PreP Dispensing Barriers Linked to Higher HIV Incidence: US Claims Analysis

A comprehensive analysis of more than 2.6 million pharmacy claims reveals that individuals who never received their prescribed HIV pre-exposure prophylaxis (PrEP) experienced nearly double the rate of HIV-1 acquisition compared with those whose prescriptions were dispensed. The study, published in JAMA Network Open, highlights persistent access barriers despite federal mandates for insurance coverage.

Among 265,833 individuals tracked for at least 12 months, investigators reported a 3.7% HIV-1 incidence among those who had 50% or more of their PrEP claims rejected by payers, while those who abandoned more than half their claims had 2.8% incidence. In contrast, individuals with at least one dispensed claim had 2.0% incidence. Even among those who eventually received PrEP, delays of 1 to 7 days beyond same-day dispensing associated with 29% higher odds of HIV-1 acquisition (OR, 1.29; 95% CI, 1.13-1.47), according to senior author Kenneth H. Mayer, MD, medical research director and co-chair of the Fenway Institute and professor of medicine at Harvard Medical School, and colleauges.

Study Methods, Population

For the retrospective cohort study, Mayer et al used data from the IQVIA Longitudinal Access and Adjudication Data database, examining HIV-negative adults aged 18 years or older who initiated PrEP between January 2021 and December 2023. The analysis included all FDA-approved PrEP regimens: brand and generic emtricitabine/tenofovir disoproxil fumarate (F/TDF), emtricitabine/tenofovir alafenamide (F/TAF), and cabotegravir.

FDA-approved PrEP regimens: brand and generic emtricitabine/tenofovir disoproxil fumarate (F/TDF), emtricitabine/tenofovir alafenamide (F/TAF), and cabotegravir.

The study population of 399,902 individuals was predominantly male (87.2%), with 70.4% aged 18 to 39 years. Most lived in predominantly non-Hispanic White neighborhoods (59.6%), though 10.6% lived in Hispanic-dominant neighborhoods and 5.1% in non-Hispanic Black-dominant neighborhoods. Two-thirds (66.7%) had documented behaviors associated with HIV-1 acquisition, and 15.5% had sexually transmitted infections in their medical history.

Insurance Type is Critical

Generic F/TDF accounted for 52.2% of all claims and served as the reference point for comparison. Claims for other regimens showed substantially lower dispensing rates: brand F/TDF (OR, 0.36; 95% CI, 0.36-0.37), cabotegravir (OR, 0.52; 95% CI, 0.49-0.55), and F/TAF (OR, 0.93; 95% CI, 0.91-0.95).

Insurance type proved critical. Compared with commercial insurance, claims covered by Medicaid showed 61% lower odds of dispensing (OR, 0.39; 95% CI, 0.38-0.40), Medicare showed 40% lower odds (OR, 0.60; 95% CI, 0.57-0.63), and assistance programs showed 36% lower odds (OR, 0.64; 95% CI, 0.63-0.65). Individuals using Medicaid or Medicare in the rejected-claims group had HIV-1 incidence rates of 4.6% to 4.8%, compared with 3.2% to 4.0% in the dispensed group.

Out-of-pocket costs created additional barriers. As copayments increased, dispensing likelihood decreased. Claims with copayments of $50 or more had 93% lower odds of dispensing (OR, 0.07; 95% CI, 0.07-0.07) compared with zero-cost claims.

Geographic and demographic disparities emerged clearly. Claims in non-Hispanic Black-dominant neighborhoods had 5% lower odds of dispensing (OR, 0.95; 95% CI, 0.91-0.99), while those in Hispanic-dominant neighborhoods had 14% lower odds (OR, 0.86; 95% CI, 0.83-0.89) compared with non-Hispanic White-dominant neighborhoods.

Reasons for Claim Rejection

Among rejected claims, the most common barrier was formulary noncoverage (29.2% of rejections), followed by prior authorization requirements (14.7%), refill restrictions (12.8%), distribution limitations (9.9%), and plan limitations exceeded (9.1%).

Rejection patterns varied significantly by regimen. Formulary noncoverage affected 48.8% of brand F/TDF rejections and 59.4% of cabotegravir rejections, but only 25.2% of F/TAF rejections and 21.8% of generic F/TDF rejections. Prior authorization requirements were highest for F/TAF (21.7%) compared with other regimens (6.4%-13.2%).

HIV Incidence by Subgroup

Among individuals with sexually transmitted infections, HIV-1 incidence reached 6.2% in the rejected-claims group and 5.4% in the abandoned-claims group, compared with 3.1% in the dispensed group. For those living in Ending the HIV Epidemic jurisdictions, incidence in rejected and abandoned groups (3.9% and 3.1%) exceeded that in the dispensed group (2.1%).

Among the study’s limitations the researchers acknowledged the retrospective design and reliance on insurance claims data, which excluded medications obtained outside insurance coverage. Individual-level demographic data were limited, with neighborhood approximations used for race, ethnicity, and education. HIV-1 incidence relied on diagnostic and prescription codes rather than laboratory confirmation and the analysis could not capture event-driven or on-demand PrEP use patterns.

Authors' Closing Thoughts

The authors conclude that despite World Health Organization recommendations and federal mandates under the Affordable Care Act requiring coverage of PrEP without cost sharing since June 2020, priority populations continue facing substantial access barriers. "These results emphasize the need to enforce and defend current laws that lower payer barriers and highlight the potential consequences of these access restrictions," they wrote, concluding that "These findings can inform future strategies to enhance PrEP accessibility and adherence, ultimately contributing to a reduction in HIV-1 acquisition and the promotion of public health equity."

Editorial note: This research was funded by Gilead Sciences, Inc.