Although preexposure prophylaxis (PrEP) for HIV is effective, it is only effective if patients can access and afford it, according to a study and editorial recently published in Annals of Internal Medicine.
The Ending the HIV Epidemic initiative aims to reduce HIV infections by 50% in 5 years and 90% in 10 years. A foundational pillar in this initiative is protecting persons at risk for HIV with PrEP. Extensive evidence demonstrates PrEP with daily oral tenofovir disoproxil fumarate with emtricitabine (TDF-FTC) reduces the risk for HIV among at-risk persons. Only a fraction of persons who could benefit take it due to the cost of medication and other barriers patients face in getting PrEP coverage, especially for women, persons living in the South, and Black and Hispanic persons. In 2018, the average wholesale price of a 30-day supply of TDF-FTC was $2011. Patients typically have a much lower out-of-pocket (OOP) cost due to insurance companies, public insurance, or medication assistance programs. This retrospective cohort study estimated the OOP and third-part payments of PrEP TDF-FTC using a large pharmacy database.
The Centers for Disease Control and Prevention conducts PrEP surveillance using the IQVIA Real World Data Longitudinal Prescriptions database that estimates the number of persons prescribed PrEP annually. This database represents approximately 92% of all prescriptions dispensed from retail pharmacies and 60% to 86% of prescriptions dispensed from mail-order outlets in the United States. Prescriptions from closed healthcare systems and the Veterans Health Administration are not captured.
An algorithm was used to identify person-level use of TDF-FTC prescriptions among those aged at least 16 years, person-level use of other antiretroviral medications, use of TDF-FTC for 28 days or less, and medical claims with International Classification of Diseases, Clinical Modification, and codes for HIV or hepatitis B treatment. Prescriptions used for HIV treatment, HIV postexposure prophylaxis, or hepatitis B treatment were excluded. The OOP and third-party payments were recorded for each TDF-FTC prescription.
Results showed that third-party and OOP payments increased annually. Annual PrEP prescription prices increased from $73,739 in 2014 to $1,100,684 in 2018. Over that period, the average 30-day supply price for TDF-FTC increased from $1350 to $1638, a 5.0% compound annual growth rate. Of the $1638 in total payments per 30-day TDF-FTC tablets, OOP payments accounted for $94, increased from $54; and third-party payments accounted for $1544.
OOP payments per 30 tablets was lowest among Medicaid recipients ($3) when compared to those with Medicare ($80) or commercial insurance ($107). In the IQVIA database in 2018, payments for PrEP totaled $2.08 billion: $1.68 billion (80.7%) originated from prescriptions for persons with commercial insurance, $200 million (9.6%) for those with Medicaid, $48 million (2.3%) for those with Medicare, and $127 million (6.1%) for those with manufacturer insurance (Gilead Sciences). Since the IQVIA database does not capture every prescription, these are underestimations of national PrEP costs.
Other than direct medication payments, indirect costs of PrEP also hinder use. This includes the requirement of financial assistance and the ability to navigate various health insurance options. Since the PrEP costs have been escalating, this navigation has become an essential component of successful PrEP implementation and requires external resources. A possible solution to costs may be tenofovir alafenamide with emtricitabine (TAF-FTC) for PrEP, which was approved by the Food and Drug Administration in 2019. A cost-effectiveness analysis concluded TAF-FTC is not worth more than $370 per person per year over TDF-FTC. Additionally, other long-acting effective treatments in the pipeline may also eliminate the PrEP drug monopoly.
Overall, the study authors concluded that “[t]he high cost of PrEP does not diminish its central role in the Ending the HIV Epidemic initiative. Rather, it should promote action around ways to lower PrEP costs to the health care system to prevent coverage denials, eliminate prior authorization requirements, and increase access.”
- Furukawa NW, Zhu W, Huang YA, Shresha RK, and Hoover KW. National trends in drug payments for HIV preexposure prophylaxis in the United States, 2014 to 2018. Published online September 8, 2020. Ann Intern Med. doi: 10.7326/M20-0786
- Ard KL and Walensky RP. Editorial: payments for preexposure prophylaxis in the United States: too much for too few. Published online September 8, 2020. Ann Intern Med. doi: 10.7326/M20-5643