Compared with Affordable Care Act (ACA) marketplace health plans in the Northeast, those in the South are a staggering 16 times more likely to require preauthorization of prescriptions for pre-exposure prophylaxis (PrEP), according to a recent study published in JAMA Network Open.


The widespread prevalence of this added bureaucratic hurdle among Southern private insurance plans available through the ACA (aka Obamacare) may help explain why the region has seen a lower rate of PrEP uptake than other parts of the country. Lower use of PrEP is particularly concerning in the South because that is where the epidemic is the most severe.


Many PrEP prescriptions, however, are covered by sources other than ACA plans, including private plans provided by employers, as well as Medicaid and Medicare. Free PrEP is available for uninsured individuals thanks to a donation by Gilead Sciences to the federal initiative to combat HIV. Gilead manufactures Truvada (tenofovir disoproxil fumarate/emtricitabine) and Descovy (tenofovir alafenamide/emtricitabine). Truvada was approved as PrEP in 2012, while Descovy was approved in 2019.


Kathleen McManus, MD, MSc, an assistant professor of medicine and infectious diseases at the University of Virginia, and her colleagues studied qualified health plans (QHPs) available through the ACA marketplace. They included all plans that comply with the ACA, including those for individuals and small groups.

All told, the study included 16,853 health plans; 18% were from the Northeast, 20% were from the West, 25% were from the Midwest and 37% were from the South.

A total of 18.9% of the health plans required prior authorization for Truvada as PrEP. This rate was 2.3% in the Northeast, 6.2% in the West, 13.3% in the Midwest and 37.3% in the South.

This meant that compared with health plans in the Northeast, those in the South were 15.9 times more likely to require prior authorization for Truvada as PrEP. Plans in the Midwest and West were a respective 5.7-fold and 2.7-fold more likely to require authorization than those in the Northeast.


“We tried to see if we could explain the use of prior authorization by looking at other plan characteristics to see if a plan uses prior authorization in certain settings,” McManus said in a press release. “But we could not explain why more health care plans in the South require it. We would think that where there is more HIV you would actually want to see more HIV prevention medication to try to stop and turn things around; that is why we are so concerned to find this.” 


Given the fact that the U.S. Preventive Services Task Force gave Truvada as PrEP an “A” rating last year, federal law will require all health plans to cover this form of PrEP starting in 2021. The plans must do so with no cost sharing—meaning no co-pay, co-insurance or deductible requirements to pay for the cost of Truvada. Meanwhile, a generic version of Truvada is expected to emerge in the coming days. This is expected to launch an era in which the drug’s list price is brought down substantially, especially after another six months have passed and multiple companies are allowed to produce generic Truvada.


“Advocates have worried that the new preventive coverage requirement of PrEP may lead to insurers trying to limit access by using arbitrary, nonclinically based prior authorization requirements,” the study authors wrote. “Unfortunately, our research demonstrates that prior authorization is already being used by almost 20% of QHPs and that it is being used more often in the South.”


To read the study, click here.

To read a press release about the study, click here.