NICE to reconsider lecanemab and donanemab following successful appeals

kellis
Fri, 20 Mar 2026 08:52:48 +0100

The UK's National Institute for Health and Care Excellence (NICE) has confirmed it will reconsider the two anti-amyloid therapies lecanemab and donanemab, after appeal panels upheld key grounds of appeal submitted by both manufacturers against the most recent rejection.In June 2025, NICE rejected both drugs after an unprecedented third appraisal, concluding that the clinical benefits in people with mild cognitive impairment or mild dementia due to Alzheimer's disease were too modest to justify the additional cost to the National Health Service (NHS). The appeal panels, which were organised on 13 and 14 January 2026 respectively, upheld several grounds in both cases. For lecanemab, the panel found that Eisai had been given insufficient time to respond to NHS England's infusion cost estimates document prior to the third committee meeting, and that the committee's assessment of carer utility values was unreasonable given the weight of evidence that the EQ-5D instrument grossly underestimated the impact of Alzheimer's disease on carers. For donanemab, the panel upheld equivalent findings on infusion costs and carer utilities, and additionally found that Lilly had been prevented from responding to the EAG's critique of long-term data, and that the committee had failed to consider unpaid care costs through a non-reference case scenario analysis.The appraisals are now remitted to the committee for reconsideration of these specific points. The dates for the next committee meetings have not yet been confirmed. The Alzheimer's Society welcomed the decision, with Chief Executive Officer Michelle Dyson saying: "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 Alzheimer’s Society also noted that the science is moving rapidly and that, globally, more people are beginning to access these drugs, while the UK is falling behind. With over 30 Alzheimer's disease drugs currently in late-stage clinical trials, further treatment applications to regulators are expected in the near term. Appeal documents for lecanemab and donanemab can be found here: Lecanemab: https://www.nice.org.uk/guidance/indevelopment/gid-ta11220/documents Donanemab: https://www.nice.org.uk/guidance/indevelopment/gid-ta11221