Rochelle P. Walensky, MD, MPH; Tim Horn, MS; Nicole C. McCann, BA; Kenneth A. Freedberg, MD, MSc; A. David Paltiel, MBA, PhD
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Massachusetts General Hospital Executive Committee on Research.
Financial Support: By the National Institute of Allergy and Infectious Diseases (R01 AI042006), National Institute on Drug Abuse (R37 DA015612), and National Institute of Mental Health (R01 MH105203), and the Massachusetts General Hospital Executive Committee on Research (Steve and Deborah Gorlin Research Scholars Award to Dr. Walensky).
Disclosures: Dr. Walensky reports grants from the National Institute of Allergy and Infectious Diseases (NIAID) and the Massachusetts General Hospital Executive Committee on Research: Steve and Deborah Gorlin Research Scholars Award during the conduct of the study. Dr. Freedberg reports grants from NIAID during the conduct of the study and grants from NIAID, the French National Agency for Research on AIDS, UNITAID, and the National Institute of Mental Health (NIMH) outside the submitted work. Ms. McCann reports grants from NIAID during the conduct of the study. Dr. Paltiel reports grants from National Institute on Drug Abuse and NIMH during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-3478.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Christina C. Wee, MD, MPH, Deputy Editor, reports employment with Beth Israel Deaconess Medical Center. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Yu-Xiao Yang, MD, MSCE, Deputy Editor, reports that he has no financial relationships or interest to disclose.
Reproducible Research Statement: Study protocol: None required. Statistical code: Portions are available through written agreements by contacting Dr. Walensky (e-mail, firstname.lastname@example.org) and Dr. Paltiel (e-mail, email@example.com). Data set: All data used in this analysis were obtained from publicly available, published, or online sources. The relevant publication and URLs for each source appear in the References section.
Corresponding Author: Rochelle P. Walensky, MD, MPH, Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit Street, Bul 130, Boston, MA 02114; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Walensky: Division of Infectious Diseases, Massachusetts General Hospital, 55 Fruit Street, GJ504, Boston, MA 02114.
Mr. Horn: National Alliance of State and Territorial AIDS Directors, 444 North Capitol Street NW, Suite 339, Washington, DC 20001.
Ms. McCann and Dr. Freedberg: Medical Practice Evaluation Center, 100 Cambridge Street, Boston, MA 02114.
Dr. Paltiel: Yale School of Public Health, 60 College Street, New Haven, CT 06510.
Author Contributions: Conception and design: R.P. Walensky, A.D. Paltiel.
Analysis and interpretation of the data: R.P. Walensky, N.C. McCann, K.A. Freedberg, A.D. Paltiel.
Drafting of the article: R.P. Walensky.
Critical revision of the article for important intellectual content: R.P. Walensky, T. Horn, K.A. Freedberg, A.D. Paltiel.
Final approval of the article: R.P. Walensky, T. Horn, N.C. McCann, K.A. Freedberg, A.D. Paltiel.
Statistical expertise: R.P. Walensky.
Obtaining of funding: R.P. Walensky, K.A. Freedberg, A.D. Paltiel.
Administrative, technical, or logistic support: N.C. McCann.
Collection and assembly of data: R.P. Walensky, A.D. Paltiel.
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.
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.
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 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.
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.
Walensky RP, Horn T, McCann NC, et al. Comparative Pricing of Branded Tenofovir Alafenamide–Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate–Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis. Ann Intern Med. 2020;:. [Epub ahead of print 10 March 2020]. doi: https://doi.org/10.7326/M19-3478
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Published: Ann Intern Med. 2020.
Healthcare Delivery and Policy, HIV, Infectious Disease, Prevention/Screening.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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