On June 18, 2025, the FDA approved Gilead’s Yeztugo (lenacapavir) for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1). Yeztugo is the first FDA-approved, twice-yearly, subcutaneous PrEP option for HIV prevention. Gilead has announced that the list price for Yeztugo will be $28,218 annually.
The U.S. Preventive Services Task Force (USPSTF) has not yet provided a formal recommendation specific to Yeztugo related to coverage under the Affordable Care Act (ACA). However, USPSTF does list their recommendations for PrEP as an “A” grade, which means the Task Force strongly recommends the specific preventive service be covered by insurers and employers. Step therapy restrictions are not permitted for PrEP products under most commercial insurance plans, consistent with Affordable Care Act (ACA) mandates and recommendations from the U.S. Preventive Services Task Force (USPSTF).
