May 14, 2019
Mitchell Warren is the Executive Director of AVAC.
Gilead’s donation is an acknowledgment that there is a huge issue with PrEP access in America, as in many parts of the world. We welcome this indication that the company grasps the gravity of the situation. However, we urgently need a lower price for all. It’s disappointing that even this small step has taken so long.
At nine years post demonstrated safety and efficacy of oral PrEP and seven years post-FDA approval, Gilead is making this announcement quite late in the process of trying to scale PrEP to achieve public health impact. And it is nowhere near enough. The donation offers PrEP to only 200,000 individuals, while the CDC estimates that 1.1 million Americans overall are at substantial risk for HIV and should be offered PrEP. Based on what we know about the generic costs of Truvada (FTC/TDF), this donation offers a mere $10 million per year in drug supplies—irrespective of the list price for the drug.
It’s important to remember that PrEP is not a pill—it’s a program that has to include regular HIV and STD testing, support to take the pills as prescribed, training providers in culturally competent care, and strategic demand creation effort. The availability of more pills, while welcome, is not enough to move PrEP to the public health intervention that is needed for it to have a real impact for individuals and communities.
Gilead’s offer—and the announcement from Secretary of Health and Human Services Alex Azar—leave many open and important questions. How will the CDC distribute this additional oral PrEP? And how will they ensure it does not replace current PrEP access, but rather is additive? Who will pay for these distribution costs, as “free donations” often come with costs? Will Gilead continue its Truvada for PrEP Medication Assistance Program (MAP)? Will CDC and NIH—which, along with the Bill & Melinda Gates Foundation, funded the trials that demonstrated PrEP is safe and effective—still act on their intellectual property rights to Truvada for PrEP and reinvest any profits that could be realized into PrEP programs that work?
The bottom line is that the price of Truvada (FTC/TDF)—and Gilead’s new, additional PrEP pill, Descovy (FTC/TAF)—is still too high. We need sustainable price cuts, and clear strategic programs, that will support long-term access to and use of the medicines needed for PrEP. We cannot afford to lose any more time, or money, in translating PrEP’s promise into public health impact.