CVS Snubs Gilead’s HIV Shot as EU Grants Landmark Approval

CVS Health, the largest U.S. pharmacy-benefit manager, said it is not adding Gilead Sciences’ twice-yearly HIV prevention injection Yeztugo to its commercial or Affordable Care Act formularies, citing clinical, financial and regulatory factors. The decision, which comes less than two months after the drug’s June approval by the Food and Drug Administration, leaves most privately insured Americans without coverage for a medicine that carries a list price of more than $28,000 a year. Gilead shares fell on the coverage setback, highlighting investor concerns over near-term U.S. uptake. Federal programs such as the Veterans Administration and several state Medicaid plans have already agreed to reimburse Yeztugo, but broad commercial access remains uncertain. Five days after the CVS decision, the European Commission granted accelerated marketing authorisation for the same long-acting injection, branded Yeytuo, making it the first pre-exposure prophylaxis option administered just twice a year across the European Union, Norway, Iceland and Liechtenstein. The approval was backed by Phase 3 PURPOSE trials in which the regimen prevented HIV infection in 99.9% of participants. Gilead is now negotiating pricing and reimbursement with European health systems and has filed for regulatory review in markets including Australia, Brazil, Canada and South Africa. The diverging reactions from a major U.S. insurer and European regulators underscore both the clinical promise and the access challenges facing long-acting HIV prevention therapies.