NICE Draft Recommends Against Routine NHS Funding For Gilead’s Twice-Yearly PrEP Yeytuo — Charities Warn Of Missed Opportunity

The National Institute for Health and Care Excellence (NICE) has issued a draft recommendation against routine NHS funding for Gilead’s twice-yearly pre-exposure prophylaxis (PrEP) drug lenacapavir, marketed for prevention as Yeytuo. The draft guidance has prompted strong criticism from several UK HIV charities, who say the decision could undermine efforts to reduce new HIV transmissions.

What NICE Said

An evaluation committee concluded that, for the population considered, the available evidence did not demonstrate that lenacapavir represents value for money. NICE highlighted uncertainties in the clinical data and in the economic modelling underpinning the submission. Specific concerns included whether trial populations reflect people at risk in the UK, assumptions about how many people not already on PrEP would acquire HIV, and measures used to capture HIV-related quality of life.

Regulatory Status And Context

The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the PrEP formulation of lenacapavir (Yeytuo) in December 2025. A different formulation, Sunlenca, is licensed in the UK since 2022 for the treatment of people living with HIV as part of combination antiretroviral therapy. International regulators have also approved the twice-yearly preventive formulation: the US Food and Drug Administration approved it under the brand name Yeztugo in June 2025, and the European Commission approved Yeytuo in August 2025.

Why Twice-Yearly PrEP Matters

Twice-yearly injectable PrEP represents an important potential alternative to daily oral regimens, which can be limited by adherence challenges. In clinical trials lenacapavir reduced the risk of HIV compared with oral PrEP; however, NICE said uncertainties about generalisability and long-term outcomes remain.

How Yeytuo Works

Lenacapavir is a long-acting capsid inhibitor that binds to the HIV‑1 capsid and interferes with critical stages of the viral lifecycle, reducing the virus's ability to replicate and spread after exposure. Regulators recommend using Yeytuo alongside established safer sex measures such as condom use.

Reactions From Charities

Richard Angell OBE, Chief Executive of the Terrence Higgins Trust, said: "We are profoundly disappointed by this initial decision by NICE. Twice-a-year injectable PrEP is the most exciting innovation in HIV prevention for years. PrEP is a gamechanger for HIV prevention and innovations like this must be jumped on and maximised — not kicked into the long grass and squandered."

Daniel Fluskey, Director of Policy at the National AIDS Trust, added: "We are deeply disappointed with the news today that a significant new HIV prevention drug will not yet be made available because of the failure to agree an affordable price. This is a real missed opportunity in the fight to end new HIV transmissions in England."

Data And Next Steps

In 2023 there were 6,402 new HIV diagnoses in the UK, and 107,949 people were receiving HIV care. The UK government has set a target to stop new HIV transmissions and end AIDS-related deaths by 2030. A further NICE committee meeting is scheduled for 3 November, leaving open the possibility of a revised recommendation if outstanding clinical or economic questions are resolved.

Bottom line: Yeytuo offers an innovative, twice-yearly PrEP option that could improve adherence and prevention outcomes, but NICE’s draft decision highlights gaps and uncertainties in evidence and cost-effectiveness that must be addressed before routine NHS funding is recommended.