Q&A: Improving access to long-acting injectables for HIV prevention
Key takeaways:
- Results of an HIVMA survey outline barriers for implementing LAIs for HIV prevention.
- In response, HIVMA published suggestions to overcome these barriers.
A recent survey conducted by the HIV Medicine Association identified barriers to implementation of long-acting injectables for HIV prevention which included the need for prior authorization and funding issues.
“Long-acting modalities have been hailed as a potential game changer for HIV treatment and prevention, and the recent trials demonstrating high efficacy of lenacapavir for HIV prevention have renewed excitement about [long-acting injectables (LAIs)]” Colleen Kelley, MD, MPH, FIDSA, chair of the HIV Medicine Association, or HIVMA, and colleagues wrote in the paper. “However, efficacy is not sufficient for impact.”
Because of the “extremely limited” implementation of LAIs, the HIVMA conducted a survey to identify barriers to implementation.
Based on the survey’s results — which revealed barriers related to health insurance processes, staffing and administrative support and access for individuals who are uninsured — the team provided recommendations to improve broad and equitable access to LAIs for HIV prevention and treatment.
We asked Kelley why implementation has been limited, what the recommendations say and what more can be done to achieve the goals of the Ending the HIV Epidemic initiative.
Healio: What do the recommendations say?
Kelley: LAIs for HIV treatment and prevention offer great promise for people who face challenges with taking oral medications every day if there is broad and equitable access to them. The recommendations call for policy changes to realize the full potential of LAIs in advancing efforts to end the HIV epidemic in four key domains — health insurance processes, staffing and administrative support, drug costs and acquisition and access for uninsured individuals.
Healio: Why has implementation been “extremely limited?”
Kelley: HIV providers and potential users of LAIs highly anticipated their availability for HIV prevention and treatment, but offering them in practice required clinics to adapt in more ways than anticipated, including new insurance and purchasing processes, in addition to increased clinic visits and staffing capacity. Our survey found that the top barriers related to health insurance processes and, more specifically, to navigating the prior authorization processes required for a medical benefit rather than a pharmacy benefit. Many health plans cover LAIs as a medical benefit, as opposed to the pharmacy benefit like other HIV treatment and prevention options. The domain with the second most reported barriers was staffing and administrative issues and included staff for injection tracking, coordinating with specialty pharmacies and for injection visits.
Healio: What was the goal of the survey?
Kelley: HIVMA conducted the survey in response to member reports of significant challenges with implementing LAIs. Our goal was to identify and document barriers and facilitators to inform policy reforms that will facilitate the scale up of LAIs so they can realize their full potential to increase viral suppression rates for people with HIV and prevent new HIV infections for all people. We also hope the recommendations will inform implementation planning for the promising pipeline of LAI products.
Healio: Can you summarize the policy recommendations the paper suggests?
Kelley: The recommendations, developed before Jan. 20, 2025, call for new policies and funding to address the implementation barriers reported by providers and clinics.
In brief, to address the challenges posed by health insurance processes, we call for health plans to streamline approval processes and eliminate reapproval processes for LAIs and to allow for LAIs to be covered under either pharmacy or medical benefits.
To help address staffing issues, we recommend increasing funding for the Ryan White HIV/AIDS Program and the Community Health Center Program and funding for the Bio-Preparedness Workforce Pilot Program.
Recognizing the impact of drug costs on health insurance coverage and access issues, we also urge drug manufacturers to consider the importance of equitable access when setting the wholesale acquisition cost of HIV LAI products, allowing access outside of specialty pharmacies and offering public health prices for LAI products to health departments and others.
Finally, to improve access to those without insurance or with poor insurance coverage, we recommend that Congress pass legislation to close the Medicaid coverage gap; urge the state insurance commissioners and Centers for Medicaid and Medicare Services to enforce the requirements for coverage of preventive services, including PrEP, without cost sharing; and for states to fund state PrEP Assistance Programs.
HIVMA stands by these recommendations and will work strategically in collaboration with HIV community partners to advance policy change and ensure the sustainability of programs to improve access to HIV care and treatment, including LAIs.
Healio: What more can be done to achieve the goals of the Ending the HIV Epidemic initiative?
Kelley: The Ending the HIV Epidemic initiative and its goal of reducing new HIV infections by 90% by 2030 face serious threats. Although LAIs for HIV treatment and prevention are important tools to end the HIV epidemic, the programs that are the foundation of the HIV response in the United States and around the globe are at risk.
In the fiscal year 2025 federal funding bill, which as of this writing still has not been passed, federal HIV programs could be at risk for more than $700 million in cuts, including the complete elimination of Ending the HIV Epidemic Initiative funding.
On an even larger scale, funding for PEPFAR, the Medicaid program, CDC HIV, STI, viral hepatitis and tuberculosis prevention programs, the Ryan White HIV/AIDS Program, infectious diseases and HIV research and more, are unlikely to be immune to efforts to dramatically reduce federal funding in the absence of strong advocacy from the infectious disease and HIV community, including providers and researchers. I strongly encourage everyone to contact their members of Congress to educate them on the importance of these programs to your communities.
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