Background
In June 2025, the Meals and Drug Administration (FDA) permitted lenacapavir (Yeztugo) as the most recent pre-exposure prophylaxis (PrEP) drug to forestall HIV in adults and adolescents. Lenacapavir differs from different obtainable PrEP merchandise. It’s the second long-acting injectable PrEP drug available on the market however presents much less frequent (twice annual) dosing. Its comparatively rare dosing and its excessive efficacy (100% for some populations) make it a promising choice at a time when PrEP uptake has continued to stall in lots of areas and disparities persist.
This ACA open enrollment interval is the primary since lenacapavir’s approval, and a few customers could also be in search of market plans that cowl it. Nevertheless, regardless of lenacapavir broadly being thought-about a significant advance, early proof means that insurance coverage protection and profit design selections could create obstacles to entry.
This transient examines challenges in assessing entry to PrEP in ACA market plans however it’s probably that people would face comparable challenges in different contexts, such assessing protection in employer, Medicare Half D, or Medicare Benefit plans.
Protection
Pharmacy Profit Supervisor (PBM) Choices
Pharmacy profit managers (PBMs) play a central position in figuring out which medication well being plans cowl. PBMs are impartial firms that contract with plans to handle their pharmacy advantages. Along with different attainable roles, PBMs act as an middleman between drug producers and pharmacies, negotiating costs and in the end figuring out enrollee prescription medicine protection.
Notably, PBM providers are concentrated with three firms —CVS Caremark, Specific Scripts, and OptumRx— which collectively represented 73% of all commercial drug claims in 2023. Subsequently, selections by any one in every of these entities stand to have an effect on thousands and thousands of enrollees.
CVS Caremark, the most important of the large three (capturing 29% of the industrial market), doesn’t cowl lenacapavir. In response to media reports the corporate initially cited needing to analyze “medical, monetary, and regulatory concerns” and in a latest e mail said that value, and continued negotiations with its producer, Gilead, was the primary consideration. Selecting to not cowl the drug has entry implications to all these enrolled in plans utilizing CVS Caremark as its PBM, together with for market plan enrollees. Against this, throughout a Q3 2025 earnings call Gilead introduced that Specific Scripts (capturing 28% of the commercial market) is masking the drug.
Preventive Providers Protection Below the ACA & the U.S. Preventive Providers Process Drive (USPSTF) – Protection and Value Implications
The Reasonably priced Care Act (ACA) requires most personal medical insurance plans and Medicaid enlargement packages to cowl preventive services really helpful by the U.S. Preventive Providers Process Drive (USPSTF) – these receiving an “A” or “B” grade – with out cost-sharing. As well as, the federal authorities later clarified that together with masking the drug, the protection necessities embody doctor visits and related lab exams ancillary to PrEP.
The USPSTF gave PrEP an “A” recommendation, first in 2019 after which in an up to date suggestion in 2023, however even the later grade predated the approval of lenacapavir, and subsequently the advice doesn’t explicitly embody it. In consequence, insurers or PBMs could make completely different determinations about whether or not lenacapavir have to be lined with out cost-sharing. If it’s not categorized as an ACA-required preventive service, the drug could possibly be topic to copayments, coinsurance, deductibles, and even exclusion. Enrollees might additionally face prices for associated supplier visits and laboratory providers.
Whereas uncertainty stays, in its Q3 2025 earnings call Gilead said that the corporate had achieved 75% protection (together with amongst personal and public payers) and that the majority payers are masking the drug with out prior authorization or cost-sharing. Certainly, at the least some issuers providing market merchandise in a number of states are providing the drug with zero cost-sharing as preventive medicine, itemizing it of their formularies as a preventive drug (e.g. Oscar NY and IL and Molina in IL).
Whether or not or when the USPSTF will replace its PrEP suggestion stays unclear.
Medical vs. Pharmacy Advantages
Most prescription drugs are lined below the pharmacy profit and sometimes picked up at a brick-and-mortar pharmacy or mailed to the enrollee. Nevertheless, sure medication, notably these which can be administered by a well being care supplier, are billed as a medical profit.
Lenacapavir is supplier administered and it seems at the least some well being plans is likely to be masking lenacapavir as medical profit fairly than as a pharmacy profit. When this occurs, the drug could not seem in drug-search instruments or on a plan’s formulary, making protection tougher to find out.
For instance, in at the least two UnitedHealthcare markets (New York and Texas), the place plans use Optum as a PBM, the formulary states that lenacapavir “shouldn’t be lined below your Pharmacy Profit and could also be lined below your Medical Coverage. Please seek advice from your well being plan ID card to find out subsequent steps or contact customer support.” As such for a possible new enrollee, it could not be clear if lenacapavir is roofed below the medical profit, although on the earnings name Gilead said the issuer is masking the drug.
Additional, even when a plan states lenacapavir is roofed as a medical profit, customers could not simply be capable to see how and if cost-sharing applies.
Market Drug Search Instruments
Market plan search instruments range in how and in the event that they show prescription drug protection. Some – together with the federal marketplace- enable customers to test whether or not particular drugs are lined by plans via search instruments or filters, whereas others, like New York’s market, don’t. Even when obtainable, the accuracy of those instruments could also be restricted.
For example, on the federal market, search outcomes for Harris County, Texas point out Oscar plans don’t cowl lenacapavir, although the drug seems on the issuer formulary as a lined preventive drug.
In one other situation, in Illinois, the state-based market instrument doesn’t retrieve lenacapavir by both its model or generic identify, regardless of some plan formularies indicating protection.
It’s attainable that if lenacapavir is roofed as a medical profit and never on the standard formulary, protection data is not going to be pulled in by {the marketplace} plan drug search instruments that are prone to depend on formulary information.
Conventional Obstacles to PrEP
Even when protection is offered, longstanding obstacles to PrEP uptake persist and could also be magnified with lenacapavir. Lengthy-acting PrEP medication, particularly, have offered distinctive entry challenges. Suppliers typically should buy the drug upfront, retailer it, after which invoice for it after it’s administered—a observe often called “white bagging”—which may create monetary and logistical hurdles, particularly for smaller clinics. Certainly, on the Q3 2025 earnings call, Gilead reported that the majority lenacapavir prescribing is going on amongst skilled PrEP prescribers utilizing white bagging.
Different persistent obstacles embody restricted consciousness amongst suppliers and sufferers, stigma and discrimination associated to folks with HIV and LGBTQ+ populations, perceptions of HIV threat, variable supplier consolation stage prescribing PrEP, supplier’s viewing PrEP as exterior of their wheelhouse, and actual and perceived cost issues. Collectively, these elements contribute to extensive disparities in PrEP uptake.
Implications for HIV Prevention
Lack of protection of long-acting PrEP, and even lack of readability about protection, might discourage its use. Out-of-pocket prices could possibly be a barrier as effectively. Analysis has shown that growing the out-of-pocket prices for PrEP from $0 to $10 doubled the speed at which prescriptions went unfilled.
Entry to PrEP has implications for each particular person and public well being. Stopping HIV transmission protects particular person well being—HIV is a lifelong situation when handled and probably deadly when untreated—and has an impression on public well being, lowering transmission on the inhabitants stage. A recent study demonstrated this, discovering that states with greater ranges of PrEP protection had bigger decreases in HIV diagnoses in comparison with states with decrease ranges of PrEP protection.
The approval of twice-yearly lenacapavir represents a novel growth in HIV prevention efforts, however the extent of home uptake stays unsure.
Word: The outline of market searches befell on 11/6/2025.
