NICE says no to Gilead's lenacapavir for HIV PrEP

Gilead's twice-yearly injectable for pre-exposure prophylaxis (PrEP) of HIV, lenacapavir, will not be routinely funded by the NHS, according to initial draft guidance from reimbursement authority NICE.

NICE said that the cost-effectiveness figures for lenacapavir are above the range that would be considered an acceptable use of NHS resources, also pointing to "uncertainties in the clinical evidence" for the medicine.

The decision – which is not finalised and could change as it is subject to a consultation period – has been slammed by HIV charities including the British Association for Sexual Health and HIV (BASHH) and the Terence Higgins Trust, which said it undermines the UK government's target of ending new HIV cases by 2030.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved the twice-yearly injectable formulation of capsid inhibitor lenacapavir for PrEP last December, under the Yeytuo brand name, for the prevention of sexually transmitted HIV-1 infection in adults and adolescents. NICE is due to review its reimbursement decision on 3rd November.

"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," commented Dr Cara Saxon, president of BASHH.

"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."

In the UK, the standard first-line choice for PrEP is daily pills containing emtricitabine and either tenofovir disoproxil or tenofovir alafenamide – the former available as a generic and the latter sold by Gilead as Descovy.

Some eligible people in the UK can access an injectable – GSK's Apretude (cabotegravir) – which needs to be dosed every two months, but that is reserved for people at high risk who cannot reliably use daily oral tablets, for example, if they have social issues like homelessness or domestic abuse or have difficulty swallowing.

Richard Angell OBE, chief executive of 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, calling for Gilead to offer a lower price and NHS England to be prepared 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."

Photo by Ian Talmacs on Unsplash