• Rochelle P Walensky, Tim Horn, Nicole C McCann, Kenneth A Freedberg, and A David Paltiel.
• Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard University Center for AIDS Research, Harvard Medical School, Boston, Massachusetts (R.P.W.).
• Ann. Intern. Med. 2020 May 5; 172 (9): 583590583-590.

BackgroundTenofovir 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.ObjectiveTo 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.DesignCost-effectiveness analysis.Data SourcesPublished 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 PopulationAge-stratified U.S. men who have sex with men (MSM) using PrEP.Time HorizonFive years.PerspectiveHealth care sector.InterventionPreexposure prophylaxis with F/TAF versus F/TDF.Outcome MeasuresFractures 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 AnalysisOver 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 AnalysisAmong 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.LimitationIntermittent use and on-demand PrEP were not considered.ConclusionIn 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 SourceNational 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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