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The National Institute for Health and Care Excellence (NICE) has opened a consultation on its third version of draft guidance for Alzheimer’s treatments donanemab (Kisunla; Eli Lilly) and lecanemab (Leqembi; Eisai).
The consultation, published on 31 March 2026, follows an appeal by the manufacturers of donanemab and lecanemab after NICE said it would not recommend the drugs for NHS use for a third time in June 2025.
In March 2025, NICE said it rejected the treatments because the cost of implementing donanemab and lecanemab across the NHS was “substantially higher” than considered acceptable for taxpayers’ money and NHS resources.
Appealing the decisions in January 2026, manufacturers said they did not have time to or were prevented from responding to certain parts of the decision-making process, such as the NHS’s estimation of administration costs.
According to NICE documentation, manufacturers also asked NICE to take into account long-term data on the drugs or the impact of the disease on caregivers, particularly on their mental health.
On 20 March 2026, the appraisal was returned to NICE “in order to allow further consideration of caregiver utilities and unpaid care costs, and to ensure that adequate opportunity is afforded to stakeholders to respond to the EAG’s critique on long-term data of donanemab and consider NHS England’s Infusion Cost Estimates document”.
According to the draft guidance consultation document, NICE has asked stakeholders to “respond to the external assessment group’s criticisms of the long-term extension data for donanemab in its critique of the company’s response to draft guidance and “NHS England’s Infusion Cost Estimates document”.
A spokesperson for one of the manufacturers told The Pharmaceutical Journal that they expected that the next committee meeting will use increased NICE cost-effectiveness thresholds that were announced in March 2026.
A spokesperson for Eisai told The Pharmaceutical Journal: “The appeal panel concluded that NICE’s approach ‘grossly under-estimated’ the impact caring for someone with Alzheimer’s disease has on carers. We know that Alzheimer’s disease places a profound burden on the family, friends and loved ones who so often provide care, and we agree with the appeals panel that the EQ-5D tool that NICE used is inadequate.
“In addition, the panel concluded that it was ‘unfair’ that Eisai was not given adequate time to review and respond to data which ‘informed the committee’s view decisively’ on the cost of delivering lecanemab infusions in the NHS.
“These two topics are part of a much wider appraisal for lecanemab, however both are key issues which were contested by Eisai and clinical experts at various stages of the process over the last three years. A fourth NICE appraisal committee meeting will allow these key topics to be re-examined, and we look forward to working with NICE & NHS England to address the remaining questions with the aim of making lecanemab available to eligible NHS patients in England as soon as possible.
“We are keen to work quickly with NICE to assess this treatment effectively, because while we wait, Alzheimer’s disease does not.”
Michelle Dyson, chief executive of the Alzheimer’s Society, commented: “We welcome NICE’s decision to look again at the case for lecanemab and donanemab, particularly at the significant impact of dementia on unpaid carers. We know that carers are too often pushed to breaking point, and this needs to be properly recognised.
“The government must be ambitious about preparing for new treatments in their upcoming dementia plan. Time is ticking and it’s important that people with dementia in the UK don’t miss out.”
The consultation will close on 28 April 2026. The committee will meet again on 10 June 2026 to evaluate the evidence.
