access Uncertain for New Injectable PrEP as ACA Open Enrollment Begins
WASHINGTON – As the Affordable Care Act’s (ACA) Open Enrollment period begins, access to lenacapavir, a new twice-yearly injectable form of HIV pre-exposure prophylaxis (PrEP), remains unclear for many Americans despite some health plan formularies indicating coverage. Initial testing reveals that state-based marketplace tools do not currently retrieve lenacapavir data by either its brand or generic name, as of November 6, 2025.
This discrepancy may stem from lenacapavir being covered as a medical benefit rather than through customary pharmacy formularies,which are the primary data source for marketplace plan drug search tools.
Long-acting PrEP drugs like lenacapavir have historically faced access challenges. Providers frequently must purchase the medication upfront, store it, and bill for it after administration – a process known as “white bagging.” This creates financial and logistical burdens, particularly for smaller clinics. During Gilead’s Q3 2025 earnings call, the company reported that most lenacapavir prescriptions are currently being written by experienced PrEP prescribers utilizing the white bagging method.
Beyond coverage issues, longstanding barriers to PrEP uptake might potentially be amplified with lenacapavir. These include limited awareness among both providers and patients, stigma and discrimination affecting people with HIV and LGBTQ+ populations, perceptions of HIV risk, variable provider comfort levels prescribing prep, and both actual and perceived cost concerns. Research demonstrates the impact of cost, with a study showing that increasing out-of-pocket PrEP costs from $0 to $10 doubled the rate of prescriptions left unfilled.
Lack of clear coverage for long-acting 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 population level. A recent study found that states with higher PrEP coverage experienced larger decreases in HIV diagnoses compared to states with lower coverage.
The approval of twice-yearly lenacapavir represents a critically important advancement in HIV prevention, but its widespread adoption within the U.S. remains uncertain.
