CVS Won’t Add Gilead’s Yeztugo to Commercial Plans; FDA Rejection Spurs Krystal Trial Pause
CVS declines coverage for Gilead’s highly effective HIV prevention drug Yeztugo for now; an FDA rejection of a separate skin‑cancer therapy prompts Krystal to halt KB707 enrollment.
CVS Health said it will not add Gilead Sciences’ newly approved HIV prevention drug Yeztugo to its commercial plans for now, citing clinical, financial, and regulatory factors. The company also will not cover Yeztugo under its Affordable Care Act formularies because its ACA preventive program follows U.S. Department of Health and Human Services recommendations and mandates. Yeztugo, approved in June for people at high risk of HIV, demonstrated nearly 100% effectiveness in large trials; U.S. government programs including the Veterans Administration and Medicare have already added the drug, and several state Medicaid plans such as California and New York are covering it. Separately, the U.S. Food and Drug Administration’s rejection of a Replimune skin‑cancer therapy led Krystal Biotech to suspend enrollment in a Phase 2 study of its KB707 candidate, citing “heightened uncertainty regarding potential accelerated approval pathways.” Krystal noted KB707 was in early development and not central to its valuation, but the move highlights how FDA decisions can produce downstream repercussions for other companies. The article is marked as a STAT+ exclusive.
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