Researchers report higher PrEP use and fewer insurance-related issues from 2019 to 2021, but the Braidwood versus Becerra case could impact these improvements.

“Despite increases in insurance coverage, changes in regulations for PrEP coverage, and more programs providing PrEP for free, many people still struggle to pay for PrEP,” Alexa D’Angelo, MPH, PhD-candidate, notes. “It is also important to understand that PrEP is sophisticated medical care. One needs a medical provider they can see several times a year and a pharmacy that can dispense PrEP. Lab work is involved at every medical visit, and patients must be vigilant about seeing their provider, renewing prescriptions on time, and taking PrEP as prescribed.”

Further, despite being designated a Grade A prevention service by the USPSTF in 2019, certain patients were still subject to prohibitive out-of-pocket costs, such as those on ACA non-compliant plans, according to D’Angelo. “Today, the picture is more complex, with the authority of the USPSTF currently being decided in court following the Braidwood Management Inc. versus Becerra ruling. The future of PrEP coverage hinges on the verdict of the appeal on this decision.”

For a study published in JAIDS, D’Angelo and colleagues examined data from Together 5,000, a longitudinal cohort study led by Principal Investigator Dr. Christian Grov from the CUNY Institute for Implementation Science in Population Health. The cohort includes gay, bisexual, and other men who have sex with men who are vulnerable to HIV infection. The researchers examined challenges related to cost and insurance that undermined PrEP use among PrEP users in the Together 5,000 cohort over the course of 3 years.

PrEP Use Increases From 2019 to 2021

The researchers observed an increase in PrEP use over time. In 2019, 16.5% of participants reported being on PrEP; in 2020, that number increased to 995 (21% of the 2020 sample), and by 2021, 1,133 participants were currently using PrEP, accounting for 24.5% of the yearly sample.

In 2019, more than half of those who reported current PrEP use were White (52.8%); 23.4% were Latinx and 10.9% were Black. Almost all participants (96.7%) identified as a cisgender man and most (89.5%) reported their sexual orientation as gay. Most participants also had health insurance (90.1%).

Improvements were seen for most issues related to payment and insurance between 2019 and 2021, according to D’Angelo (Table). However, she also notes that those who reported using PrEP in the past year who were not currently on PrEP were more likely to report experiencing payment/insurance challenges regarding PrEP. “This may suggest that those who are encountering these barriers are more likely to discontinue PrEP, which is a threat to individual-level protection from HIV and population-level HIV prevention goals.”

Continuing Coverage Depends on Braidwood Vs Becerra

Clinicians are “no strangers” to insurance issues, D’Angelo notes. “No one deals more directly and consistently with insurance providers than physician offices,” she says. “I suspect many of them are aware of the challenges that can arise when billing for PrEP, including denials and prior authorization issues.”

The study results showed no improvements in insurance denials of PrEP, which is a finding she encourages clinicians to keep in mind. “This might seem counterintuitive with the passage of the USPSTF grade A coverage requirements going into effect during this period,” D’Angelo explains. “However, there are other PrEP drugs on the market that were not included in that 2019 regulatory mandate. While providers should be aware of the potential for coverage issues with the newer drugs, the good news is that the USPSTF recently added these newer forms of PrEP to their recommendation list, which should mean more reliable coverage for these drugs in the coming years, depending on the outcome of the Braidwood versus Becerra appeal.”

In the context of the appeal, she encourages researchers to remain attentive in tracking emerging issues regarding insurance coverage of PrEP.

“Right now, most private insurance providers must continue to cover PrEP without cost-sharing, which is fantastic,” D’Angelo says. “However, I worry about noncompliance during this time. Researchers need to gather high-quality data from folks using PrEP to measure their experiences paying for PrEP in the coming months and years and stay up to date with the latest information from a legal perspective. One way I’ve been able to do the latter is by attending meetings organized by PrEP4All, an advocacy group that has been closely following the Braidwood case. Their meetings are attended by legal professionals, advocates, HIV care providers, and community members, and are an amazing source of information. Should the appeal not turn out the way we hope, we could have a whole new set of coverage challenges to contend with, but I am optimistic.”