Background

In June 2025, the Meals and Drug Administration (FDA) authorised lenacapavir (Jeztugo) as the newest pre-exposure prophylaxis (PrEP) drug to forestall HIV in adults and adolescents. Lenacapavir is totally different from different obtainable PrEP merchandise. It’s the second long-acting injectable PrEP drug available on the market, however is dosed much less incessantly (twice a 12 months). Its comparatively rare dosing and excessive efficacy (100% for some populations) make it a promising possibility at a time when PrEP uptake stays stagnant in lots of areas and disparities persist.

This ACA open enrollment interval is the primary because the approval of lenacapavir, and a few customers could also be in search of market plans that cowl this era. Though lenacapavir is broadly thought-about a serious advance, early knowledge point out that insurance coverage protection and profit design selections could create obstacles to entry.

This temporary examines the challenges of assessing entry to PrEP in ACA market plans, however it’s possible that people face related challenges in different contexts, similar to assessing protection in employer, Medicare Half D, or Medicare Benefit plans.

Protection

Pharmacy profit supervisor (PPE) Selections

Pharmacy profit managers (PBMs) play a central position in figuring out which medication are coated in well being care plans. PBMs are impartial corporations that contract with plans to handle their pharmacy advantages. Amongst different doable roles, PBMs act as middlemen between drug producers and pharmacies, negotiating costs and finally figuring out prescription drug protection.

Specifically, PBM providers are concentrated amongst three corporations – CVS Caremark, Categorical Scripts and OptumRx – which collectively represented 73% of all business drug claims in 2023. Due to this fact, selections made by any of those entities might affect tens of millions of enrollees.

CVS Caremark, the biggest of the massive three (which accounts for 29% of the business market), doesn’t cowl lenacapavir. Based on media reviews, the corporate initially cited the necessity to discover “medical, monetary and regulatory concerns” and said in a latest electronic mail that value and ongoing negotiations with the producer, Gilead, had been a very powerful consideration. In the event you select to not cowl the drug, entry will probably be affected for anybody enrolled in a plan that makes use of CVS Caremark as a PBM, together with members in a market plan. In distinction, Gilead introduced throughout a third-quarter 2025 earnings name that Categorical Scripts (which captures 28% of the business market) is protecting the drug.

Preventive Companies Protection Below the ACA and the U.S. Preventive Companies Job Power (USPSTF) – Protection and Value Implications

The Inexpensive Care Act (ACA) requires most non-public medical insurance and Medicaid growth applications to cowl preventive providers advisable by the US Preventive Companies Job Power (USPSTF) – these receiving an ‘A’ or ‘B’ grade – with out value sharing. Moreover, the federal authorities later clarified that the protection necessities, along with drug protection, additionally embrace physician visits and related laboratory exams which might be further to PrEP.

The USPSTF gave PrEP an “A” advice, first in 2019 after which in an up to date advice in 2023, however even the later grade predated the approval of lenacapavir, and subsequently is just not explicitly included within the advice. In consequence, insurers or PBMs could make totally different selections about whether or not lenacapavir ought to be coated with out value sharing. If it isn’t labeled as an ACA-required preventive service, the drug could also be topic to copayments, coinsurance, deductibles, and even exclusion. Enrollees may incur prices for associated vendor visits and laboratory providers.

Whereas uncertainty stays, Gilead said in its Q3 2025 earnings name that the corporate had achieved 75% protection (together with amongst non-public and public payers) and that the majority payers are protecting the drug with out prior authorization or value sharing. At the very least some publishers who market merchandise in a number of states supply the drug as a preventive remedy with out value sharing and listing it of their formulations as a preventive drug (e.g., Oscar NY and IL and Molina in IL).

Whether or not and when the USPSTF will replace its PrEP advice stays unclear.

Medical vs Pharmacy Advantages

Most prescription drugs are coated by the pharmacy profit and are often collected from a bodily pharmacy or despatched to the enrollee by put up. Nonetheless, sure drugs, particularly these administered by a healthcare supplier, are billed as a medical profit.

Lenacapavir is provider-administered, and it seems that at the least some well being plans are protecting lenacapavir as a medical profit reasonably than a pharmacy profit. When this occurs, the drug could not seem in drug search instruments or on a plan’s kind, making it harder to find out protection.

For instance, in at the least two UnitedHealthcare markets (New York and Texas) the place plans use Optum as a PBM, the shape states that lenacapavir “is just not coated beneath your pharmacy profit and could also be coated beneath your medical plan. Please discuss with your well being plan identification card to find out subsequent steps or contact customer support.” As such, it would not be clear to a possible new entrant whether or not lenacapavir is roofed by the medical profit, though Gilead said on the earnings name that the issuer covers the drug.

Moreover, even when the plan states that lenacapavir is roofed as a medical profit, customers could not be capable of simply see how or if value sharing applies.

Market for drug discovery

Market plan search instruments differ in how and whether or not they show prescription drug protection. Some – together with the federal market – permit customers to test whether or not particular medication are coated by plans by way of search instruments or filters, whereas others, such because the New York market, don’t. Even when obtainable, the accuracy of those instruments could also be restricted.

For instance, within the federal market, search outcomes for Harris County, Texas point out that the Oscar plans don’t cowl lenacapavir, though the drug is listed on the issuer’s kind as a coated preventive drug.

In one other state of affairs, in Illinois, the state-based market device doesn’t choose up lenacapavir beneath the model or generic identify, regardless of some plan wordings indicating protection.

It’s doable that if lenacapavir is roofed as a medical profit and never on the normal kind, the protection info won’t be retrieved by the market plan’s drug discovery instruments, which is able to possible depend on kind knowledge.

Conventional obstacles to PrEP

Even when protection is accessible, long-standing obstacles to PrEP uptake stay and could also be elevated with lenacapavir. Lengthy-acting PrEP drugs particularly have introduced distinctive entry challenges. Suppliers usually should buy the drug upfront, retailer it, after which invoice for it after it’s administered – a apply generally known as “white bagging” – which may pose monetary and logistical hurdles, particularly for smaller clinics. Throughout its Q3 2025 earnings name, Gilead reported that almost all of lenacapavir prescribing is amongst skilled white-bagging PrEP prescribers.

Different persistent obstacles embrace restricted consciousness amongst suppliers and sufferers, stigma and discrimination associated to folks with HIV and LGBTQ+ populations, perceptions of HIV threat, variable consolation ranges with prescribing PrEP, supplier views of PrEP as outdoors their wheelhouse, and precise and perceived issues about value. Collectively, these components contribute to giant variations 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. Your personal prices can even kind a barrier. Analysis has proven that growing the out-of-pocket value for PrEP from $0 to $10 doubled the speed of unfilled prescriptions.

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 if handled and doubtlessly deadly if left untreated – and has public well being implications, decreasing transmission on the inhabitants stage. A latest research confirmed this, discovering that states with increased ranges of PrEP protection skilled higher declines in HIV diagnoses in comparison with states with decrease PrEP protection.

The approval of twice-yearly lenacapavir represents a brand new growth in HIV prevention efforts, however the extent of home adoption stays unsure.