Weighing Clinical, Economical Benefits for Branded vs Generic HIV PrEP Therapies

Tenofovir alafenamide-emtricitabine (F/TAF) has proved to be a noninferior, potentially safer option than tenofovir disoproxil fumarate-emtricitabine (F/TDF) for HIV preexposure prophylaxis (PrEP), but researchers of a study published in Annals of Internal Medicine sought to examine its potential for cost savings and overall clinical benefit.

In a cost-effective analysis, Rochelle P Walensky, MD, MPH, Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard University Center for AIDS Research, Harvard Medical School, Boston, MA, and colleagues, examined 5 years of published literature on F/TDF safety, and the cost and quality-of-life of age stratified men who have sexual intercourse with other men and use PrEP.

The primary outcome measures included fractures averted, cases of ESRD averted, quality-adjusted life-years (QALYs) saved, costs, incremental cost-effectiveness ratios, and maximum justifiable price for F/TAF compared with generic F/TDF.

For the study’s five-year time horizon and 123,610 included patients, T/FAF averted 2101 fractures, 25 cases of ESRD, with an incremental cost-effectiveness ratio 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 researchers explained,  “the maximum fair price for F/TAF was $8670 per year.”

Results from a sensitivity analysis showed that, “Among persons older than 55 years, the incremental cost-effectiveness ratio 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.”

“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,” the researchers concluded.

This study was funded by the 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.

—Edan Stanley 

Reference:
Walensky RP, Horn T, McCann NC, Freedberg KA, Paltiel AD. Comparative Pricing of Branded Tenofovir Alafenamide-Emtricitabine Relative to Generic Tenofovir Disoproxil Fumarate-Emtricitabine for HIV Preexposure Prophylaxis: A Cost-Effectiveness Analysis [published online ahead of print, 2020 Mar 10]. Ann Intern Med. 2020;10.7326/M19-3478. doi:10.7326/M19-3478