After purging the Centers for Disease Control and Prevention’s vaccine advisory committee and replacing it with his own appointments, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is reportedly setting his sights on the U.S. Preventive Services Task Force (USPSTF) advisory panel, raising a red flag for HIV drugmakers.
The HHS secretary plans to dismiss all 16 existing members of the task force on the grounds that they are too “woke,” people familiar with the matter told The Wall Street Journal. While no official decision has been made yet, analysts are already highlighting the potential for a new, RFK Jr.-led USPSTF to specifically target HIV pre-exposure prophylaxis (PrEP) recommendations.
The USPSTF has made recommendations on coverage for preventive services and medication since 1984. Its 16 members are volunteer experts in prevention and evidence-based medicines who serve staggered four-year terms and have been vetted to ensure no conflicts of interest.
Gilead Sciences' newly launched twice-yearly PrEP Yeztugo does not currently hold a USPSTF recommendation since it was just approved in June, meaning its launch is “unlikely to be impacted in the short-term” by task force changes, Leerink analysts pointed out in a note to clients.
Still, if existing recommendations for the company’s Descovy and GSK’s Apretude were to be removed, patients could be steered toward cheaper generics. Furthermore, if the potential new USPSTF members don’t side with coverage for oral PrEPs, “they might not favor Yeztugo as well,” Jefferies analysts pointed out in their own note.
If the PrEP recommendation were to be removed, it doesn’t mean commercial insurance would stop covering the meds altogether, given the “economic value” of paying for the preventives versus HIV treatment, the Jefferies analysts noted. Nevertheless, all eyes will be on Gilead’s upcoming Yeztugo launch updates to determine if payers are already covering the drug absent a USPSTF recommendation, Leerink analysts wrote.
Gilead’s shares fell more than 2.5% on Monday morning with the USPSTF uncertainty. The company's PrEP products make up a large chunk of sales for its leading HIV business, with Descovy on its own bringing in more than $2 billion in 2024.
Earlier this month, RFK Jr.’s HHS office called off the task force’s scheduled July 10 meeting, which was meant to go over approaches to preventing cardiovascular disease. The postponed meeting caused concern from more than 100 healthcare organizations that together penned a letter (PDF) to key congressional leaders urging them to “protect the integrity” of the task force.
The turmoil came after the U.S. Supreme Court (SCOTUS) ruled that appointments for USPSTF members are made within the bounds of the U.S. Constitution, the result of a case that was heard after an employer argued that the committee’s recommendations were invalid because of the way its members were chosen. The employer was specifically challenging USPSTF’s recommendations for Affordable Care Act coverage of HIV PrEP resources.
At the time, analysts hailed the SCOTUS decision as a win for Gilead, declaring a potential headwind to the company’s PrEP portfolio “largely removed” and clearing the path forward for Yeztugo’s launch, BMO Capital Markets analyst Evan David Seigerman wrote in a note to clients at the time.
But the ruling did serve to confirm HHS’ appointment powers for USPSTF members, adding “uncertainty of RFK meddling in the task,” Leerink analysts added at the time.