug benefitside could increase the use of these drugs on the medical benefit sideif medical benefits are not also managed. By distributing all four productsthrough a specialty pharmacy, however, the client can evaluate all thespecialty-drug treatments for appropriateness prospectively — regardlessof benefit coverage — not only when they are started, but also periodicallyduring therapy.In evaluating combined pharmacy and medical benefit specialty-drugutilization management, the following results were reported at the spring2004 Academy of Managed Care Pharmacy meeting (Exhibit 13).24 CuraScript specialty pharmacy management guide & trend report 2004

overview of a specialty pharmacyContinued27

overview of a specialty pharmacySpecialty pharmacies are positioned not only to provide formularyadministrative and consultative services, but also to align the payer’scost-containment objectives with optimal therapy. Formulary managementfor specialty drugs, similar to traditional oral medications, requiresmanagement oversight to maximize penetration and performancefrom the formulary offering.In analyzing all the services required to manage specialty drugs andthe required services provided by specialty pharmacies to meet this need,it is evident that not all distribution channels are set up operationallyto handle the unique challenges of specialty drugs’ inherent servicerequirements. Exhibit 15 compares the various distribution channelsbased on service requirements of specialty drugs.28 CuraScript specialty pharmacy management guide & trend report 2004

overview of a specialty pharmacyNotes30 CuraScript specialty pharmacy management guide & trend report 2004