Terrence Higgins Trust has said it is “profoundly disappointed” after the National Institute for Health and Care Excellence (NICE) recommended against approving lenacapavir, a twice-yearly injectable form of HIV prevention medication, for use on the NHS.
The HIV charity warned that the decision could hamper efforts to end new HIV transmissions by 2030 and widen existing inequalities in access to HIV prevention.
Lenacapavir is a long-acting form of pre-exposure prophylaxis (PrEP), a medication that prevents HIV acquisition. Unlike existing PrEP options, which are taken as tablets or, for some people, as a two-monthly injection, lenacapavir only requires administration twice a year.
Terrence Higgins Trust argues the injectable treatment could prove transformative for people who struggle to take daily medication, face barriers to attending sexual health clinics regularly, or have concerns about being seen carrying PrEP tablets.
NICE announced on Wednesday (9 September) that it was not recommending lenacapavir for NHS use as PrEP at this stage. The decision will be reviewed on 3 November.
Responding to the announcement, Terrence Higgins Trust chief executive Richard Angell OBE described the ruling as a major setback for HIV prevention. "We are profoundly disappointed by this initial decision by NICE," he said.
"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.
"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."
Angell compared the current situation to the lengthy battle to secure access to oral PrEP a decade ago, warning that delays could undermine the government's ambition of ending new HIV cases in the UK by 2030.
"Time is ticking and that target will be missed unless we throw absolutely everything at it," he said.
The charity is now calling on NICE, NHS England and manufacturer Gilead Sciences to work together to secure access to the treatment.
Angell urged all parties to "get around the table and find a solution", adding that NICE should provide greater clarity on what would be required for approval, while Gilead should review pricing and NHS England prepare for wider uptake.
Terrence Higgins Trust believes injectable PrEP could play a particularly important role in reaching communities that are currently underserved by existing HIV prevention programmes.
While oral PrEP has been highly effective and widely adopted among many gay and bisexual men, the charity said lenacapavir could help expand access among women and others who may find current prevention options less practical.
Angell said the treatment would increase choice for people unable to take PrEP in tablet form and could be especially beneficial for those who struggle with adherence, including members of the armed forces, people experiencing homelessness or unstable housing, and those in prison.
"The injectable is an important way of increasing choice," he said. "It will also benefit those who struggle with adherence.
"NICE has assessed the current numbers for lenacapavir provision and said no based on its criteria. But 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 charity has pledged to continue campaigning for access to the treatment ahead of NICE's review in November, arguing that long-acting injectable PrEP could become a key tool in the UK's efforts to eliminate new HIV transmissions.
Scene was founded in Brighton in 1993, at a time when news stories about Pride protests were considered radical.
Since then, Scene has remained proudly independent, building a platform for queer voices. Every subscription helps us to report on the stories that matter to LGBTQ+ people across the UK and beyond.
Your support funds our journalists and contributes to Pride Community Foundation’s grant-making and policy work.
Member discussion