CVS Excludes Gilead's HIV Drug from Coverage, Citing Cost Concerns

CVS Health, a leading US health insurer, will not cover Gilead's newly approved HIV drug Yeztego in its commercial healthcare plans for now, according to Reuters. The decision comes despite Yeztego's recent FDA approval and is based on the drug's high cost, which CVS believes may not be justified by its benefits.

CVS Health, a leading U.S. pharmacy benefit manager, has decided not to include Gilead Sciences' newly approved HIV prevention drug Yeztugo in its commercial healthcare plans for the time being. This decision was announced by the company despite the drug's recent FDA approval and proven effectiveness in clinical trials.

The decision by CVS Health is based on clinical, financial, and regulatory factors. The company cited the high cost of Yeztugo, which has a U.S. list price of more than $28,000 a year, as a primary concern. CVS Health believes that the benefits of the drug may not justify its high cost [1].

Yeztugo, a twice-yearly injection, was approved by the FDA in June and has shown nearly 100% effectiveness in preventing HIV infection in large trials. The drug is seen as a potential transformative tool in ending the HIV epidemic, which infects over 1.3 million people annually and has caused more than 42 million deaths worldwide [1].

The U.S. Preventive Services Task Force (USPSTF), which is supported by the U.S. Department of Health and Human Services (HHS), currently includes only three older drugs in its HIV prevention recommendations. Yeztugo's exclusion from these recommendations is another factor contributing to CVS Health's decision [1].

CVS Health's decision is a disappointment to AIDS activists and other stakeholders who see Yeztugo as a crucial step in combating the HIV epidemic. Gilead Sciences, however, remains optimistic about the drug's coverage prospects. The company is on track to secure 75% U.S. insurer coverage of Yeztugo by the end of 2025 and aims to achieve 90% coverage by June 2026 [1].

The decision by CVS Health highlights the complex interplay between drug pricing, clinical effectiveness, and regulatory guidelines in the U.S. healthcare system. It also underscores the ongoing debate about the sustainability of high drug prices and the role of pharmacy benefit managers in negotiating drug coverage.

References:

[1] https://www.investing.com/news/stock-market-news/exclusivecvs-holds-off-adding-gileads-new-hiv-prevention-shot-to-drug-coverage-lists-4203160