In a move that at least one local HIV charity has deemed “profoundly disappointing,” England's health technology assessor NICE is currently recommending against coverage of Gilead Sciences’ landmark twice-a-year PrEP medication lenacapavir on the National Health Service (NHS).
In new draft guidance from the National Institute for Health and Care Excellence (NICE), the drug value watchdog suggested that lenacapavir should not win coverage for the taxpayer-funded NHS as an HIV pre-exposure prophylaxis (PrEP) med due to a confluence of what it called “uncertainties” in the drug’s clinical evidence and economic model.
The decision, which is not yet final, comes after the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) cleared lenacapavir to prevent HIV infection under the brand name Yeytuo back in December. Lenacapavir has also won prior approvals as a twice-yearly HIV treatment under the commercial moniker Sunlenca. It can now be used privately in England and the U.K., but NICE decides whether it should be funded by the NHS.
The drug was cleared as a new PrEP option under the name Yeztugo in the U.S. in June 2025.
A good deal of NICE’s rationale seemed to come down to the availability of other PrEP options already on tap in the U.K., noting that many people are able to rely on oral generics, while those who can’t take their medicine by mouth have the option of GSK’s cabotegravir—under the brand name Apretude—which is injected every two months.
The organization added that while clinical trial data have shown lenacapavir to cut the risk of HIV better than oral PrEP, it has not been directly compared in the clinic with cabotegravir, although indirect comparison suggests “that it is likely to work as well as this.”
At the same time, NICE flagged issues with the body of lenacapavir evidence, including how well the drug’s trial population reflects that of the U.K., as well as the number of people at high risk of getting HIV who do not have PrEP that would be expected to contract the virus.
NICE added that cost-effectiveness estimates for the drug are “above the range” it considers an acceptable use of NHS resources, further pointing to uncertainties in the product’s overall economic model, such as how many people might stop taking injectable lenacapavir in favor of an oral, as well as how to model the effect that getting HIV and having HIV treatment has on quality of life.
This is not the end of the story for NICE and lenacapavir. The drug value body plans to meet again on Nov. 3 to re-weigh the evidence and comments made over the coming weeks in response to its draft suggestion.
For its part, Gilead noted in an emailed statement that the decision is "disappointing for those who could benefit from additional HIV prevention options and for the broader HIV community."
"The appraisal process remains ongoing, and we are continuing to work with NHS England, DHSC and other stakeholders to support potential future access to lenacapavir for HIV prevention," a company spokesperson said. "We remain committed to advancing HIV prevention and expanding access to innovative prevention options."
In a statement issued Wednesday, U.K. HIV charity the Terrence Higgins Trust said the decision was “profoundly disappointing,” noting that the country “cannot repeat the mistakes made with oral PrEP, when delays and barriers to access meant people missed out on vital HIV prevention.” Currently in England, those wanting to access these drugs must do so via an online pharmacy or, predominately, through a sexual health clinic.
To ensure more optionality for patients seeking PrEP in the U.K., the Terrence Higgins Trust urged NICE to be transparent about what could change its mind, while adding the caveat that Gilead “must move on price so this innovation can be made affordable and accessible.”
Meanwhile, NHS must also be ready to commission appropriate volumes of the drug to make it available to those who need it most, the charity argued.
Fellow U.K.-based HIV charity HIV i-Base added in its own release that the “science is not in question” around lenacapavir’s merit in PrEP, noting that it holds that view “despite the NICE document suggesting tangential evidence gaps.”
In turn, the decision by NICE must mainly come down to pricing, i-Base’s Simon Collins wrote on Sept. 9, noting that the lenacapavir’s steep U.S. list price and manufacturing mark-ups are likely contributing to the issue.
Adding another wrinkle, i-Base noted that there may only be a “limited window period for demand for injectable PrEP,” citing looming results on other oral PrEP options that could further shift the treatment paradigm.
“Missing this window by setting a price that further delays access doesn’t benefit anyone,” the charity wrote.
Last year’s approval of Yeztugo helped propel Gilead’s HIV prevention business to sales of more than $1 billion—for the first time—in 2026’s second quarter. While much of that growth can be credited to Gilead’s daily pill Descovy, Yeztugo’s $232 million in second-quarter sales also topped analysts’ expectations by $17 million, or some 8%.
Still, analysts at the time questioned whether various factors, including the potential entry of new and appealing oral PrEP options, could stifle lenacapavir’s overall financial trajectory.
Outside of key markets, Gilead has also been taking strides to line up lenacapavir access in low- and middle-income countries, recently expanding its goal in April to reach an additional 1 million people in high-incidence, resource-limited nations, for a total pool of 3 million people through 2028.
The company has teamed up with multiple generics manufacturers in a bid to keep lenacapavir supply flowing, too.
Nevertheless, the company’s access plans have at times drawn criticism, including from Doctors Without Borders/Médecins Sans Frontières (MSF), which earlier this year called Gilead’s commitment “not nearly enough” to make a substantial impact on the global HIV epidemic.