GILD · News · 20260910N

HIV PrEP Regulatory Expansion

GILEAD SCIENCES, INC. · 2026-09-10 · Importance 47 · Surprise 60

The UK's National Institute for Health and Care Excellence (NICE) issued draft guidance recommending against routine NHS coverage in England for Gilead's twice-yearly injectable lenacapavir (Yeztugo) for HIV pre-exposure prophylaxis. NICE cited cost-effectiveness concerns, uncertainties in the clinical evidence, and questions about the economic model relative to existing PrEP options. The appraisal remains ongoing, with a follow-up meeting scheduled for November 3, 2026; HIV charities urged Gilead to reduce pricing and NHS England to prepare for higher prevention volumes.

Key facts

• NICE's appraisal process for Gilead's twice-a-year PrEP med includes a follow-up meeting scheduled for November 3rd. source
• NICE issued initial draft guidance recommending that Gilead's twice-yearly injectable lenacapavir (Yeytuo/Yeztugo) for HIV PrEP will not be routinely funded by the NHS due to cost-effectiveness concerns and uncertainties in clinical evidence. source
• Fierce Pharma reported that NICE's draft guidance recommended against national coverage of Gilead Sciences’ twice-a-year HIV prevention medication, lenacapavir (Yeztugo), on the NHS in England. source