Study Examines Regional Disparities in Prior Authorization Requirements for HIV PrEP

Researchers reveal that the proportion of qualified health plans that require prior authorization for HIV PrEP is highest in the South, suggesting this may be a barrier to access in the region arguably in most need of the drug.

In a paper published June 3 in JAMA Network Open, University of Virginia researchers looked at qualified health plans (QHPs) in the 2019 Affordable Care Act (ACA) Health Insurance Marketplace to see if there are any regional disparities in terms of prior authorization requirements for HIV pre-exposure prophylaxis (PrEP), a medication intended to prevent HIV.

The cross-sectional study included over 16,000 ACA-compliant individual and small-group market health plans in the United States and found that the proportion in the South that required prior authorization for HIV PrEP was 37%, compared with 13% in the Midwest, 6% in the West, and 2% in the Northeast. 

Compared with QHPs in the Northeast region, those in the South were nearly 16 times as likely to require prior authorization for PrEP. These higher rates are a possible barrier that contributes to decreased PrEP uptake in the South, according to the researchers, which is also the region with the most annual new HIV infections.

“HIV pre-exposure prophylaxis is really an essential tool to ending the HIV epidemic,” said lead author Kathleen A McManus, MD, MSCR, assistant professor of medicine at the University of Virginia in the Division of Infectious Diseases and International Health. “It is a pill that someone can take if they or their clinician identify that they might be at increased risk of getting HIV. And PrEP reduces the chances of getting HIV by more than 90% for sexual encounters and by more than 70% for injection drug use,” she told First Report Managed Care. 

There are significant economic implications. Avoiding just one new HIV transmission can wind up saving the health care system over $400,000 in lifetime costs, according to a 2013 study published in the Journal of Acquired Immune Deficiency Syndromes and conducted by researchers at CDC, Atlanta Veterans Affairs Medical Center, and Emory University. 

A number of barriers could be preventing uptake in the South, including stigma, lack of PrEP knowledge among doctors, people’s underestimation of their own personal HIV risk, the high cost of medication, and lack of health insurance. In previous studies, Dr McManus added, primary care and HIV clinicians have cited prior authorization requirements as one of the main barriers to prescribing PrEP, which is why she and her colleagues decided to explore this particular aspect and determine whether it, too, could be playing a role.  

The finding that QHPs in the southern region of the United States were more likely than QHPs in other areas of the country to require prior authorization is a disparity that could not be explained by other plan characteristics, according to Dr McManus. 

It is troubling considering this is the area that is arguably in most need of access to the drug. More than half of the US’ annual HIV diagnoses occur in the South. The policy is an example of structural racism, she said, noting that over half the country’s Black population lives in the South where they would be more likely to face this
barrier.

While it is not clear if prior authorizations impact PrEP prescription filling rates and delays in obtaining the medication, the researchers noted that one group demonstrated a delay in PrEP initiation for those who relied on drug manufacturer assistance programs, which require application paperwork similar to insurers’ prior authorizations.

Some states do have laws indicating that an insurance company is required to respond to prior authorization within 2 days, according to a 2018 American Medical Association Prior Authorization State Law Chart. Other states allow up to 10 days, however, and many states do not have any regulation regarding response time. 

Although some states have shorter time frames in place for drugs considered urgent, PrEP does not currently fall into that category. Perhaps it should, the researchers noted, as any delay in initiation for those at an increased risk can potentially result in new transmissions.

Future work in this realm of research should, among other things, explore whether and in what ways the availability of multiple formulations of PrEP impacts access and whether the use of pharmacy benefit managers affects prior authorization requirements, according to the study.

Considering there is limited regulation of prior authorization requirements for QHPs, the authors indicated that health policy laws at the state or federal level might be needed to remove this barrier. One example is the law passed in California last year, leading toward a new model of pharmacist-led PrEP access that requires all insurance companies to cover at least one therapeutically equivalent version of PrEP without prior authorization.

State regulators do review companies within their state to assess for outliers in the use of prior authorization, Dr McManus said, but this type of state oversight will miss regional level or state level outliers where PrEP access might be worse. 

Moving forward, she believes there should be an effort on the part of state insurance regulators or the Department of Health and Human Services Office of Civil Rights to take a closer look at why national insurance companies are putting added barriers in place for PrEP in the South and whether this constitutes discriminatory plan design.

Dr McManus and her coauthor disclosed financial support from Gilead Sciences, which manufactures PrEP medications Truvada and Descovy, and Dr McManus reported owning stock in Gilead Sciences. 

Reference:
McManus KA, Powers S, Killelea A, Tello-Trillo S, Rogawski McQuade E. Regional Disparities in Qualified Health Plans’ Prior Authorization Requirements for HIV Pre-exposure Prophylaxis in the United States. JAMA Netw Open. 2020;3(6):e207445. doi:10.1001/jamanetworkopen.2020.7445