Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis.

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.