Addressing the Debate Regarding Coverage for PrEP

Insurance companies are currently investigating the option of modifying which medications they will cover for HIV pre-exposure prophylaxis (PrEP) therapy, with broad implications for patient access considering the limitations of the patient populations who will be able to use one of the drugs.

PrEP is a medication used to prevent HIV infection in patients most at risk of infection.¹ In October 2019, the FDA approved tenofovir alafenamide/emtricitabine (TAF/FTC, Descovy, Gilead Sciences) for PrEP;² however, recent research has challenged whether the medication is worth the price.²

The 2 FDA-approved medications for PrEP are tenofovir disoproxil fumarate/emtricitabine (TDF/FTC, Truvada, Gilead Sciences) and TAF/FTC.¹ TDF/FTC is approved for all adults and adolescents at risk of contracting HIV, whereas TAF/FTC has a more selective approval status.

Currently, TAF/FTC is approved for use by adults and adolescents, but not for adults and adolescents who are at risk of contracting HIV through vaginal sex.¹ This is due to its still pending approval by the FDA for protection against HIV transmission through vaginal sex. An additional difference between the 2 drugs is that TAF/FTC showed more positive effects on bone mineral density and kidney safety than TDF/FTC.³

The debate over drug insurance companies covering 1 of these drugs but not both has potentially far reaching implications. Since the 2 drugs have not been tested and approved for use among the same populations, making comparisons between the 2 becomes challenging.

In an article published in Annals of Internal Medicine, the authors explained, “It would be a clinical leap of faith to use TAF/FTC instead of TDF/FTC in other populations.”⁴

The authors also noted that in the future, in order to avoid this issue, no HIV prevention drug should be allowed to undergo FDA review without first testing the drug among all key populations at risk for HIV.⁴

Another factor to consider in the debate regarding which drug should be covered is there are already hundreds of thousands of people taking TDF/FTC.⁴ Switching these patients to another medication might disrupt adherence and have other unforeseen consequences, including cost considerations.

Currently, PrEP therapy with TDF/FTC is approximately $24,000 a year. TDF/FTC is scheduled to have a generic released later this year, which should be more cost-effective, but this has not yet occurred while the debate regarding coverage continues.⁴

In order to address this debate, 1 insurance company has already made their decision. UnitedHealthcare announced starting September 1, 2020, that TDF/FTC will be the only covered medication for PrEP until a generic hits the market.² In light of this decision, it may be possible that the pressure to save money will force other insurance companies to follow suit in the coming months.

REFRENCES

• U.S. Department of Health & Human Services. Using HIV Medication to Reduce Risk: Pre-Exposure Prophylaxis. HIV.gov. Published 2020. hiv.gov/hiv-basics/hiv-prevention/using-hiv-medication-to-reduce-risk/pre-exposure-prophylaxis#:~:text=Approved%20for%20PrEP%3F,Currently%2C%20there%20are%20only%20two%20FDA%2Dapproved%20medications%20for%20PrEP,the%20brand%20name%20Descovy%C2%AE. Accessed September 14, 2020.
• Haefner M. United Healthcare changes coverage for Gilead’s new HIV prevention drug. Becker’s Hospital Review. 2020. beckershospitalreview.com/payer-issues/unitedhealthcare-changes-coverage-for-gilead-s-new-hiv-prevention-drug.html. Accessed September 14, 2020.
• Mayer K H, Molina JM, Thompson MA, et al. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. The Lancet. 2020. thelancet.com/journals/lancet/article/PIIS0140-6736(20)31065-5/fulltext. Accessed September 14, 2020.
• Shaw M. In Debate Over PrEP, Researchers Raise Question About Benefit vs Value. AJMC. 2020. ajmc.com/view/in-debate-over-prep-researchers-raise-questions-about-benefit-vs-value-. Accessed September 14, 2020.