1. Senate Health Care Committee Briefing: Hepatitis C Treatment Dan Lessler, MD Chief Medical Officer November 20, 2014

2. Hepatitis C Overview Epidemiology & Risk Factors Clinical Course of Disease Treatments Treatment Costs and “ROI” HCA Policy Approach 2

3. Hepatitis C Caused by an RNA virus Prior to 1989, known as “Non-A, Non-B hepatitis” Multiple “types” – Type 1 most common – Types 2, 3 and 4 less common 3

4. Hepatitis C: Epidemiology Most common cause of chronic hepatitis C virus (HCV) Leading cause of cirrhosis and liver cancer in the U.S. Leading reason for liver transplantation in the U.S. Approximately 1% of U.S. general population has chronic hepatitis C infection Prevalence is greatest in those born between 1945 and 1965 – USPSTF recommends screening all people born between 1945 and 1965 4

5. Hepatitis C: Risk Factors Blood to blood contact (e.g., IV drug use) Blood transfusion prior to 1992 Receive hemodialysis Received body piercing or tattoos with non-sterile instruments Known exposure to hepatitis C virus Infected with HIV Vertical transmission from infected mother to child in <10% of pregnancies Not spread by breastfeeding 5

6. Hepatitis C: Clinical Course Of every 100 people infected with hepatitis C: Between 15 and 25 will clear the infection 75-85 will develop chronic infection; of these: – 60-70 will go on to develop chronic liver disease (some degree of scarring) – 5-20 will go on to develop cirrhosis over a period of 2-30 years (more severe form of scarring) – 1-5 will die from cirrhosis and liver cancer 6

7. Hepatitis C: Clinical Manifestations Hepatitis C may lead to other complications, independent of stage of liver disease: – Kidney disease – Immunologic disorders – Profound fatigue 7

8. Hepatitis C: Treatment Goal: Sustained Viral Response (SVR) – No measurable virus – Proxy for “cure” Standard treatment, prior to 2011: peg- interferon and ribavirin (aka, “PR”) combination – High rate of toxicity – <50% effective in most common type of hepatitis C 8

9. 9 2011 “Breakthrough Treatments” First generation direct-acting antiviral (DAA) protease inhibitors approved for Type 1 Hepatitis C – Victrelis ® (boceprevir) 24-32 wks + PR 28-48 wks – Incivek ® (telaprevir) 12 wks + PR 24-48 wks More effective than PR in achieving SVR (70%) Many pills taken about every 8 hours Marked increase in anemia (≤50%) Significant drug-drug interactions 9

10. 2013 “Breakthrough Treatments” Sofosbuvir (Sovaldi ® ) and Simeprivir (Olysio™) Sofosbuvir (“Sovaldi”) – More effective than prior available treatments (up to 90% SVR) – Enables treatment without the use of interferon in genotypes 2 and 3 – For genotype 1 (most common type of HCV) and 4, still need interferon and ribavirin, but only for 12 weeks (vs 24-48 weeks) – Cost ~$1000/pill 10

11. Hepatitis C: Breakthrough Treatments October 2014, FDA approves combination pill with sofosbuvir and ledipasvir (Harvoni ® ) – Highly effective and safe in the treatment of Hepatitis C genotype 1 (most common type) – One pill daily for 12 weeks (some may be treated in 8 weeks) – Interferon and ribivarin no longer necessary to treat type 1, thereby avoiding their toxicities 11

12. Hepatitis C: Breakthrough Treatments New pricing paradigm: – “Drug for a common disease, priced like an orphan drug.” (Steven Miller, MD; CMO Express Scripts) – Harvoni ~ $94,500 for typical course of treatment Additional “breakthrough” hepatitis C drugs from other manufacturers will soon be approved by FDA 12

13. Hepatitis C Treatment: Clinical Economics “Even at a 20 year horizon, if all patients infected with hep C are treated with the new regimens, the cost offset will only cover approximately ¾ of initial drug costs…” “…Costs saved by reducing liver-related complications in [a subgroup of patients with advanced fibrosis] would produce a net savings to the statewide [California] health care systems of approximately $1 billion after 20 years.” 13 Institute for Clinical and Economic Review, final report to the California Technology Assessment Forum, April 15, 2014

14. Hepatitis C: Prevalence Estimates Medicaid populations – Estimated prevalence: 21,000 PEB population – Estimated prevalence: 3,883 CDC estimates that ~50% of the U.S. population has been screened 14

15. 15 http://www.hcvguidelines.org/full-report-view

16. 16 Whom to Treat Chronic HCV infection The need to prioritize – Limitations of workforce – Societal resources --- financial – Treat as many as resources allow How to prioritize – Those who will derive the most benefit --- highest risk of complications without treatment – Those that have the greatest impact on further transmission

17. 17 Policy Development: Key Concepts Not all infected patients develop chronic liver disease Progression to more severe disease (cirrhosis) takes 20-30 years Patients with more severe disease are at greatest risk of developing complications of cirrhosis and hepatocellular (liver) cancer

18. 18 AASLD/IDSA: Highest Priority AASLD/IDSA: Highest Priority Patients with advanced fibrosis and compensated cirrhosis (Metavir F3/F4) Pre- & post-liver transplant recipients Severe extrahepatic (non-liver) complications of HCV -Type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations -HCV kidney disease: proteinuria, nephrotic syndrome or MPGN

19. HCA Hepatitis C Policy Development September 15, 2014 – Convened all payers/vendors (PEB and Medicaid) with whom HCA contracts – Discussed clinical approach to identifying and prioritizing the treatment of people with chronic hepatitis C infection – Goal: uniform clinical policy across all payers Policy drafted, sent for review and comment Current status: HCA finalizing clinical policy 19

20. Questions? Daniel Lessler, MD, MHA Chief Medical Officer daniel.lessler@hca.wa.gov 360-725-1612 20