A Case for Market-Based Costs in Determining Cost-Effectiveness: The Hepatitis C Example

Transcription

1 A Case for Market-Based Costs in Determining Cost-Effectiveness: The Hepatitis C Example Avalere Health An Inovalon Company November 2015

2 Executive Summary HCV Cost- Effectiveness Studies Studies assessing newer HCV agents generally demonstrated cost-effectiveness even though they use the medications list prices Marketplace Realities The market has produced significant publicly reported discounts that have not been factored into most analyses Best Practice Costing Methodology Accounting for these marketplace realities, a best practice recommended by ISPOR Task Force guidelines, would more accurately measure cost-effectiveness HCV: Hepatitis C Virus ISPOR: International Society for Pharmacoeconomics and Outcomes Research 2

3 Background FDA has approved several direct-acting antiviral medications since 2013 The medications are associated with a high clinical cure rate, but carry a relatively high cost Cost-effectiveness research seeks to assess the value of new medications in light of the higher costs at launch of innovative drugs Cost-effectiveness models in HCV may be particularly sensitive to how costs of the newer medications are defined The costing exercise can be complex and can involve a variety of assumptions about the market dynamics of the newly marketed drug FDA: U.S. Food and Drug Administration 3

4 Research Objectives 1 Summarize the results of recently published U.S. HCV costeffectiveness studies examining the new direct-acting antivirals from the payer perspective 2 Determine the extent to which the models integrated established methodological guidelines 1 for utilizing marketbased pricing rather than published list prices 1 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force for Good Research Practices published guidelines on use of drug costs in cost-effectiveness analyses suggest that cost-effectiveness analyses performed from a payer perspective should use drug prices actually paid by the relevant payer net of all rebates, copays, other adjustments. 4

5 Results Indicate a General Trend of Cost- Effectiveness for the Newer HCV Treatments INDICATES GOOD VALUE UNDER GENERALLY-ACCEPTED THRESHOLDS Identified Articles, Abstracts, and HTAs by Genotype Focus (N=7) Genotype 1 Gentoype 1-4 Genotype 2-3 Sofobuvir-based regimes were most commonly assessed while paritaprevir/ritonavir/ombitasvir, dasabuvir, and daclatasvir were also examined Five studies measured costs and benefits over a lifetime horizon, while two studies utilized a oneyear time horizon Under the commonly accepted cost per QALY thresholds ($50,000- $100,000/QALY), the newer directacting antivirals most often deemed cost-effective HTA: Health Technology Assessment QALY: Quality-adjusted life year 5

6 Many Models Did Not Capture Market-Based HCV Drug Pricing and Publicly Reported Discounts STUDIES MAY NOT REFLECT ACTUAL PRICES PAID BY PAYERS Inconsistency in the degree to which models from payer perspective reflected anticipated or actual net HCV drug pricing realities in the marketplace Results from these analyses may actually underestimate the degree of cost-effectiveness depending upon the level of net pricing that may be realized in the marketplace ONLY ONE STUDY 1 APPROXIMATES PUBLICLY REPORTED DISCOUNTS OF 0% TO 44% Conforms most closely with ISPOR Task Force guidelines by introducing net pricing as a distinct cost input Even with 0% discount, HCV agents still possessed a cost per QALY well below $100,000, indicating high value 1 Chhatwal J, Kanwal F, Roberts MS, et al. Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United States. Annals of Internal Medicine. 2015;162:

7 Important to Use Sound Costing Approach to Deliver Assessments that Reflect Marketplace Realities Consensus guidance dictates that, where possible, all reported or reasonably anticipated rebates, discounts, etc. should be considered as an input for treatment cost comparison Many payers realize discounts not reflected in a benchmark price (e.g., WAC) Using benchmark prices could potentially lead to inflated cost-effectiveness ratios that lead to improper assessments of treatments value As newer agents enter the market leading to increased competition and rebates, we would encourage authors to update cost estimates in previously published models to better reflect current marketplace realities (i.e., available discounts) Based on our review of the published models from the payer perspective, those that found the new HCV agents to be cost-effective absent the use of market-based discounts are underestimating value WAC: Wholesale Acquisition Price 7

8 Appendix

9 Methods Avalere conducted a literature search to identify the body of relevant HCV direct-acting antivirals cost-effectiveness research o PubMed search based on combinations of newly marketed HCV drug names (e.g., sofosbuvir) and study design (e.g., cost utility) search terms o Limited to studies conducted in adult humans with HCV, published in English, focused on U.S. populations, conducted from the payer perspective, reported results from a health economic model Supplemented PubMed search with a health technology assessment from the Institute for Clinical and Economic Review and a search of professional conference abstracts from ISPOR and the Academy of Managed Care Pharmacy 9

10 References Chhatwal J, Kanwal F, Roberts MS, et al. Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United States. Annals of Internal Medicine. 2015;162: Linas BP, Barter DM, Morgan JR, et al. The Cost-Effectiveness of Sofosbuvir-Based Regimens for Treatment of Hepatitis C Virus Genotype 2 or 3 Infection. Annals of Internal Medicine. 2015;162: Saab S, Gordon SC, Sulkowski M, et al. Cost-effectiveness analysis of sofosbuvir plus peginterferon/ribavirin in the treatment of chronic hepatitis C virus genotype 1 infection. Alimentary Pharmacology and Therapeutics. 2014;40: Younossi ZM, Park H, Saab S, et al. Cost-effectiveness of all-oral ledipasvir/sofosbuvir regimens in patients with chronic hepatitis C virus genotype 1 infection. Alimentary Pharmacology and Therapeutics. 2015;41: Gaitonde P, Yerlikaya NS, Chirikov VV, et al. Cost-effectiveness analysis of Sofosbuvir based combination therapies among patients with HCV infection. Poster presented at ISPOR 20 th Annual International Meeting, May 2015, Philadelphia, PA, USA. Tabano DC, Dilokthornsakul P, Campbell JD, et al. Cost Effectiveness of New Hepatitis C Therapies. Poster presented at ISPOR 20 th Annual International Meeting, May 2015, Philadelphia, PA, USA. Tice JA, Ollendorf DA, Chahal HS, et al. The Comparative Clinical Effectiveness and Value of Novel Combination Therapies for the Treatment of Patients with Genotype 1 Chronic Hepatitis C Infection. A Technology Assessment from the California Technology Assessment Forum, Completed by the Institute for Clinical and Economic Review. Final Report Released on January 30, Accessed at: 10