A Conversation With Alexa D’Angelo, Ph.D., M.P.H., Recent Doctoral Graduate from the CUNY School of Public Health and Health Policy

In 2019, the United States Preventive Services Task Force (USPSTF) gave certain types of pre-exposure prophylaxis (PrEP) a Grade A recommendation. This meant most insurers were required to cover it without cost-sharing. However, insurance denials and cost-sharing incidents have continued, specifically for sexual and gender minority people who have sex with men, according to a recent study published in Health Affairs.

The study, called ‘Insurance Denials And Cost Sharing For PrEP Among Sexual And Gender Minority People,’ surveyed 11,410 participants reporting current or former PrEP use and was managed by Alexa D’Angelo, Ph.D., M.P.H., a recent doctoral graduate from the CUNY School of Public Health and Health Policy.

D’Angelo’s study used data from the ongoing American Transformative HIV Study, which is examining the epidemic of methamphetamine use in sexual minority men. It is co-led by principal investigators Christian Grov, Ph.D., M.P.H., professor at the CUNY School of Public Health and Adam Carrico, Ph.D., professor at Florida International University.

D'Angelo recently sat down with Managed Healthcare Executive to discuss the details of the Health Affairs study and what they mean for the future of PrEP access.

Alexa D'Angelo, Ph.D., M.P.H.

MHE: How has PrEP changed the landscape of HIV prevention? What are the implications of someone being denied PrEP services?

D'Angelo: PrEP is the biggest biomedical innovation in HIV prevention in the last 15 years. Having PrEP as an option for folks is a game changer, not just in terms of having a biomedical HIV prevention strategy that is incredibly effective, but also for people's peace of mind and for their ability to engage in sex and not have the constant worry of HIV in the back of their mind.

Insurance-related barriers and cost-related barriers have enormous implications in people's lives.

If folks experience a denial from their insurer or experience prohibitive cost-sharing, that could be the difference between them remaining HIV negative or seroconverting to HIV positive.

I think it's also very anxiety-provoking for people to come across barriers. They’re engaging with the system in the way we as public health experts are encouraging them to do so, and then they’re coming across barriers.

MHE: The USPSTF designated PrEP as a Grade A prevention in 2019. What kind of insurance denials have been happening since?

D'Angelo: The USPSTF designation for PrEP was decided in 2019, but it didn't go into full effect until 2021.

In the paper that we just published, we surveyed over 11,000 current and former PrEP users, and we found that 23.7% reported experiencing a denial, ever.

When we looked closer, 69% of folks reported that their most recent denial for PrEP happened since 2021, so since the full implementation of the USPSTF requirements, which require most insurers to cover the cost of PrEP without cost sharing.

It’s important to point out that there's a denial range by PrEP drug.

For generic tenofovir disoproxil and emtricitabine (TDF/FTC), we found an 8.5% denial rate.

For Truvada, which is the brand name of generic PrEP, 33.4% of patients reported experiencing a denial.

For Descovy, which is a slightly different formula, we found that 48.2% of folks reported a denial.

MHE: Why have insurance denials continued?

D'Angelo: Brand-name, more costly versions of PrEP are being denied at higher rates because insurers use tiering practices where they prioritize the use of lower-cost drugs by instituting different coverage requirements, cost sharing and sometimes different utilization management practices like prior authorization and that's how they kind of nudge people to the more affordable drugs.

Depending on what insurers were doing, this wouldn't necessarily be at odds with the USPSTF requirement, which, at the time, only required that insurers cover TDF/FTC-formulated PrEP drugs like Truvada or the generic.

In terms of the law and the ACA, there's a very strong possibility that a lot of those denials that we're capturing in this study could be an efficient example of tiering.

We also did see that 8.5% of folks did experience a denial for generic TDF/FTC, which is lower, but it's still meaningful. I was expecting it to be really, really low.

In our paper, we suggest that there could be some tier misplacement where negotiations between drug manufacturers and pharmaceutical benefits managers result in generics being deprioritized because of an exchange in favorable rebates and tier placement. That's not an efficient use of tiering. Those would be slimy negotiations, but there is a possibility for that.

There are also plans that are not ACA compliant, like grandfathered plans that haven't changed since the implementation of the ACA, fixed indemnity plans, short-term duration plans or health sharing ministries.

MHE: A majority, 58%, of cost-sharing incidents were for laboratory blood work. Why is blood work required on PrEP?

D'Angelo: Bloodwork is included in the routine care that's associated with PrEP. It is for monitoring HIV and STIs and for Truvada patients to monitor kidney and liver functioning.

That's a big barrier for folks, because you need these test results to get your prescription and if you can't afford to do the blood work, or the cost sharing is prohibitive, then that's a huge challenge. I know some programs have provided free PrEP, but that can also undermine the program's success, because you need all of it—the counseling, clinical appointments, laboratory testing and the prescription. It all needs to be accessible and cost-free. That's really the ultimate goal for HIV prevention.

This is outside of our data collection period, but there was a billing code created in 2023 specifically for PrEP that accurately applies the USPSTF Grade A requirements, but we're not seeing that reflected yet.

MHE: Do you think the recent FDA approval of lenacapavir as a form of PrEP will play into future denials?

D'Angelo: This is the moment to be talking about what's about to happen with lenacapavir as a form of PrEP.

We already saw that, with Cabotegravir, the every-other-month injection that was priced at about $22,000 per year, insurers weren't paying for it.

When the USPSTF went to expand their designation, they included Descovy and Cabotegravir for injectable PrEP to ensure that folks would be able to access those options. Some people may be better at taking a pill every day, and some people may be better at getting an injection. So, you really want to have both of those accessible.

Now, with the approval of lenacapavir for injectable PrEP, it's even more incredible because it's every six months, which is significant in terms of innovation and HIV prevention.

Unfortunately, it was not included in the USPSTF expansion because it hadn’t been approved yet. It is priced at $28,000 a year, and so I am very concerned about coverage issues, and I anticipate major barriers there.

MHE: What policy interventions can be implemented to prevent these kinds of denials and cost-sharing incidents in the future?

D'Angelo: Expanding the USPSTF requirement to include lenacapavir as PrEP would be a great start.

You also want to make sure that that PrEP programing is accessible to folks who are uninsured. Unfortunately, a lot of the state-level programming may be undermined by some of the current defunding efforts under the Trump administration.

Reaching universal PrEP access is going to involve a real commitment to funding PrEP programming, both at the federal level and at the state level, by making sure that PrEP is available at STI clinics, LGBTQ health centers, through your private health insurance and through Medicaid plans in both expanded states and non-expanded states.

Right now, RFK Jr., as HHS Secretary, has been threatening to remove the panel of experts that make up the USPSTF. We're in a real state of uncertainty with the USPSTF, and that's very unfortunate, especially for moving forward with PrEP coverage requirements. I don’t want to put it all on insurers—we could also see better coverage if the price wasn't $28,000 a year. So, fighting that list price is very important too.