CVS Delays Coverage of Gilead’s New HIV Prevention Shot

CVS Health, which operates the nation’s largest pharmacy benefit manager, has decided not to add Gilead Sciences’ newly approved HIV prevention injection, Yeztugo, to its commercial or Affordable Care Act formularies for the time being. A CVS spokesperson said the company weighed clinical, financial and regulatory considerations in reaching the decision. Yeztugo won US Food and Drug Administration clearance in June for people at high risk of HIV infection. The twice-yearly injection showed nearly 100% efficacy in late-stage trials and carries a list price of more than $28,000 a year. A source familiar with the matter said Gilead remains in negotiations with CVS over reimbursement terms. While CVS is holding back, several government programs—including Medicare, the Veterans Affairs health system and Medicaid plans in California and New York—have already started covering the drug. Rival pharmacy benefit managers are still reviewing the product; OptumRx expects to issue a decision in the coming weeks, and Express Scripts has not commented. Gilead said it is "extremely pleased" with ongoing discussions and expects Yeztugo to reach 75% insurer coverage by year-end and 90% by mid-2026. Investors were less sanguine: Gilead shares fell roughly 2.7% in pre-market trading after reports of CVS’s stance.