Abstract
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. 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. Cost-effectiveness analysis. 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). Age-stratified U.S. men who have sex with men (MSM) using PrEP. Five years. Health care sector. Preexposure prophylaxis with F/TAF versus F/TDF. 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. Over a 5-year horizon, compared with F/TDF, F/TAF averted 2101 fractures and 25 cases of ESRD for the 123610 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 $100000 per QALY, the maximum fair price for F/TAF was $8670 per year. 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. Intermittent use and on-demand PrEP were not considered. 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. 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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