Importance: HIV preexposure prophylaxis (PrEP) is a key component of the Ending the HIV Epidemic (EHE) Initiative to curb new HIV diagnoses. In October 2019, emtricitabine/tenofovir alafenamide was added as an approved formulation for PrEP in addition to emtricitabine/tenofovir disoproxil fumarate; despite availability of another formulation with a similar prevention indication, variations in coverage may limit access.
Objective: To assess qualified health plan (QHP) coverage, prior authorization (PA) requirements, and specialty tiering for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide following emtricitabine/tenofovir alafenamide approval as a PrEP treatment.
Design, setting, and participants: This cross-sectional study analyzed QHPs in the US that were compliant with the Patient Protection and Affordable Care Act from 2018 to 2020. QHPs were categorized by region and EHE priority jurisdictions. Data analysis occurred from March 2022 to March 2023.
Exposures: Enrollment in a qualified health plan certified by the Patient Protection and Affordable Care Act.
Main outcome and measures: Annual variation in QHP coverage and PA requirement for emtricitabine/tenofovir disoproxil fumarate and/or emtricitabine/tenofovir alafenamide. Descriptive statistics were reported for all outcomes. A secondary outcome was whether the PrEP formulation was determined by the QHP to be placed on a specialty drug tier.
Results: A total of 58 087 QHPs (19 533 for 2018; 17 007 for 2019; and 21 547 for 2020) were analyzed. QHPs covered emtricitabine/tenofovir disoproxil fumarate (19 165 QHPs [98.1%] in 2018; 16 970 QHPs [99.8%] in 2019; 20 045 QHPs [94.8%] in 2020) at a higher rate than emtricitabine/tenofovir alafenamide (17 391 QHPs [91.9%] in 2018; 15 757 QHPs [92.7%] in 2019; 18 836 QHPs [87.4%] in 2020). QHPs in the South required exclusive PA (ie, PA for 1 of the formulations even if the QHP covered both) for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide at the highest rates in all 3 years. In the South, the rate of PA for emtricitabine/tenofovir disoproxil fumarate increased from 806 of 8023 QHPs (10.0%) in 2018 to 3466 of 7401 QHPs (46.8%) in 2020. QHPs with exclusive PA requirement for emtricitabine/tenofovir disoproxil fumarate were higher in EHE jurisdictions than non-EHE jurisdictions (difference: 2018, 0.9 percentage points; 2019, 3.5 percentage points; 2020, 29.1 percentage points). QHPs were more likely to place emtricitabine/tenofovir disoproxil fumarate on a specialty tier compared with emtricitabine/tenofovir alafenamide (difference: 2018, 1.8 percentage points; 2019, 3.7 percentage points; 2020, 4.1 percentage points).
Conclusions and relevance: In this cross-sectional study, despite similar indications for biomedical prevention, QHPs were more likely to cover emtricitabine/tenofovir disoproxil fumarate than emtricitabine/tenofovir alafenamide, and QHPs were also more likely to subject emtricitabine/tenofovir disoproxil fumarate to PA or place it on a specialty tier despite the broader clinical indication. QHP PA requirements of emtricitabine/tenofovir disoproxil fumarate following emtricitabine/tenofovir alafenamide approval does not reflect clinical guidelines. The requirements could reflect differences in clinical indication, manufacturer discounts, or anticipation of a changing regulations and emerging generics. High rates of exclusive PA for emtricitabine/tenofovir disoproxil fumarate in areas where rates of HIV diagnoses are highest and PrEP is most needed (eg, the South and EHE priority jurisdictions) is concerning; policy solutions to address the growing PrEP health equity crisis could include regulator actions and a national PrEP program.