The National Institute for Health and Care Excellence (NICE) has recommended against reimbursement for Gilead’s twice-a-year PrEP medication lenacapavir, prompting a rebuttal from several HIV charities in the UK.
An evaluation committee at the watchdog said that the drug should not be used as a PrEP option alongside safer sex practices to reduce the risk of HIV in adults and young people at high risk of the virus.
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The draft recommendation, which is not yet final, means lenacapavir would not be required to be funded and should not be used routinely in the NHS in England.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the PrEP formulation of lenacapavir in December 2025. A formulation of lenacapavir was already approved in the UK under the brand name Sunlenca in 2022, which is for the treatment of HIV infection in combination with other antiretrovirals. The newer formulation, sold under the brand name Yeytuo, allows for an injection once every six months.
Yeytuo’s approvals in 2025 have been hailed as a momentous step for HIV prevention. Currently, most PrEP therapies require daily oral administration, which often leads to poor adherence.
However, NICE’s committee said that “available evidence does not suggest that lenacapavir is value for money in this population.”
In its recommendation, NICE pointed to the breadth of PrEP options that include GSK’s Apretude (cabotegravir). While the agency said that lenacapavir reduces the risk of HIV more than oral counterparts, it pointed to uncertainties in clinical evidence. This includes how well the trial population reflects the UK population, and how many people who are at high risk of getting HIV and do not have PrEP would be expected to get HIV.
NICE also raised questions with economic modelling that include how many patients favour PrEP and measures on HIV-impacted quality of life.
Charities “profoundly disappointed”
There still might be a twist ahead. A second evaluation committee meeting is scheduled for 3 November. In the meantime, HIV charities are already declaring where they stand on the matter.
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, commented: 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.”
There were 6,402 new diagnoses of HIV in the UK in 2023, with 107,949 people receiving HIV care that year. The UK Government aims to stop new HIV transmissions and end AIDS-related deaths by 2030.
Fluskey continued: “This is a real missed opportunity in the fight to end new HIV transmissions in England. The potential significance of lenacapavir is not in doubt… We believe it would save lives, reduce health inequalities, and go towards achieving the UK Government’s goal of ending new HIV transmissions by 2030.”
Yeytuo works by reducing the risk of the HIV-1 virus multiplying and spreading throughout the body if a person is exposed to the virus. The drug binds to the HIV-1 virus’s outer layer, interfering with multiple steps in the viral lifecycle. The MHRA recommends Yeytuo’s use alongside safer sex practices, such as condoms.
In June 2025, the US Food and Drug Administration (FDA) approved the twice-yearly treatment under the brand name Yeztugo, while the European Commission (EC) approved Yeytuo in August of the same year.
