Brief Report: To Err Is Human, to Persist Is Diabolical: Are We Repeating the Same Cost and Insurance Coverage Mistakes Again With Injectable PrEP?

Abstract

Background: Long-acting injectable pre-exposure prophylaxis (PrEP) is the most promising biomedical HIV prevention innovation since the release of oral PrEP in 2012, but its reach may be undermined by inadequate access. The high list price of injectable PrEP has been cited as a critical driver of access issues for cabotegravir-formulated injectable PrEP, challenges that are likely to persist for the recently approved, twice-yearly injectable PrEP drug, lenacapavir. In this Viewpoint piece, we argue that now is the time to take stock of our recent progress with the rollout of injectable cabotegravir to learn from our mistakes for lenacapavir for PrEP.

Setting: An online, US national cohort study of sexual and gender minority individuals that are vulnerable to HIV.

Methods: We report preliminary longitudinal data (2022-2025) on interest in and uptake of long-acting injectable cabotegravir.

Results: During their first assessment, 61% reported that they were either "somewhat interested" or "very interested" in bimonthly injectable PrEP. However, by their 12-month assessment, only 42 individuals had taken up injectable PrEP, and at their 24-month assessment 57 individuals were on injectable PrEP. Participants reported several challenges when beginning and maintaining access to injectable PrEP, including challenges at the provider and clinic-level, and regarding insurance coverage and payment/cost issues.

Conclusions: Emerging data suggest high interest in injectable PrEP but low uptake, with some participants reporting challenges obtaining insurance coverage, alongside other clinic-level barriers. It is our hope that assessments of current and persisting barriers to cabotegravir can offer preliminary but critical insights for the rollout of lenacapavir.

Keywords: HIV prevention; PrEP; USPSTF; drug pricing; health insurance.