CVS Health, the operator of the nation’s largest pharmacy benefit manager, has decided not to include Gilead Sciences’ new HIV prevention injection, Yeztugo, on its commercial drug coverage lists for now, despite the treatment’s strong clinical results.
The decision was guided by “clinical, financial, and regulatory considerations,” CVS spokesperson David Whitrap confirmed in an email to Reuters. The company also excluded Yeztugo from Affordable Care Act (ACA) plans, citing federal guidelines.
Current recommendations from the U.S. Preventive Services Task Force (USPSTF), backed by the Department of Health and Human Services (HHS), only endorse three older HIV prevention drugs.
Yeztugo, approved in June, is a twice-yearly injectable with a U.S. list price of more than $28,000 annually. While negotiations between CVS and Gilead are reportedly ongoing, the exclusion drew sharp criticism from HIV advocates.
“This decision is a grave disappointment and a missed opportunity,” said Mitchell Warren, executive director of AVAC, a global AIDS advocacy group. “The drug’s price reflects a broader problem with an unsustainable U.S. pharmaceutical system.”
Gilead maintains it is making progress in payer discussions, stating that most insurers cover HIV prevention products without cost-sharing barriers. The company expects Yeztugo to secure coverage from 75% of U.S. insurers by the end of 2025, rising to 90% by mid-2026.
Pharmacy benefit managers (PBMs) — including CVS Caremark, UnitedHealth’s OptumRx, and Cigna’s Express Scripts — oversee nearly 70% of U.S. specialty drug prescriptions. Optum said it will review Yeztugo for coverage soon, while Express Scripts has yet to comment.
Meanwhile, federal health programs such as Medicare, the Veterans Administration, and several state Medicaid plans — including California and New York — have already added Yeztugo to their formularies.
Backed by large-scale clinical trials showing near-100% effectiveness in preventing HIV, Yeztugo has been hailed as a potential breakthrough in the decades-long fight against the virus, which continues to infect 1.3 million people annually worldwide. The World Health Organization estimates that more than 42 million people have died from AIDS-related illnesses since the epidemic began over 40 years ago.
Still, questions remain about the drug’s accessibility and long-term affordability. Analysts warn that a recent Supreme Court ruling affirming HHS authority over the USPSTF could reshape prevention drug coverage, particularly as agency leadership faces political uncertainty.
The USPSTF currently recommends daily oral PrEP options such as Truvada (now available as a generic), Gilead’s Descovy, and ViiV Healthcare’s bimonthly injectable Apretude. Gilead executives, including CEO Daniel O’Day, argue that preventive drugs like Yeztugo are cost-effective compared with the estimated $1 million lifetime cost of treating an HIV patient.
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