Gilead's New HIV Prevention Drug Yeztugo Excluded from CVS Health Plans

CVS Health has declined to add Gilead's new HIV prevention drug Yeztugo to its commercial plans and Affordable Care Act formularies, citing clinical, financial, and regulatory factors. The decision has sparked criticism from HIV advocates, who point to the unsustainable U.S. drug pricing. Gilead, however, remains confident in the drug's adoption, projecting 75% U.S. insurer coverage by 2025.

Title: CVS Health Declines Coverage of Gilead's New HIV Prevention Drug Yeztugo

CVS Health, the parent company of the United States' largest pharmacy benefit manager (PBM) CVS Caremark, has decided not to cover Gilead Sciences’ long-acting HIV prevention drug Yeztugo in its commercial plans or Affordable Care Act (ACA) formularies. The decision was announced following a careful review of clinical, financial, and regulatory considerations by the company's external Pharmacy and Therapeutics (P&T) Committee of independent medical experts [1].

Yeztugo, which utilizes Gilead’s proven HIV-1 capsid inhibitor lenacapavir, received FDA approval in June. The drug is designed to be a twice-yearly injection, providing a more convenient alternative to daily pills. Despite its potential benefits, CVS Health has not yet added Yeztugo to its commercial template formularies or its ACA formularies. The U.S. Preventive Services Taskforce (USPSTF) has also not recommended Yeztugo as a PrEP therapy [1].

The cost of Yeztugo before discounts and rebates is approximately $28,000 annually, which is significantly higher than the current PrEP options. CVS Health's spokesperson stated that the company supports the USPSTF guidelines and believes in providing easy access to PrEP medications for people living in the U.S. However, the company believes that it is inappropriate for branded pharmaceutical manufacturers to try to manipulate pre-existing guidelines with clinically similar products that are priced far higher than what is already on the market [1].

Despite the coverage rebuff, Gilead may still be negotiating with CVS on Yeztugo. Gilead's spokesperson expressed confidence in the drug's adoption, projecting 75% U.S. insurer coverage by the end of 2025 and 90% coverage by mid-2026. The company noted that most insurers continue to cover HIV prevention products without cost barriers [1].

The decision by CVS Health comes amid heightened scrutiny over the company's business practices. Recently, a federal judge ordered CVS’ Caremark unit to pay nearly $290 million in damages and penalties for overcharging Medicare. CVS is appealing the judgment [2].

References:
1. [1] https://www.fiercepharma.com/pharma/now-cvs-declines-cover-gileads-twice-yearly-hiv-prep-treatment-yeztugo
2. [2] https://www.inkl.com/news/cvs-health-declines-to-add-gilead-s-steeply-priced-new-hiv-prevention-drug-to-its-plans