New HIV Prevention Drug Faces Coverage Hurdles Despite Promising Results
Table of Contents
Despite the recent FDA approval of lenacapavir (Yeztugo) – a groundbreaking, twice-yearly injectable for HIV prevention – access to the drug is already proving complex, with insurance coverage and pharmacy benefit manager (PBM) decisions creating potential barriers for those who could benefit most.This challenge emerges during the first Affordable Care Act (ACA) open enrollment period since the drug’s approval in june 2025, raising concerns for consumers seeking plans that will cover this notable advancement in HIV prevention.
The approval of lenacapavir represents a major step forward in PrEP (pre-exposure prophylaxis) options, offering a less frequent dosing schedule than existing long-acting injectables and demonstrating high efficacy – even 100% in some populations. However, early indications suggest that translating this medical progress into widespread public health impact will depend on navigating a complicated insurance landscape.
The Role of Pharmacy Benefit Managers
Pharmacy benefit managers (PBMs) wield considerable power in determining which drugs health plans cover. Acting as intermediaries between drug manufacturers and pharmacies, these independent companies negotiate prices and ultimately dictate prescription medication coverage for millions of Americans. The PBM market is highly concentrated, with CVS Caremark, Express Scripts, and OptumRx controlling 73% of all commercial drug claims as of 2023.
This concentration of power means decisions made by any one of these entities can have far-reaching consequences. Currently, CVS Caremark, the largest PBM with a 29% market share, does not cover lenacapavir. According to reports, the company initially cited the need to investigate “clinical, financial, and regulatory considerations,” but has since indicated that price negotiations with gilead, the drug’s manufacturer, are the primary obstacle. This exclusion impacts all enrollees in plans utilizing CVS caremark as their PBM, including those enrolled in ACA marketplace plans.
Conversely,Gilead announced during its Q3 2025 earnings call that Express scripts,holding 28% of the commercial market,is covering the drug.
ACA Coverage and the USPSTF Advice
The Affordable Care Act (ACA) mandates that most private health insurance plans and Medicaid expansion programs cover preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) – those receiving an “A” or “B” grade – without cost-sharing. This coverage extends to physician visits and lab tests related to PrEP.
However,a critical ambiguity exists regarding lenacapavir’s coverage under the ACA. While the USPSTF gave PrEP an “A” recommendation in 2019 (updated in 2023), this recommendation predates the approval of lenacapavir and does not explicitly include it. This leaves room for insurers and PBMs to interpret whether lenacapavir qualifies for ACA-required,cost-free coverage. If not classified as a required preventive service, the drug could be subject to copayments, coinsurance, deductibles, or even outright exclusion, possibly impacting access for many.
Despite this uncertainty, Gilead reported achieving 75% coverage (across both private and public payers) as of its Q3 2025 earnings call. However, disparities in access remain, especially for individuals with limited insurance options or those relying on plans administered by PBMs like CVS Caremark.These factors contribute to significant disparities in PrEP uptake across different populations.
Implications for HIV Prevention
Lack of coverage for long-acting PrEP, or even a lack of clarity regarding coverage, could discourage its use. Research demonstrates that even a modest increase in out-of-pocket costs – from $0 to $10 – can double the rate of prescriptions left unfilled. access to PrEP is crucial for both individual and public health, protecting individual well-being and reducing HIV transmission rates at the population level. Studies have shown a correlation between higher PrEP coverage levels and larger decreases in HIV diagnoses.
The approval of twice-yearly lenacapavir represents a significant innovation in HIV prevention, but its ultimate impact remains uncertain. ensuring equitable access to this promising new tool will require ongoing vigilance and proactive efforts to address the coverage challenges that are already emerging.
