PACHA’s March 2021 meeting highlighted disparities in access to HIV treatment and prevention products, calling for equitable access to pre-exposure prophylaxis (PrEP) products and ancillary services for high-risk populations.¹ President Biden has expressed a commitment to ending HIV transmission in the US by 2025 through ongoing HIV prevention efforts within federal agencies.² Inequities in access to HIV prevention products across high-risk populations has led to increasing racial and gender-related disparities in HIV incidence, transmission, and viral suppression related to social determinants of health (SDoH). The success of the National Strategic Plan to End HIV by 2025 will depend upon increasing access to PrEP products and ancillary services for vulnerable populations with a key focus on affordability of these preventive products through continued coverage reform.

Background

In 2019, the US Preventive Services Task Force (USPSTF) gave a Grade A recommendation to PrEP products for the prevention of HIV infection for persons at high risk of HIV acquisition.³  Under the Affordable Care Act, products with a USPSTF Grade A or B recommendation must be covered without cost-sharing in the commercial and Medicaid expansion markets. While this coverage requirement officially took effect on January 1, 2021, many stakeholders are still awaiting clarifying enforcement guidance from the Center for Consumer Information and Insurance Oversight (CCIIO) regarding PrEP coverage requirements, including what must be covered, requirements for ancillary services, and the limitations on applicability of utilization management. In addition to clarifying guidance in the short term, the market for PrEP is likely to evolve in the coming years with new products, different mechanisms of action, and coverage expansions. Ensuring that these developments reduce barriers to access, mitigate health disparities, and increase uptake will be crucial to ending transmission of HIV in the US.

Details

Disparities in HIV inequity are caused by multiple factors, including socioeconomic status, insurance status, and geographic proximity to comprehensive care, as well as cultural stigma and overlapping behavioral risk factors (e.g., intravenous drug use). Differences in PrEP use between high- and low-risk populations may exacerbate disparities in the burden of HIV and require policymakers’ attention. Research from the Infectious Diseases Society of America has shown that despite equal levels of willingness to use PrEP between Black and White men who have sex with men (MSM), PrEP use was significantly higher among White MSM; in 2017, 5.9% of at-risk Black individuals were on PrEP, compared to 42.1% of at-risk White individuals.^4,5

Other factors that contribute to disparities in PrEP utilization include lack of access to ancillary services, limited knowledge and awareness of PrEP for both patients and providers, individual perception of risk, and social stigma.^6,7 Despite high community prevalence, young Black MSM were 10% less likely in 2014 to have an indication for PrEP relative to young non-Black MSM.⁴ Multiple analyses have found that Black MSM are less likely to report risk behaviors and, subsequently, less likely to have indications for PrEP under current guidelines.^4,8 In response to disparities in prevalence of PrEP indications, clinicians have been advised to consider non-behavioral factors when prescribing PrEP, such as poverty, racial discrimination, and community prevalence of HIV. Additionally, individuals who live in states that have not expanded Medicaid may face additional challenges in accessing PrEP based on their insurance status, as cost-sharing requirements remain a roadblock for low-income populations at risk for HIV infection.

The COVID-19 pandemic has posed additional challenges to HIV prevention and exacerbated existing health care disparities. According to multiple studies, people living with HIV experience poorer COVID-19-related outcomes, including delayed diagnosis, higher rates of hospitalization, and increased mortality rates.⁹ Additional challenges to PrEP product access and adherence have also emerged for those at increased risk of HIV transmission related to the current public health emergency. Stakeholders have adapted to current restrictions on social distancing during the pandemic through expanded use of at-home HIV and sexually transmitted disease testing, telehealth visits, and online prescribing of PrEP products. However, access to these new technologies is unequal and difficult for poorer and more rural poor populations.

Policy Landscape

In addition to guidance from CCIIO, current legislative proposals may reshape the landscape for PrEP product access. The PrEP Access and Coverage Act—originally proposed in 2019 by then-Senator Kamala Harris—would federally mandate PrEP coverage and ancillary services.¹⁰ This legislation would:

1. Require health insurance plans to cover prescription drugs that prevent HIV transmission, as well as related screenings, diagnostics and clinical follow-up with no cost sharing
2. Prohibit denying insurance or increasing premiums for those taking PrEP
3. Direct the US Department of Health and Human Services to award grants to local organizations to help provide uninsured individuals access to prescription drugs and related services

Codifying coverage and access requirements through federal law would help reduce access disparities related to ambiguities in coverage requirements across states and could also strengthen CCIIO’s final recommendations for enforcement of coverage. Other efforts to provide free PrEP coverage have encountered barriers from a lack of mandated coverage requirements. The federally run Ready, Set, PrEP Program, started in 2019, provides free medication to those without prescription drug coverage but does not provide related clinic visits and lab test costs, which has limited its effectiveness.¹¹ As of June 2020, only 891 patients were enrolled in the Ready, Set, PrEP Program, significantly behind the Trump Administration’s target of 200,000 participants to meet the program’s HIV prevention goals by 2030.¹²

Looking Ahead

Achieving the administration’s goal of ending HIV transmission by 2025 will require a substantial increase in both PrEP product and ancillary service utilization, awareness of barriers, and identification of solutions to address the significant disparities in access. Stakeholders interested in expanding PrEP coverage and access can advocate at the federal, state, and local levels for expanded access to a variety of PrEP products and funding opportunities, organize internally for upcoming changes to PrEP coverage and access recommendations, and monitor changing market dynamics. The range of PrEP products available and in the pipeline creates a tangible opportunity to substantially reduce transmission of HIV within the United States provided that policymakers and stakeholders take steps to highlight and solve the underlying disparities facing at-risk populations.

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Notes

1. HIV.gov, “Federal Response: About PACHA.”
2. Department of Health and Human Services, “National Strategic Plan: A Roadmap to End the Epidemic 2012–2025.”
3. US Preventive Services Task Force. “Prevention of Human Immunodeficiency Virus (HIV) Infection: Preexposure Prophylaxis.” June 2019.
4. Brooke E. Hoots, Teresa Finlayson, Lina Nerlander, and Gabriela Paz-Bailey, “Willingness to Take, Use of, and Indications for Pre-exposure Prophylaxis Among Men Who Have Sex with Men – 20 US Cities, 2014.” Clinical Infectious Diseases 63.5, 1 (September 2016): 672–77.
5. AIDSVu, “National Black HIV/AIDS Awareness Day 2020,” February 2020.
6. Kenneth H. Mayer et al., “Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review,” Advances in Therapy 37.5 (2020): 1778–1811.
7. Benedikt Pleuhs et al., “Health Care Provider Barriers to HIV Pre-Exposure Prophylaxis in the United States: A Systematic Review,” AIDS Patient Care and STDs 34,3 (2020): 111–123.
8. Patrick S. Sullivan et al., “Explaining racial disparities in HIV incidence in black and white men who have sex with men in Atlanta, GA: a prospective observational cohort study,” Annals of Epidemiology 25.6 (2015): 445–54.
9. Stephanie Shiau et al., “The Burden of COVID-19 in People Living with HIV: A Syndemic Perspective,” AIDS and Behavior 24.8 (2020): 2244–2249.
10. Congress.gov. “PrEP Access and Coverage Act,” June 2019.
11. HIV.gov. “Ready, Set, PrEP.”
12. Shira Stein, “Only 891 in Free HIV-Prevention Drug Program Meant for 200,000,” Bloomberg Law (June, 2020).