senate health care committee briefing: hepatitis c treatment dan lessler, md chief medical officer...
TRANSCRIPT
Senate Health Care Committee Senate Health Care Committee Briefing:Briefing:
Hepatitis C TreatmentHepatitis C Treatment
Dan Lessler, MDChief Medical OfficerNovember 20, 2014
Hepatitis C OverviewHepatitis C Overview
• Epidemiology & Risk Factors• Clinical Course of Disease• Treatments• Treatment Costs and “ROI”• HCA Policy Approach
2
Hepatitis CHepatitis 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
Hepatitis C: EpidemiologyHepatitis 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
Hepatitis C: Risk FactorsHepatitis 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
Hepatitis C: Clinical CourseHepatitis 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
Hepatitis C: Clinical Hepatitis C: Clinical ManifestationsManifestations
• Hepatitis C may lead to other complications, independent of stage of liver disease:– Kidney disease– Immunologic disorders– Profound fatigue
7
Hepatitis C: TreatmentHepatitis 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
2011 “Breakthrough Treatments”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
2013 “Breakthrough 2013 “Breakthrough Treatments”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/pill10
Hepatitis C: Breakthrough Hepatitis C: Breakthrough TreatmentsTreatments
• 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
Hepatitis C: Breakthrough Hepatitis C: Breakthrough TreatmentsTreatments
• 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
Hepatitis C Treatment: Clinical Hepatitis C Treatment: Clinical EconomicsEconomics
• “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
Hepatitis C: Prevalence Hepatitis C: Prevalence EstimatesEstimates
• 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
http://www.hcvguidelines.org/full-report-view
16
Whom to TreatWhom 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
Policy Development: Key ConceptsPolicy 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
AASLD/IDSA: Highest PriorityAASLD/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
HCA Hepatitis C Policy HCA Hepatitis C Policy DevelopmentDevelopment
• 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
