Gilead Sciences announced that its long‑acting HIV prevention drug, Yeztugo (lenacapavir), has been added to the commercial insurance plans of CVS Health, one of the country’s largest pharmacy benefit managers. The move removes a significant payer barrier and is expected to accelerate uptake of the twice‑yearly injectable in the U.S. market.
Yeztugo received FDA approval on June 18 2025 as the first and only twice‑yearly injectable for HIV pre‑exposure prophylaxis (PrEP). The drug’s high efficacy—over 99.9% of participants remaining HIV‑negative in pivotal trials—has positioned it as a compelling alternative to daily oral PrEP options such as Descovy and Biktarvy, as well as the recently approved GSK injectable Apretude.
Prior to this announcement, CVS had declined to cover Yeztugo, citing clinical, financial, and regulatory concerns, including the drug’s list price of more than $28,000 per year. The new formulary decision follows a period of negotiations in which Gilead and CVS reached an agreement on pricing and utilization management, allowing the drug to be listed without prior authorization or copay restrictions for commercial members.
The inclusion of Yeztugo on CVS’s formulary is a strategic win for Gilead’s HIV portfolio. By eliminating a major PBM barrier, the company can expand access to a patient population that may prefer a less frequent dosing schedule, potentially increasing market share against both oral PrEP and other injectable competitors. The decision also signals to other PBMs that Yeztugo’s pricing and clinical profile meet their coverage criteria, which could facilitate broader adoption across the industry.
Gilead’s Chairman and CEO Daniel O’Day emphasized the significance of the coverage change, stating that “adding Yeztugo to CVS’s commercial plans is a historic milestone that will help bring a life‑saving, convenient prevention option to more patients.” O’Day noted that the company has already reached its forecast of $150 million in sales for 2025 and expects Yeztugo to contribute substantially to that target as coverage expands.
The coverage decision is expected to reinforce Gilead’s leadership position in HIV prevention, strengthen its competitive moat against other PrEP modalities, and provide a new revenue stream that aligns with the company’s long‑term growth strategy in the HIV market.
Overall, the addition of Yeztugo to CVS Health’s commercial plans represents a critical step in expanding patient access to a novel, twice‑yearly HIV prevention therapy and underscores the importance of pharmacy benefit manager formulary decisions in shaping drug adoption.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.