CVS Refuses to Cover Gilead's HIV Prevention Drug

CVS Health will not add Gilead's HIV prevention drug Yeztugo to its commercial plans or ACA formularies. The decision is based on clinical, financial, and regulatory factors, according to a spokesperson. The medication is proven effective, but CVS follows recommendations and mandates from the US Department of Health and Human Services for its ACA preventive program.

In a significant development for HIV prevention, CVS Health (NYSE:CVS) has decided not to include Gilead Sciences' (NASDAQ:GILD) new HIV prevention drug Yeztugo in its commercial plans or Affordable Care Act (ACA) formularies. This decision, announced on July 2, 2025, is based on clinical, financial, and regulatory considerations [1][2][3].

Yeztugo, a twice-yearly injection, has shown nearly 100% effectiveness in preventing HIV infection in large trials. However, its high annual list price of over $28,000 has been a significant factor in CVS's decision. The company's spokesperson, David Whitrap, cited clinical, financial, and regulatory factors, stating that the ACA preventive program follows recommendations and mandates from the U.S. Department of Health and Human Services (HHS) [1][2][3].

The current HIV prevention guidelines from the U.S. Preventive Services Task Force (USPSTF), supported by HHS, include only three older drugs: generic Truvada, Gilead's Descovy, and ViiV Healthcare's Apretude. Despite Yeztugo's proven effectiveness, it does not meet the current recommendations [1][2][3].

AIDS advocates have criticized CVS's decision, viewing it as a missed opportunity given Yeztugo's potential to transform HIV prevention. Mitchell Warren, executive director of AVAC, called the decision a "grave disappointment" and highlighted the unsustainable drug pricing in the U.S. [1][2].

Gilead is still in negotiations with CVS regarding Yeztugo coverage, and the company expects 75% of U.S. insurers to cover the drug by the end of 2025 and 90% by mid-2026. U.S. government programs, including the Veterans Administration and Medicare, have already added Yeztugo to their coverage lists, along with several state Medicaid plans such as California and New York [1][2][3].

In a separate development, a federal judge ordered CVS Health's Caremark unit to pay nearly $290 million in a Medicare fraud case, further adding to the company's challenges [2].

References:
[1] https://www.investing.com/news/stock-market-news/cvs-health-wont-cover-gileads-new-hiv-prevention-drug-yeztugo--reuters-93CH-4203165
[2] https://stocktwits.com/news-articles/markets/equity/cvs-health-reportedly-keeps-gilead-s-new-hiv-preventative-shot-off-its-plans-faces-290-m-medicare-fraud-ruling/chsShxPRdLd
[3] https://www.reuters.com/business/healthcare-pharmaceuticals/cvs-holds-off-adding-gileads-new-hiv-prevention-shot-drug-coverage-lists-2025-08-20/