Access Uncertain for New Injectable PrEP as the Affordable Care Act’s (ACA) Open Enrollment Begins

Background

In June 2025, the Food and Drug Administration (FDA) approved lenacapavir (Yeztugo) as the latest pre-exposure prophylaxis (PrEP) drug to prevent HIV in adults and adolescents. Lenacapavir differs from other available PrEP products. It is the second long-acting injectable PrEP drug on the market but offers less frequent (twice annual) dosing. Its relatively infrequent dosing and its high efficacy (100% for some populations) make it a promising option at a time when PrEP uptake has continued to stall in many regions and disparities persist. 

This ACA open enrollment period is the first since lenacapavir’s approval, and some consumers may be looking for marketplace plans that cover it. However, despite lenacapavir widely being considered a major advance, early evidence suggests that insurance coverage and benefit design decisions may create barriers to access.

This brief examines challenges in assessing access to PrEP in ACA marketplace plans but it is likely that individuals would face similar challenges in other contexts, such assessing coverage in employer, Medicare Part D, or Medicare Advantage plans.

Coverage

Pharmacy Benefit Manager (PBM) Decisions

Pharmacy benefit managers (PBMs) play a central role in determining which drugs health plans cover. PBMs are independent companies that contract with plans to manage their pharmacy benefits. In addition to other possible roles, PBMs act as an intermediary between drug manufacturers and pharmacies, negotiating prices and ultimately determining enrollee prescription medication coverage. 

Notably, PBM services are concentrated with three companies —CVS Caremark, Express Scripts, and OptumRx— which together represented 73% of all commercial drug claims in 2023. Therefore, decisions by any one of these entities stand to affect millions of enrollees.

CVS Caremark, the largest of the big three (capturing 29% of the commercial market), does not cover lenacapavir. According to media reports the company initially cited needing to investigate “clinical, financial, and regulatory considerations” and in a recent email stated that price, and continued negotiations with its manufacturer, Gilead, was the main consideration. Choosing not to cover the drug has access implications to all those enrolled in plans using CVS Caremark as its PBM, including for marketplace plan enrollees. By contrast, during a Q3 2025 earnings call Gilead announced that Express Scripts (capturing 28% of the commercial market) is covering the drug.

Preventive Services Coverage Under the ACA & the U.S. Preventive Services Task Force (USPSTF) – Coverage and Cost Implications

The Affordable Care Act (ACA) requires most private health insurance plans and Medicaid expansion programs to cover preventive services recommended by the U.S. Preventive Services Task Force (USPSTF) – those receiving an “A” or “B” grade – without cost-sharing. In addition, the federal government later clarified that along with covering the drug, the coverage requirements encompass physician visits and associated lab tests ancillary to PrEP.

The USPSTF gave PrEP an “A” recommendation, first in 2019 and then in an updated recommendation in 2023, but even the later grade predated the approval of lenacapavir, and therefore the recommendation does not explicitly include it. As a result, insurers or PBMs may make different determinations about whether lenacapavir must be covered without cost-sharing. If it is not classified as an ACA-required preventive service, the drug could be subject to copayments, coinsurance, deductibles, or even exclusion. Enrollees could also face costs for related provider visits and laboratory services.

While uncertainty remains, in its Q3 2025 earnings call Gilead stated that the company had achieved 75% coverage (including among private and public payers) and that most payers are covering the drug without prior authorization or cost-sharing. Indeed, at least some issuers offering marketplace products in multiple states are offering the drug with zero cost-sharing as preventive medication, listing it in their formularies as a preventive drug (e.g. Oscar NY and IL and Molina in IL).

Whether or when the USPSTF will update its PrEP recommendation remains unclear.

Medical vs. Pharmacy Benefits

Most prescription medications are covered under the pharmacy benefit and typically picked up at a brick-and-mortar pharmacy or mailed to the enrollee. However, certain drugs, particularly those that are administered by a health care provider, are billed as a medical benefit.

Lenacapavir is provider administered and it appears at least some health plans might be covering lenacapavir as medical benefit rather than as a pharmacy benefit. When this happens, the drug may not appear in drug-search tools or on a plan’s formulary, making coverage more difficult to determine.

For example, in at least two UnitedHealthcare markets (New York and Texas), where plans use Optum as a PBM, the formulary states that lenacapavir “is not covered under your Pharmacy Benefit and may be covered under your Medical Policy. Please refer to your health plan ID card to determine next steps or contact customer service.” As such for a potential new enrollee, it would not be clear if lenacapavir is covered under the medical benefit, though on the earnings call Gilead stated the issuer is covering the drug. 

Further, even if a plan states lenacapavir is covered as a medical benefit, consumers may not easily be able to see how and if cost-sharing applies.

Marketplace Drug Search Tools

Marketplace plan search tools vary in how and if they display prescription drug coverage. Some – including the federal marketplace- allow users to check whether specific medications are covered by plans through search tools or filters, while others, like New York’s marketplace, do not. Even when available, the accuracy of these tools may be limited.

For instance, on the federal marketplace, search results for Harris County, Texas indicate Oscar plans do not cover lenacapavir, though the drug appears on the issuer formulary as a covered preventive drug.

In another scenario, in Illinois, the state-based marketplace tool does not retrieve lenacapavir by either its brand or generic name, despite some plan formularies indicating coverage.

It is possible that if lenacapavir is covered as a medical benefit and not on the traditional formulary, coverage information will not be pulled in by the marketplace plan drug search tools which are likely to rely on formulary data.  

Traditional Barriers to PrEP

Even when coverage is available, longstanding barriers to PrEP uptake persist and may be magnified with lenacapavir. Long-acting PrEP drugs, in particular, have presented unique access challenges. Providers often must purchase the drug upfront, store it, and then bill for it after it is administered—a practice known as “white bagging”—which can create financial and logistical hurdles, especially for smaller clinics. Indeed, on the Q3 2025 earnings call, Gilead reported that most lenacapavir prescribing is occurring among experienced PrEP prescribers using white bagging.

Other persistent barriers include limited awareness among providers and patients, stigma and discrimination related to people with HIV and LGBTQ+ populations, perceptions of HIV risk, variable provider comfort level prescribing PrEP, provider’s viewing PrEP as outside of their wheelhouse, and actual and perceived cost concerns. Together, these factors contribute to wide disparities in PrEP uptake.

Implications for HIV Prevention

Lack of coverage of long-acting PrEP, or even lack of clarity about coverage, could discourage its use. Out-of-pocket costs could be a barrier as well. Research has shown that increasing the out-of-pocket costs for PrEP from $0 to $10 doubled the rate at which prescriptions went unfilled.

Access to PrEP has implications for both individual and public health. Preventing HIV transmission protects individual health—HIV is a lifelong condition when treated and potentially fatal when untreated—and has an impact on public health, reducing transmission at the population level. A recent study demonstrated this, finding that states with higher levels of PrEP coverage had larger decreases in HIV diagnoses compared to states with lower levels of PrEP coverage.

The approval of twice-yearly lenacapavir represents a novel development in HIV prevention efforts, but the extent of domestic uptake remains uncertain.