Barriers to Long-Acting HIV Treatment Highlight Need for Policy Reform
Access to long-acting injectable antiretroviral therapy (LAI-ART) remains limited across the US despite its potential to improve adherence and outcomes for people with HIV, particularly those facing challenges with daily oral therapy. Two LAI-ART options are currently available: cabotegravir/rilpivirine (CAB/RPV) and lenacapavir (LEN). However, state-level coverage through Medicaid and AIDS Drug Assistance Programs (ADAPs) varies widely, leading to significant disparities in access among low-income and uninsured populations.
Although CAB/RPV received FDA approval in 2021 and is recommended in updated US Department of Health and Human Services (HHS) treatment guidelines, by early 2024, it was not covered on the formulary of 15 state ADAPs and required prior authorization (PA) in 7 additional states. Similarly, while LEN was approved in late 2022 and is the only capsid inhibitor currently available, it was not covered by 18 state ADAPs and required PA in three. These gaps are mirrored in Medicaid coverage: only 18 states provided uniform, PA-free access to CAB/RPV, while 26 required PA universally. LEN had even more restricted Medicaid access, with just 11 states offering uniform coverage without PA and 32 states requiring PA. The situation is exacerbated in non-expansion states like Texas and Florida, where many low-income adults are not eligible for Medicaid and cannot rely on ADAP to bridge coverage gaps.
These limitations have real consequences. In January 2024, nearly 20% of ADAP clients lived in states where CAB/RPV was not covered, with nearly half of those clients residing in Texas alone. Thirty-two percent of ADAP clients lived in states that did not cover LEN. Clients in states without formulary coverage were more likely to be living below the federal poverty level and, in the case of LEN, more likely to be Black. Disparities in coverage thus reflect and reinforce existing inequities in HIV care.
State ADAPs are statutorily required to include at least one drug from each antiretroviral class, which should mandate coverage of LEN. However, there is no requirement to include newer delivery forms such as CAB/RPV, and there is no time-bound expectation for states to update formularies. Meanwhile, HRSA has ceased active monitoring of ADAP formulary updates, leaving gaps in oversight. Medicaid, on the other hand, is obligated to cover all FDA-approved medications from manufacturers participating in the Medicaid Drug Rebate Program, but states retain discretion to implement utilization management strategies like PA, which can delay or discourage prescribing.
The consequences of these barriers are especially concerning given the pharmacokinetics of LAI-ART. Missed doses due to loss of coverage or PA-related delays could result in sub-therapeutic drug levels and contribute to the development of resistance. This is particularly risky for patients who initiate LAI-ART and then lose Medicaid coverage during a period of insurance churn. In states that lack ADAP coverage for LAI-ART, such as Louisiana, Ohio, and Oklahoma for CAB/RPV and several others for LEN, patients may have no path to maintain treatment.
There is an urgent need for federal leadership to address these access gaps. CMS could update guidance to states on equitable access to LAI-ART, emphasizing limitations on restrictive practices like PA. HRSA should consider reinstating performance measures that track the addition of new drugs to ADAP formularies and offer technical support to states. Partnerships between CMS and HRSA may help align Medicaid and ADAP policies, reducing disparities and ensuring that all people with HIV have access to a full range of effective treatment options, regardless of their income or insurance status.
As LAI-ART plays an increasing role in HIV treatment, minimizing administrative barriers and harmonizing coverage policies across payer types will be essential to achieving equitable access and improving outcomes for vulnerable populations.
Reference
Zalla LC, Horn T, Lujintanon S, Lesko CR. State-level variation in access to long-acting injectable antiretroviral therapy for HIV in the United States. Health Aff Sch. 2025;3(2):qxaf016. Published 2025 Jan 29. doi:10.1093/haschl/qxaf016
