New Therapies for HCV, What About the Cost? Benjamin P. Linas, MD,MPH June 16, 2014

Transcription

1 + New Therapies for HCV, What About the Cost? Benjamin P. Linas, MD,MPH June 16, 2014

2 + The Good 95% plus SVR! 12 weeks therapy (likely less)! Very little toxicity! Treatment in primary care! Maybe we can eradicate HCV?!

3 + The Bad $1,000 per dose sofosbuvir? cost for co-formulated regimens Approximately 3 million HCV-infected in the U.S.

4 + The Bad $250 - $300 billion for drugs alone to treat all. Many patients are either: Uninsured Medicaid D.O.C.

5 + The Ugly

6 + The Ugly

7 + The Ugly

8 + The Ugly

9 + The Ugly

10 + Projections of HCV Burden in the U.S. Razavi et al. Hepatology 2013

11 + What are the costs? The cost of drugs alone is not the cost that really matters. The TOTAL cost of therapy matters more including toxicity costs. Interferon has a lot of toxicity.

12 + Cost of drugs PEG/RBV/TPV x 24 weeks SOF/RBV x 12 weeks $622/week $7,000/week $637/week $637/week $3,788/week $75,632/24 week course $91,644/12 week course

13 + Resource Utilization During HCV Therapy Average utilization (per person) PEG/RBV PEG/RBV/TPV ER visits (pre-tx) ER visits days Outpatient visits (pre-tx) Outpatient visits (days 0-89) Lab tests (pre-tx) Lab tests (days 0-89) Nyberg et al. Digestive Disease Week 2014 abstract 778. May , Chicago, IL, USA

14 + Rate of Sustained Virologic Response (SVR) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% PEG/RBV/SMV HCV genotype 1 SOF/LDV

15 + Cost per SVR including non-drug costs. Regimen Cost/SVR Peg/RBV $127,808 PEG/RBV/BOC $141,140 PEG/RBV/TPV $174,775 SOF/RBV?? SOF/LDV?? Nyberg et al. Digestive Disease Week 2014 abstract 778. May , Chicago, IL, USA

16 + Projecting cost/svr with SOF Used Hepatitis C Cost-Effectiveness Model (HEP-CE). Monte Carlo simulation of HCV and HCV therapy. Simulates treatment of HCV and life-time outcomes. Included cost of drugs, cost of toxicity, cost of MD visits.

17 + Monte Carlo Simulation Well Dead Sick

18 + Assumptions ( Dirty look) SOF/LDV cost $100,000 - $120,000 per treatment course. SOF/LDV 97% SVR. SOF/LDV has similar toxicity to SOF/RBV.

19 + Cost per SVR Regimen Cost/SVR Peg/RBV $127,808 PEG/RBV/BOC $141,140 PEG/RBV/TPV $174,775 SOF/LDV (co-form = $120,000/course) **$161,600** SOF/LDV (co-form = $100,000/course) **$134,400** ** = simulated data for the purpose of discussion only

20 + Normalized Costs On a cost/svr basis, $100,000/treatment course may not be that different than PEG/RBV/TPV. Wouldn t we rather spend resources on curing patients than on treating toxicity? Higher efficacy and lower toxicity can support higher drug costs.

21 + Understanding true cost Thinking about the cost of HCV therapy requires thinking about more than just the price of pills.

22 + What do we care about? SVR is important because it decreases morbidity and mortality.

23 + Patients With SVR Have Similar Mortality to General Population Van der Meer et al. AASLD 2013 abstract 1425.

24 + What do we care about? Not all SVR = life saved There is no liver-related mortality from HCV until patients develop cirrhosis. The median time from HCV infection to cirrhosis is about 20 years. There are a lot of competing risks of death in HCV-infected patients.

25 + What do we care about What we really care about is extending life expectancy. We would like to know the cost /lifeyear gained or cost/quality-adjusted life-year gained.

26 + Cost-Effectiveness Cost-effectiveness research seeks to answer these types of questions: 1. How can I maximize the benefits of the resources I have available to me? 2. If I have one extra $, how should I spend it?

27 + Cost-Effectiveness Cost-effective cost-saving Cost-effective cost-saving Cost-effective cost-saving

28 + Cost-Effectiveness Analysis Two outcome measures: Cost ($) Benefit (life years, quality-adjusted life years) Incremental Cost-Effectiveness Ratio (ICER) Additional resources used Additional health benefits

29 + Results from Model Strategy Total Cost ($) Incremental Cost ($) LE (Yrs) Incrementa l LE (Yrs) ICER Treat none 29, Treat all 45,000 15, ,000 Test 52,463 7, ,038

30 + Important Points All cost-effectiveness ratios are incremental. Always ask yourself - compared to what?

31 + How Do We Interpret ICERs? ICER test vs. treat all = $35,038/QALY What does that mean?

32 + Willingness to Pay Societal willingness to pay threshold. The price that we are willing to pay to save one QALY. Can be different in different places. Feels uncomfortable, but we do this all of the time without really thinking about it.

33 + What Are We Willing to Pay? $/YLS or $/QALY Propranolol, mild hypertension $ 14,000 Thrombolytic therapy for an acute MI $ 39,000 Dialysis, end-stage renal disease $ 51,000 Dialysis, seriously ill adults $147,000

34 + What Are We Willing to Pay? U.S. $50,000-$100,000/QALY WHO - 1x per capita GDP = very cost-effective 3x per capita GDP = cost-effective

35 + Questions?

36 + Applying Cost-Effectiveness to HCV Drugs Trend toward high value Low drug cost Poor treatment alternatives Lower toxicity High risk of HCV-related death Trend toward low value High drug cost Effective treatment alternatives Higher toxicity Low risk of HCV-related death

37 + Considerations in Practice Genotype Treatment experience Fibrosis stage

38 + ICERs of Sofosbuvir (preliminary) Patient type Comparison ICER Genotype 2 Naïve Non-cirrhotic Genotype 2 Experienced Non-cirrhotic Genotype 2 Naïve Cirrhotic Genotype 1 Naïve Non-cirrhotic SOF/RBV v. PEG/RBV SOF/RBV v. no tx SOF/RBV v. PEG/RBV SOF/LDV v. PEG/RBV/SMV ($125,000 drug cost) >$200,000/QALY $50,000-$100,000/QALY <$50,000/QALY $100,000- $200,000/QALY*** Preliminary for discussion

39 + Summary New therapies have amazing promise. High cost is a major stress on current system. For some patients, new meds are likely cost-effective even at very high cost.

40 + Summary For patients with early disease who have other treatment options, new meds may not provide good value for money. Options? Status quo? Prioritize patients with advanced disease and no options? Negotiate cost?

41 + Thank You NIDA R01DA MGH Arthur Y. Kim, MD Kenneth A. Freedberg, MD, MSc Harvard School of Public Health Milton C. Weinstein, PhD Joshua A. Salomon, PhD BU School of Public Health C. Robert Horsburgh, MD Boston Medical Center Sabrina A. Assoumou, MD, MPH Laura White, PhD Mathew Harrigan, BS Wei Huang, MS Weill Cornell Medical School Bruce R. Schackman Jared A. Leff University of Chicago Mai T. Pho, MD, MPH