NICE rejects twice-yearly HIV PrEP injection for NHS use
NICE said its cost-effectiveness was above the range considered an acceptable use of NHS resources
By Callum Wells
A twice-yearly HIV prevention injection has not been recommended for routine NHS use in England by NICE.
The draft guidance covers lenacapavir, sold by Gilead under the brand name Yeytuo, which is given every six months to prevent sexually transmitted HIV-1 infection.
NICE said its cost-effectiveness was above the range considered an acceptable use of NHS resources. It also raised “uncertainties in the clinical evidence” and the economic modelling used in its assessment.
“Lenacapavir could offer protection against HIV for six months from a single injection” – Dr Cara Saxon, president of BASHH
The recommendation is not final. NICE is consulting on the draft guidance and will reconsider its position on 3 November.
Lenacapavir was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2025 for adults and adolescents. Treatment involves an injection every six months, alongside tablets when treatment is started.
Daily oral PrEP remains the main prevention option available through NHS sexual health services. Cabotegravir, sold by GSK as Apretude, is another injectable option and is administered every two months for eligible people who cannot reliably take daily tablets.
Dr Cara Saxon, president of the British Association for Sexual Health and HIV (BASHH), said: “Every day, sexual health and HIV professionals support people who face significant barriers to accessing and using existing HIV prevention options. Lenacapavir could offer protection against HIV for six months from a single injection.
Richard Angell OBE, chief executive of the Terrence Higgins Trust, said he was “profoundly disappointed”
“This has the potential to be transformative for some people for whom current available options, such as daily oral PrEP, just simply aren’t viable,” she added. “It could also enable us to reach people who are facing huge inequity and barriers to access, including women and people from marginalised communities.”
Richard Angell OBE, chief executive of the Terrence Higgins Trust, said he was “profoundly disappointed” by NICE’s initial stance on Yeytuo.
“Twice-a-year injectable PrEP is the most exciting innovation in HIV prevention for years. But history is repeating itself when it comes to PrEP access in England and Wales – clearly, lessons haven’t been learned,” he added.
Angell called for Gilead to offer a lower price and NHS England to order higher volumes.
“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. PrEP is a game-changer for HIV prevention, and innovations like this must be jumped on and maximised – not kicked into the long grass and squandered.”