– CVS Health excludes Gilead’s Yeztugo from commercial plans despite effectiveness.
– Yeztugo shown nearly 100% effective in preventing HIV in trials.
– U.S. government programs, including Medicare, cover Yeztugo.
CVS Health, the largest U.S. pharmacy benefit manager, has decided not to include Gilead Sciences’ new HIV prevention drug, Yeztugo, in its commercial plans for now. This decision comes despite the drug’s proven effectiveness, as it was shown to be nearly 100% effective at preventing HIV infection in large clinical trials. CVS cited clinical, financial, and regulatory factors as reasons for this exclusion. The company will also not cover Yeztugo under its Affordable Care Act (ACA) formularies, adhering to recommendations and mandates from the U.S. Department of Health and Human Services.
Yeztugo was approved in June for individuals at high risk of HIV, and it has generated optimism among Gilead, its investors, and AIDS activists about its potential to limit the spread of the virus. While CVS has opted out, several U.S. government healthcare programs, including the Veterans Administration and Medicare for those over 65, have already added Yeztugo to their coverage lists. Additionally, state-run Medicaid plans in California and New York are covering the drug.
The decision by CVS highlights the complexities involved in market access for new drugs, even those with high efficacy rates. The exclusion of Yeztugo from CVS’s plans may impact its market penetration and accessibility for patients relying on commercial insurance plans. However, its inclusion in government programs ensures some level of access for eligible patients.
In a related development, the U.S. Food and Drug Administration’s (FDA) recent rejection of a skin cancer therapy from Replimune Group has led to Krystal Biotech suspending a Phase 2 study of its similar drug, KB707. This decision reflects concerns over potential changes in the FDA’s approach to drug approvals, affecting Krystal’s development strategy.