Infusion Clinics Could Expand Utilization of Long-Acting Injectables, but Barriers Hinder Access

By: Ranier Simons, ADAP Blog Guest Contributor

The advent of long-acting injectables (LAI) for HIV prevention and treatment is a noteworthy breakthrough in medical science. Despite the growing number of options and continuing clinical studies showcasing their efficacy, they are under-utilized. While there are various drug-level and patient-level barriers to LAI uptake, one of the most significant barriers is access at the system level (Cooper et al., 2022). Many people who would greatly benefit from LAIs for prevention and people living with HIV/AIDS (PLWHA) in need of better options for treatment can’t access them. Logistics and coverage issues stand as obstacles to life-saving treatment and public health prevention.

Photo Source: HIV.gov

Discrepancies in insurance coverage constitute a significant barrier. In the U.S., 40 percent of PLWHA are insured by Medicaid, and 27 percent get medication from state AIDS Drug Assistance Programs (ADAP) (Zalla et al., 2025). A recent study examined prescription drug formulary coverage of long-acting cabotegravir/rilpivirine (CAB/RPV-LA) for HIV treatment for those who achieved viral suppression and lenacapivir (LEN) for adults with multi-drug-resistant strains. CAB/RPV-LA was not covered without prior authorization (PA) by 26 state Medicaid programs and had no coverage by 15 state ADAPs. LEN was not covered without prior authorization by 32 Medicaid programs and had no coverage by 18 ADAPs (Zalla et al., 2025). Eighteen state Medicaid plans had unencumbered uniform coverage of CAB/RPV-LA with no PA, and 11 had unencumbered uniform coverage of LEN with no PA (Zalla et al., 2025). A distinction is made between coverage with and without PA because prior authorizations for LAIs are particularly cumbersome. Additionally, many health insurers require reapproval processes for continued treatment.

Another recent study surveyed providers inquiring about identified barriers to LAI utilization for treatment and prevention regarding long-acting cabotegravir/rilpivirine (CAB/RPV-LA) for treatment and long-acting cabotegravir (CAB-LA) for HIV prevention (Marcus et al., 2025). These providers highlighted PA approval and appeals, re-verification of eligibility for continuous coverage, and coverage of LAIs as a medical benefit instead of a pharmacy benefit (Marcus et al., 2025).

Both studies highlight the central barrier of insurance bureaucracy as a hindrance to LAI access. Cumbersome PAs delay the initiation of treatment. Requiring re-verification of eligibility for treatment not only causes treatment delays but also adds to the administrative burden of providers (Marcus et al., 2025; Zalla et al., 2025). Providers cannot afford to be saddled with the extra administrative burden of soliciting and managing PAs or the financial expenditure of hiring staff for that purpose. Additionally, when LAIs are covered under insurance as a medical benefit instead of a pharmacy benefit, that can require a provider to purchase medications on the front end and bill the insurance on the back end in a “buy and bill” situation (Marcus et al., 2025). Not only is a financial investment for the medications required, but special storage and refrigeration is required. This may be logistically challenging and cost-prohibitive to a provider.

Photo Source: Pharmacy Practice News

When vulnerable patients rely on Medicaid or ADAPs to obtain LAIs, poor formulary coverage means a lack of access. Even if there is coverage, patients fall in and out of eligibility for Medicaid and ADAPs regularly due to income restrictions. When there is non-alignment of coverage between Medicaid and ADAP in a state, patients risk lengthy treatment interruptions. This is dangerous because LAIs remain in the body for long periods of time at low levels. As such, treatment interruptions can result in developing drug resistance (Zalla et al., 2025).

One solution to assist providers in avoiding some of the challenges of administering LAIs is referral to infusion clinics. Increasing the utilization of infusion clinics to administer LAIs would be an innovation of care delivery and implementation science from a process improvement perspective. As founder and CEO of Agile Infusion Services LLC, Yossi Faber states, “Freestanding ambulatory infusion clinics play a crucial role in expanding access to long-acting injectables for HIV prevention and treatment. However, without addressing systemic barriers such as restrictive insurance policies, provider education gaps, and operational constraints, these therapies won’t reach those who need them the most. Ensuring sustainable policies and adequate provider support is key to equitable access.”

Infusion centers that are not inside hospitals or other medical practices solely focus on infusion and injection therapies. Freestanding centers are in communities; thus, they are often more convenient for patients in terms of physical access. Additionally, the centers’ staff are highly trained with respect to injections and infusions. The advanced training increases patient safety and is a standard operational characteristic of their care model. They have lower overhead and can negotiate with payers at a lower price (Cheney, 2022).

Photo Source: Rx Toolkit

Primary care doctor offices and other medical clinics do not typically have the built-in workflow, refrigeration, and storage capacity, nor administrative capacity to effectively handle the utilization of LAIs. Infusion centers are experienced with the administrative navigation of prior approvals, medication handling, medication dispensing, and the logistics of obtaining drugs from specialty pharmacies. Moreover, primary care doctors are not well-versed on preventative LAIs. PLWHA utilize providers experienced with LAIs for their care. Those desiring LAIs for PrEP are typically unfamiliar with the HIV treatment landscape and have an unclear path to access. Faber explains, “This lack of awareness on the part of providers can result in significant underutilization of these therapies, as providers are often hesitant to recommend treatments with unfamiliar medications or modalities, particularly if they are unaware of where such therapies can be obtained.” Referring patients to infusion centers to administer LAIs for treatment and prevention is part of a comprehensive solution.

There is a dire need to improve access to long-acting injectable medications. Patients need to access many other beneficial therapies, such as Trogarzo, an LAI for treatment-resistant HIV, and Abilify Maintena for antipsychosis. Solutions to access issues require a multi-faceted approach. Policy intervention is necessary for insurers to streamline the PA process and remove the need for LAI reapproval. Congress should pass PrEP legislation to bolster assistance to people who are uninsured or underinsured. States should fund PrEP assistance programs. Congress should also increase funding for the Ryan White HIV/AIDS Program to help with the evolving demand for LAIs for treatment and prevention to make sure those vulnerable populations who can benefit the most are empowered with access. Medical science is evolving quickly. Thus, policy and funding innovation must also evolve to ensure equitable access to effective treatment for all.

[1] Cheney, C. (2022, August 3).Standalone Infusion Center CEO: 'The Patient Experience Is Superior.' Retrieved fromhttps://www.healthleadersmedia.com/clinical-care/standalone-infusion-center-ceo-patient-experience-superior#:~:text=Standalone%20infusion%20centers%20can%20offer,with%20lower%20overhead%20and%20expenses.

[2] Cooper, S. E., Rosenblatt, J., & Gulick, R. M. (2022). Barriers to Uptake of Long-Acting Antiretroviral Products for Treatment and Prevention of Human Immunodeficiency Virus (HIV) in High-Income Countries. Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 75(Suppl 4), S541–S548. https://doi.org/10.1093/cid/ciac716

[3] Lauren C Zalla, Tim Horn, Sita Lujintanon, Catherine R Lesko, State-Level Variation in Access to Long-Acting Injectable Antiretroviral Therapy for HIV in the United States, Health Affairs Scholar, 2025;, qxaf016, https://doi.org/10.1093/haschl/qxaf016

[4] Marcus, J. L., Weddle, A., Kelley, C. F., Agwu, A., Montalvo, S., Sherman, E., Vijayan, T., Gutierrez, J., Hickey, M. D., Dilworth, S. E., Krakower, D., Davis, T. L., Collins, L. F., McNulty, M. C., Colasanti, J. A., & Christopoulos, K. A. (2025). Policy recommendations to support Equitable access to Long-Acting Injectables for Human Immunodeficiency virus prevention and Treatment: A policy paper of the Infectious Diseases Society of America and the HIV Medicine Association. Clinical Infectious Diseases. https://doi.org/10.1093/cid/ciae648

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.