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A twice-yearly injection that protects against HIV is not a cost-effective use of NHS resources, the National Institute for Health and Care Excellence (NICE) has said.
In draft guidance, published on 9 September 2026, NICE acknowledged that lenacapavir (Gilead) reduces the risk of HIV more than no PrEP, or oral PrEP, and is likely to work as well as cabotegravir.
However, there were “uncertainties in the clinical evidence” considered by NICE’s evaluation committee, including how well the trial population reflects the UK population, as well as how many people who are at high risk of getting HIV and do not have PrEP would be expected to get HIV, it said.
The draft guidance also noted that there were uncertainties in the economic model used for the assessment, adding that “the cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources”. It added: “So, lenacapavir should not be used”.
However, a spokesperson for the Terrence Higgins Trust (THT), a charity that provides services relating to HIV and sexual health, said that progress towards the UK’s target of ending new HIV cases by 2030 could be at risk if the drug is not recommended.
Currently, pre-exposure prophylaxis (PrEP) to prevent HIV is available from NHS sexual health clinics as a daily oral pill containing tenofovir/disoproxil and emtricitabine.
If people cannot have oral PrEP — for instance, because of difficulty swallowing tablets, medical contraindication or social or personal circumstances — they can receive cabotegravir as an injection administered every two months. NICE recommended this treatment in November 2025.
“[The current options] aren’t working well for everyone due to a variety of reasons that include capacity in sexual health clinics, the taking of pills, fears about being seen with the pills or the requirement to get to a sexual health clinic frequently,” the spokesperson added.
Commenting on the decision, Nathan Burley, sexual health pharmacist and British Association for Sexual Health and HIV board member, said: “It’s clear from the draft NICE guidance that cost-effectiveness hasn’t been demonstrated. And that’s got two components to it: the cost that’s currently being proposed and the evidence and research to show the benefit. So… we need either lower cost or more evidence to sway that assessment for a favourable outcome so that sexual health clinicians can start using it in people that will benefit.
“Attending every eight weeks [as for cabotegravir] for any healthcare intervention is quite cumbersome on the patient journey […] The people that might benefit most [from twice-yearly lenacapavir] may have chaotic lifestyles, they might be in relationships where there’s controlling and coercive behaviour. They might be people with extremely busy lives or they’re peripatetic, they move around for work.”
In a press release published on 9 September 2026, Richard Angell, chief executive of the THT, suggested that lenacapavir might particularly benefit women and people who struggle with adherence, especially those in the military, people who are homeless or living in unstable housing, and people living in prison.
“The reality is that we need this innovation to end new HIV cases by 2030 and ensure nobody and no community is left behind. The numbers need to change and fast,” he added.
“As with access to oral PrEP a decade ago, it’s clear we have a fight on our hands to make sure it’s one of the tools in our arsenal for ending new HIV cases in the UK by 2030. Because time is ticking and that target will be missed unless we throw absolutely everything at it.”
Angell also urged NICE, NHS England and Gilead “to urgently get around the table and find a solution”.
“NICE need a better approach to preventative medicine and be transparent about what needs to happen for it to recommend lenacapavir as PrEP, Gilead needs to move on price, and NHS England needs to be ready to order higher volumes,” he continued.
A spokesperson for NICE commented: “The evidence shows that lenacapavir is effective at reducing the risk of HIV. However, the current price is too high for the benefits it provides beyond current treatments and therefore our committee cannot recommend its use.
“We had paused our process to allow discussions on a potential commercial access agreement to take place. As those discussions did not result in an agreement, we are now consulting on the draft guidance.”
A spokesperson for Gilead noted that the manufacturer recognised “this news will be disappointing for people who could benefit from additional HIV prevention options and for the wider HIV community working towards ending new HIV transmissions”.
“While this is not the outcome we had hoped for, the appraisal process remains ongoing, with a second appraisal committee meeting anticipated later [in 2026]. In the meantime, we will continue engaging with NHS England, the Department of Health and Social Care and other stakeholders to explore potential pathways that could support future access to lenacapavir for those who may benefit,” they added.
NHS England told The Pharmaceutical Journal that it could not comment on an ongoing commercial negotiation.
The NICE evaluation committee is due to reconvene on 3 November 2026 to review its decision, based on responses to its draft guidance.
Lenacapavir can be used to treat multi-drug resistant HIV in adults under an NHS England clinical commissioning policy published in July 2026.
