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Specialty Pharmacy Benefit Management Discussion – Hepatitis C. April 2, 2013. Panel Participants. Defining Hepatitis C (HCV). Chronic HCV Leads to Many Liver-related Complications. HCV Infection is #1 cause of liver transplants in the U.S. Hepatocellular carcinoma. Chronic HCV.

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Specialty Pharmacy Benefit Management Discussion – Hepatitis C

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    1. Specialty Pharmacy Benefit Management Discussion – Hepatitis C April 2, 2013

    2. Panel Participants

    3. Defining Hepatitis C (HCV)

    4. Chronic HCV Leads to Many Liver-related Complications HCV Infection is #1 cause of liver transplants in the U.S. Hepatocellular carcinoma Chronic HCV Liver Transplant CIRRHOSIS Decompensated cirrhosis Death While sustained virologic response (SVR) rates in patients with cirrhosis are reduced, those that achieve SVR have lower rates of hepatitis C virus (HCV)-associated complications compared with non-responders.

    5. Treatment Success = SVR … However, Other Outcomes are Possible Start of treatment End of treatment Breakthrough Null Relapser Partial Undetectable HCV RNA in plasma HCV RNA (log10 IU/mL) SVR Viral Eradication 24 4 8 12 16 20 32 40 48 56 24 weeks post -treatment 0 Weeks Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management and treatment of Hepatitis C: An update. Hepatology. 2009;49(4):1335-1374.

    6. Panel Participants

    7. Matthew Mitchell PharmD, MBA Manager, Pharmacy Services SelectHealth

    8. SelectHealth/Intermountian Healthcare • Non-profit Integrated Health Care System • Facilities • 25 hospitals and 150 medical facilities and physician offices located throughout Utah and Idaho • Physicians • 900 employed physicians • 2,500 affiliated physicians • Health Plan • 635,000 enrollees • Home care and Specialty Pharmacy

    9. Specialty Steering Committee • Strategic direction and planning • Fee schedule • Maintain appropriate group of providers • Discussion of incentive programs or special fee arrangements • Evaluate product procurement/administration • Includes need for specialty pharmacy • Determine preferred products • Establish coverage criteria • Pre Authorization, Step Therapy, Duration of Therapy, Quantity Limits, Specialist Only Prescribing, Case Management Priorities, etc.

    10. Specialty Activities • Injectable/Specialty Trends • Members, Units, Allowed Cost, %increase/qtr, %increase/year, PMPM • Evaluate warehousing of HCV patients • Pipeline review • Therapeutic class reviews • Coordination with clinical program teams/key providers • Create and maintains Specialty Steering Committees i.e. Rheumatology, Neurology, Oncology • Timely Topics

    11. HCV Specific Management • Preferred treatment agents • Different per line of business • Prior Authorization • Help ensure appropriate genotype, drug selection, and duration • Care management coordination • Auto generated reports and personal referrals • Specialty pharmacy coordination • Includes compliance and rates of viral response

    12. Cheryl Allen, BSPharm, MBA Vice President, Business Development & Industry Relations Diplomat Specialty Pharmacy

    13. Diplomat’s Mission Position: The nation's largest privately-held specialty pharmacy. Mission: Being a customer focused and innovative partner, providing medication management and clinical services in a caring, cost-effective, supportive environment; keeping patients healthier longer… one patient at a time.

    14. Evolving Specialty Pharmacy Partnerships Patients Payors/Exchanges Prescribers Retailers* Diplomat Specialty Pharmacy Health Systems/ Hospitals* Pharmaceutical Manufacturers

    15. Core Medication Management

    16. Clinical Intervention Schedule

    17. Patient Education Packets HCV Care Kit • Hydrocortisone cream, carrying case, chapstick, magnet • Rash tip card with instructions for use, non-drug management techniques, when to contact HCP • New patients receive HCV Basics, HCV Side Effect Management, and HCV Specialty Care Overview • Additional side effect management brochures available: Anemia, Flu-like symptoms, Fatigue, Headache, Nausea and Vomiting, Rash, Etc. Enhanced Clinical Services

    18. David Coury, PharmDDirector of Business DevelopmentAcro Pharmaceutical Services

    19. Who Is Acro? Acro is a Pharmacy Care Management company with a specific focus on the distribution and clinical aspects of high cost pharmaceutical products. 19

    20. Who Is Acro? Acro Pharmaceutical Services is owned by Lincare Holdings, a subsidiary of The Linde Group Revenue 2012 ~ $2 billion Over 11,000 employees 1100+ sales people Over 500 Nurses on Staff 30 closed door pharmacies across United States 26 infusion + 4 mail order + Acro Specialty Pharmacy (HUB) Over 85 RNs and 102 Pharmacists 20

    21. Acro/Lincare Pharmacy Services * Mail Order Pharmacy Lincare Pharmacy Locations Staffing Includes: 102+ Pharmacists and 85+ Nurses 21

    22. Acro HCV Pharmacy Experience • Patients: Majority are Managed Medicaid • Referrals Prescriptions Sent to Acro by Payer Prior authorization Depts. • Reauthorization Scripts Sent to Acro or upon Acro request to plan • Provide Necessary Clinical / Financial Support • 24/7 clinical pharmacist availability • Refer patients to clinical and Financial support programs • Provide Automatic Live outreach calls to members for refill scripts • Any patient not contacted for refills, physician office is notified due to compliance concerns

    23. Acro HCV Pharmacy Experience Key Challenges: • Transient Patients – Lose patients due to changing health plan also gain patients from health plans already into therapy - Complex prior authorization process for payers and necessary coordination with specialty pharmacy • Treatment regimens vary not set until initial HCV responses are assessed, up to 3 reauthorization points • Not always apparent how long the patient should be on therapy based on authorization notices because patient history is not always known

    24. Erik Halstrom Vice President, Specialty Pharmacy Solutions Managed Health Care Associates, Inc:MHA is a leading health care service company that helps alternate site health care providers compete in their respective markets Confidential - Do Not Distribute

    25. MHA – A Health Care Service Company Confidential - Do Not Distribute

    26. Group Purchasing Business Units >530 Home Infusion & Specialty pharmacies >1,200 sites of service >830 Exclusive LTC Pharmacy providers >1,500 sites of service >4,700 Nursing Home providers >11,000 locations >500 Rehab, DME, Sleep and Respiratory providers >1,600 locations Confidential - Do Not Distribute

    27. MHA Specialty Sales for Top 7 Therapeutic Areas $6.8B in Total Sales All active members (excluding Omnicare & Pharmerica); Annualized Sales Q4 2011 – Q3 2012 Contracted & Non contracted Sales All COTs: Retail, Specialty Pharmacy/HI, HMO Staff Model, Clinics, LTC and all others. Source: Midas SQL Trak

    28. Clinical Support Pathway Outreaches are based on individual patient needs Review key patient demographics Evaluate knowledge of disease state and therapy Assess medication history and identify barriers to treatment success Review goals of therapy and treatment expectations Comprehensive clinical patient-focused program designed to help patients achieve optimal outcomes of their prescribed treatment regimen Facilitates guided communication with patient, payer, and physician’s office Program is based upon identified outreaches to the patient at key intervals to provide timely: • Education • Treatment support • Individualized patient counseling Provides a clinical support pathway to enhance patient care and facilitates the collection of clinical and dispensing metrics for specialty reporting. Confidential - Do Not Distribute

    29. Confidential - Do Not Distribute

    30. Coy Stout VP, Managed Markets Gilead Sciences

    31. Disclaimer • Gilead has a development pipeline for Hepatitis C therapies but does not have an approved product for Hepatitis C treatment at this time • This presentation and speaker comments are based on general discussion around current and potential future Hepatitis C therapies but do not specifically refer to any particular Gilead pipeline product or products

    32. Gilead Sciences • Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, we seek to improve the care of patients suffering from life-threatening diseases. • Gilead’s primary areas of focus include HIV/AIDS, liver disease, serious cardiovascular and respiratory conditions, oncology and inflammation. • Founded in 1987 in Foster City, California, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio and growing pipeline of investigational drugs. • In 2012, Gilead attained $9.7 billion in annual global revenues and employs over 5,000 people

    33. Evolving HCV Treatment Dynamics • Past • 48 weeks of therapy (injectable + oral) • Low response rates in GT1 • Present • 24-48 weeks of therapy (injectable + oral) • Response guided therapy considerations • Better response rates in GT1, not indicated for GT 2/3 • Side effect management considerations • Potential Future Treatments (many candidates in pipeline from multiple companies) • Shortened duration of therapy • Reduce or eliminate injectable component of therapy • Pan-genotypic regimens possible • No response guided therapy • Well-tolerated (less focus on side effect management)

    34. Manufacturer Considerations • With new therapies, does the current distribution paradigm change? • Need for payer network compatibility • Institutional access (e.g., corrections, VA) • Capacity • What patient support programs are needed in the future for short-duration, all oral therapy? • Specialty pharmacies play an important role in patient education, coordination of benefits, linkage to patient support programs…where else can we work together to ensure appropriate use and goals of therapy are reached?

    35. Hepatitis c Overview

    36. HCV Therapy Challenges • Low Adherence Mitra D, et al. Treatment Patterns and Adherence among patients with chronic hepatitis C virus in a US managed care population. Value in Health. 2010; 13(4): 479-486

    37. Adherence is Critical According to HCV Guidelines NIH Consensus Statement on the Management of Hepatitis C (2002)1: • “Patient adherence is critical to the success of HCV treatment.” Physicians are encouraged to help patients maximize adherence by managing their side effects, depression and substance abuse. American Association for the Study of Liver Diseases (AASLD )Practice Guidelines: Diagnosis, Management, and Treatment of Hepatitis C: An Update (2009)2: • Patients “should also be queried about adherence to treatment.” Institute of Medicine (IOM) Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C (2009)3: • Components of Comprehensive Viral Hepatitis Services: “Adherence Support” 1Management of Hepatitis C: 2002. National Institutes of Health Consensus Conference Statement. NIH Consensus Development Program. June 10-12, 2002. http://consensus.nih.gov/2002/2002HepatitisC2002116html.htm. Accessed 6/2011. 2Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management and treatment of Hepatitis C: An update. Hepatology. 2009;49(4):1335-1374 3 Colvin HM, Mitchell AE. Hepatitis a and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C. National Academy of Sciences. 2010. http://www.nap.edu/catalog.php?record_id=12793. Accessed 6/2011.

    38. 80/80/80 Rule is Goal for HCV Treatment 80% of interferon dose 80% of ribavirin dose 80% of prescribed treatment regimen McHutchison JG, et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology. 2002;123:1068.

    39. Hepatitis C Non-Adherence 2011 Express Scripts Specialty Drug Trend Report

    40. Adverse Events Impact Adherence

    41. Pill Burden and Complex Treatment Regimens Impact Adherence DAILY WEEKLY RIBAVIRIN: 3 tabs 2x a day PLUS -PLUS- Peg-IFN injection OR VICTRELIS: 4 tabs 3x a day INCIVIK: 2 tabs 3x a day

    42. Predictors of Poor Response to Therapy McHutchison JG, et al. Adherence to combination therapy enhances sustained response in genotype-1-infected patients with chronic hepatitis C. Gastroenterology. 2002;123:1068.

    43. HCV Ranks #7 In top 10 Specialty Therapy Classes 2011 Express Scripts Specialty Drug Trend Report

    44. HCV Pipeline • Novel therapies in Phase II and III – targeted launch in 2014 and beyond: • New MOAs • New combinations • Dual/triple therapy • Novel interferons • Therapy without interferon 2011 Express Scripts Specialty Drug Trend Report

    45. New CDC Recommendations: Hepatitis C Testing for Anyone Born During 1945-1965 • There are high rates of Hepatitis C in people born during 1945-1965.  • People born during 1945 through 1965 are 5 times more likely than other adults to be infected. • 75% of adults with Hepatitis C were born in these years • Testing can help prevent deaths from Hepatitis C.  • It is estimated that one-time testing of everyone born during 1945 through 1965 will prevent more than 120,000 deaths. • There is a lack of awareness. • One-time testing of everyone born during 1945 through 1965 would find an estimated 800,000 undiagnosed Hepatitis C cases. • There have been recent advances in treatment. • For many people with Hepatitis C, medical treatment can result in the virus no longer being detected in the blood.

    46. Audience questions