As 2020 draws to a close, we asked David Alain Wohl, M.D., a professor of medicine in the Division of Infectious Diseases at the University of North Carolina and a highly respected HIV clinician-researcher, to take stock of the year's most momentous research developments and other critical events. In this exclusive series of articles, Wohl calls attention to 10 such developments that have tremendous short-term implications for our day-to-day efforts to improve HIV prevention, treatment, patient care, and policy in the U.S., and analyzes each development with his trademark wit and clinical savvy.
Before you get too excited by visions of injectable PrEP dancing in your head, the here-and-now reality is that we have oral PrEP. Which is super, since it works really well and is a value: Each case of HIV averted saves around $400,000 in lifetime costs.
The number of people taking PrEP in the U.S. has been growing, as has their diversity. However, while there will never be enough PrEP access to satisfy us all, and reports will continue to be issued about gaps in coverage and access, tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) has been available as PrEP for more than eight years—and we should be doing much better. Often-cited drags on expanded PrEP uptake include low provider knowledge and willingness to prescribe, stigma, under-appreciation of personal risk, and lack of access to clinics offering PrEP.
An important new analysis offers another barrier to PrEP, one that is almost sinister in its application predominantly in the U.S. South—which is home to more people living with HIV any other region of the U.S., and where the majority of new cases of HIV are diagnosed. That barrier is Prior Authorization (PA).
The dread PA is typically used as a mechanism by insurance companies to shift prescribers to a lower-cost alternative treatment or diagnostic. With a PA, providers or their staff are required to justify the more expensive selection to the insurer in order to get their approval before the order can be covered. In the case of PrEP, TDF/FTC was the lone option until tenofovir alafenamide (TAF)/FTC was approved—and yet, a PA was often required to document risk and eligibility for PrEP.
A team led by investigators from the University of Virginia-Charlottesville examined regional differences in the requirement of a PA for TDF/FTC by all qualified health plans offered in 2019 by the Affordable Care Act’s Health Insurance Marketplace. Overall, almost 17,000 qualified health plans were analyzed (18% in the Northeast, 20% in the West, 25% in the Midwest, and 37% in the South).
A PA for TDF/FTC was required by 19% of the plans. However, there were stark differences according to where the plan was located. __In the Northeast, 2% of plans required a PA for TDF/FTC PrEP, as did 6% in the West and 13% in the Midwest. In contrast, a PA was required for TDF/FTC PrEP by 37% of plans in the South. That means that plans in the South were 15 times more likely to require a PA than plans in the Northeast. Some southern states were exemplars of this discriminatorily practice, including Florida, Georgia, Mississippi, and Texas.
The Bottom Line on Prior Authorization for PrEP in the U.S.
If any part of the U.S. needs more PrEP, it is the South. To quote from the discussion section of the study:
“More than half of the African-American population in the United States live in the South. The CDC has estimated that the lifetime risk of acquiring HIV in the United States is 1:22 for African American men, 1:54 for African American women, and an astounding 1:2 for African American men who have sex with men. Moreover, the South has higher rates of stigma and bias associated with HIV and the lesbian, gay, bisexual, transgender, and queer or questioning communities as well as higher rates of HIV criminalization laws, which create additional barriers to PrEP uptake in the South.”
The practice of impeding PrEP use where it can be most beneficial is one of those impossible-to-fathom realities of living in the U.S., along with hours-long lines to vote, the criminalization of clean syringe programs, and decades of student loan debt.
Whether intended or not, the regional disparity in PrEP PA requirements is discriminatory by design and should be ended. Many state legislatures have the authority to regulate PAs—and some have used this power for good, like California’s approval for pharmacist-led PrEP. As if we in the South had need of another reason to vote in local and state elections, here is another.