access Uncertain for New Injectable PrEP as ACA Openโ Enrollment Begins
WASHINGTON – As the Affordable Care Act’s (ACA)โฃ Open Enrollmentโฃ period โbegins, access to lenacapavir, โa new twice-yearly injectable formโ of HIV pre-exposure prophylaxis (PrEP), remains unclear โfor many Americans despite some health plan โformularies indicating coverage.โ Initial testing reveals that state-based marketplace โtools โฃdoโค not currently retrieve lenacapavir data by either โคits brandโ or generic โฃname, โas of November 6, 2025.
This discrepancy may stem from lenacapavirโฃ being covered as a medical benefit rather than throughโ customary pharmacy formularies,which are theโข primary data source for marketplace plan drug search tools.
Long-acting PrEP drugs like lenacapavir โhave historically faced access challenges. Providersโ frequently must purchase the โฃmedication upfront, store it, and bill forโฃ it after administration – a process knownโข as “white bagging.” This creates financial and โฃlogistical burdens, โparticularly โฃforโ smaller clinics. During Gilead’s Q3 2025 earnings call, theโฃ company reported that most lenacapavir prescriptions are currently being written by experienced โฃPrEP prescribers utilizing โขthe white bagging method.
Beyond โคcoverageโข issues, longstanding barriers to PrEP โuptake โmight potentially be amplified with lenacapavir. These include limited awareness among โboth providers and patients, stigma and discriminationโ affecting people with HIV and LGBTQ+ populations, โperceptions of HIV risk, โvariable provider comfort levels prescribing prep, and both actual and perceived cost concerns. Research demonstrates the impact ofโ cost, with a study โขshowing that increasing out-of-pocket PrEP โคcosts from $0 to $10 doubled the rate of prescriptions leftโ unfilled.
Lack of clear coverage โfor long-actingโ PrEP could discourage its use. Access to PrEP is critical for both individual and public health, preventing HIV transmission and reducing infection rates at the โคpopulation level. A โrecent study found that states with higher PrEP coverage โexperienced larger decreases in โคHIV โขdiagnoses compared to states with lower coverage.
The approval โof twice-yearly lenacapavir represents a critically โimportantโค advancement in HIV prevention, but its widespread adoption within the U.S. remains uncertain.
