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Title: Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis.
Author: Walensky RP, Horn T, McCann NC, Freedberg KA, Paltiel AD.
Journal: Ann Intern Med; 2020 May 05; 172(9):583-590. PubMed ID: 32150602.
Abstract:
BACKGROUND: Tenofovir alafenamide-emtricitabine (F/TAF) was recently approved as a noninferior and potentially safer option than tenofovir disoproxil fumarate-emtricitabine (F/TDF) for HIV preexposure prophylaxis (PrEP) in the United States. OBJECTIVE: To estimate the greatest possible clinical benefits and economic savings attributable to the improved safety profile of F/TAF and the maximum price payers should be willing to pay for F/TAF over generic F/TDF. DESIGN: Cost-effectiveness analysis. DATA SOURCES: Published literature on F/TDF safety (in persons with and those without HIV) and the cost and quality-of-life effects of fractures and end-stage renal disease (ESRD). TARGET POPULATION: Age-stratified U.S. men who have sex with men (MSM) using PrEP. TIME HORIZON: Five years. PERSPECTIVE: Health care sector. INTERVENTION: Preexposure prophylaxis with F/TAF versus F/TDF. OUTCOME MEASURES: Fractures averted, cases of ESRD averted, quality-adjusted life-years (QALYs) saved, costs, incremental cost-effectiveness ratios (ICERs), and maximum justifiable price for F/TAF compared with generic F/TDF. RESULTS OF BASE-CASE ANALYSIS: Over a 5-year horizon, compared with F/TDF, F/TAF averted 2101 fractures and 25 cases of ESRD for the 123 610 MSM receiving PrEP, with an ICER of more than $7 million per QALY. At a 50% discount for generic F/TDF ($8300 per year) and a societal willingness to pay up to $100 000 per QALY, the maximum fair price for F/TAF was $8670 per year. RESULTS OF SENSITIVITY ANALYSIS: Among persons older than 55 years, the ICER for F/TAF remained more than $3 million per QALY and the maximum permissible fair price for F/TAF was $8970 per year. Results were robust to alternative time horizons and PrEP-using population sizes. LIMITATION: Intermittent use and on-demand PrEP were not considered. CONCLUSION: In the presence of a generic F/TDF alternative, the improved safety of F/TAF is worth no more than an additional $370 per person per year. PRIMARY FUNDING SOURCE: National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Massachusetts General Hospital Executive Committee on Research.

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