{"id":54605,"date":"2026-09-09T12:21:58","date_gmt":"2026-09-09T12:21:58","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=54605"},"modified":"2026-09-09T13:59:02","modified_gmt":"2026-09-09T13:59:02","slug":"nice-fails-to-approve-lenacapavir-prep-will-feedback-reach-the-right-outcome-in-november","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/54605","title":{"rendered":"NICE fails to approve lenacapavir for HIV PrEP: will feedback lead to the right outcome in November?"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

On 9 September 2026, the National Institute for Health and Care Excellence (NICE) announced in a 28-page report, that a ground-breaking six-monthly injection, with close to 100% efficacy against HIV transmission, will not be available in England for people at high risk. [1]<\/strong><\/p>\n

In December 2025, lenacapavir was approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as being both safe and effective as PrEP for the prevention of HIV-1 in adults and adolescents, but without NICE approval, access on the NHS England remains blocked. [2]<\/p>\n

The science is not in question (despite the NICE document suggesting tangental evidence gaps). Lenacapavir studies reported the highest protection against HIV so far and extended results from phase 3 studies were updated at the AIDS 2026 conference in July. This included that less than a handful of people became HIV positive in the lenacapavir arms of two very large international studies, after many thousands of participant-years of follow-up. [3]<\/p>\n

The NICE announcement is therefore driven by drug pricing and for not meeting cost-effectiveness estimates. Even with significant discounts, the annual US list price for lenacapavir PrEP at $28,000 for two shots would never be affordable to a public health system. \u00a0The mark-up on manufacturing costs is also clearly a factor, given that generic companies have committed to making lenacapavir available in low-income countries for only $40 a year.<\/p>\n

However, the specific indication is a further complication in this case. \u00a0Cabotegravir injections (CAB-LA) were approved last October with a limited indications for use only in people who were unable to effectively use oral PrEP, set at ~1000 people annually, and Gilead did not accept this limitation, given the population benefits of 6-monthly PrEP are likely to be much wider. [4]<\/p>\n

Cost-effectiveness is also affected by numerous other decisions about the applicability of results from clinical trains in different settings, which can also generate blocks to approval.<\/p>\n

Nevertheless, there is also only likely to be a limited window period for injectable PrEP if the results of phase 3 studies of once-monthly oral alimatravir show high efficacy. Only needing to take a single oral pill might easily reduce the adherence advantages of injections. Missing this window by setting a price that further delays access doesn\u2019t benefit anyone. [5]<\/p>\n

comment<\/h3>\n

The lack of transparency in drug pricing is not helpful and limits general understanding in the overall approval process. There are no commercially sensitive reasons why this archaic approach to secrecy continues to be supported.<\/strong><\/p>\n

Details of negotiated prices are not disclosed, but, by definition, any new drug for an existing indications such as PrEP, must either match (or undercut) the current closest option or try to premium-price the new innovation (in which case this needs to be lowered to match).<\/strong><\/p>\n

The NICE announcement notes that the draft guidance is not fixed and that the decision on approval could change after further stakeholder consultations. The closing date for comments is 30 September 2026. This should enable both Gilead and NICE to reach a workable price. Although approval is related to many issues, a lower price would likely overcoome many of the challenges set by NICE.<\/strong><\/p>\n

The next hearing on lenacapavir PrEP is set for 3 November 2026, when the right decision for approval needs to be made. [1]<\/strong><\/p>\n

Today’s decisions will not affect participants in the ongoing PURPOSE 5 lenacapavir study for people who were not already accessing existing PrEP options. This study is now fully enrolled and includes seven UK sites. [6, 7]<\/strong><\/p>\n

Although Gilead has committed to providing future access to lenacapavir for all participants, a general principal of the Helsinki Declaration used to include that the benefits of research need to be accessible to the wider populations of countries that contribute to producing data that leads to drug approval.<\/strong><\/p>\n

For global access, MSF\/Doctor\u2019s Without Borders have launched a \u2019Two Shots $40′ campaign for Gilead to make lenacavavir available everywhere. [8]<\/strong><\/p>\n

Even though principally focussed on low- and middle-income countries, without a more realistic and affordable price for high-income countries, the incredible scientific advances from lenacapavir PrEP will remain high on an out-of-reach shelf for people in high-income countries, who are often from the least advantaged populations.<\/strong><\/p>\n

\n
References<\/div>\n<\/div>\n
    \n
  1. NICE. Lenacapavir for preventing HIV-1 in adults and young people. Draft guidance consultation. (9 September 2026).
    \nhttps:\/\/www.nice.org.uk\/guidance\/gid-ta11638\/documents\/draft-guidance<\/a> (PDF)<\/li>\n
  2. NICE. Lenacapavir for preventing HIV-1 in adults and young people [ID6495].
    \nhttps:\/\/www.nice.org.uk\/guidance\/indevelopment\/gid-ta11638<\/li>\n
  3. AIDS 2026: High efficacy continues in open label extensions to lenacapavir phase 3 PrEP studies. HTB (31 July 2026).
    \n    https:\/\/i-base.info\/htb\/54286<\/a><\/li>\n
  4. NICE approves limited access to injectable cabotegravir PrEP in England and Wales + BHIVA notes on prescribing. HTB (18 October 2025).
    \n    https:\/\/i-base.info\/htb\/52527<\/a><\/li>\n
  5. Merck announces alimatravir access programme ahead of AIDS 2026. HTB (24 July 2026).
    \n    https:\/\/i-base.info\/htb\/54297<\/a><\/li>\n
  6. NIHR. Study of Lenacapavir Taken Twice a Year for HIV Pre-Exposure Prophylaxis (PrEP).
    \n    https:\/\/bepartofresearch.nihr.ac.uk\/trial-details\/trial-detail<\/a><\/li>\n
  7. Gilead. PURPOSE 5 study.
    \n    https:\/\/www.purposestudies.com\/purpose5<\/a><\/li>\n
  8. MSF\/Doctor\u2019s Without Borders. Two Shots $40 Everywhere campaign.
    \n    https:\/\/www.instagram.com\/reels\/DdBjbKegzcK\/<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 9 September 2026, the National Institute for Health and Care Excellence (NICE) announced in a 28-page report, that a ground-breaking six-monthly injection, with close to 100% efficacy against HIV transmission, will not be available in …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[163,38,10],"tags":[],"class_list":["post-54605","post","type-post","status-publish","format-standard","hentry","category-early-access","category-treatment-access","category-transmission-and-prevention"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54605","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=54605"}],"version-history":[{"count":16,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54605\/revisions"}],"predecessor-version":[{"id":54621,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/54605\/revisions\/54621"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=54605"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=54605"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=54605"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}