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The National Institute for Health and Care Excellence (NICE) has, for the second time, rejected the use of Alzheimer’s disease (AD) treatments donanemab (Kisunla; Eli Lilly) and lecanemab (Leqembi; Eisai) across the NHS in England and Wales.
In a press release published on 6 March 2025, NICE said that additional evidence, which had previously been requested by a NICE independent committee, “has confirmed that the medicines are not currently cost-effective and the committee’s recommendation remains that they should not be provided on the NHS at this time”.
Draft guidance for both donanemab and lecanemab are open for consultation, with NICE acknowledging that there is a “significant unmet need for treatment options to slow or prevent progression from mild cognitive impairment or mild dementia caused by AD”.
However, NICE added: “Cost-effectiveness estimates for donanemab and lecanemab remain substantially higher than we can consider an acceptable use of taxpayers’ money and NHS resources.
“The evidence presented so far shows neither donanemab nor lecanemab provide enough benefit to justify the substantial resources the NHS would need to commit to implement access to them, even with a managed access arrangement.”
Previous draft guidance on lecanemab and donanemab, published in August 2024 and October 2024, respectively, said in both cases that “more evidence was needed to generate robust cost-effectiveness estimates”.
Both treatments are already licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for adult patients in the early stages of AD. Donanemab and lecanemab can be used to treat people who have no copies, or one copy, of the apolipoprotein E4 gene (ApoE4).
However, the treatments cannot be prescribed for ApoE4 homozygous patients, who have two copies of that gene and make up around 15% of people diagnosed with AD.
The current NICE draft guidance for both treatments does not apply to people who are already prescribed either of the treatments on the NHS. Patients currently prescribed donanemab or lecanemab may continue taking the medicine unless they and their healthcare professional agree to stop.
Commenting on NICE’s latest draft guidance, Fiona Carragher, chief policy and research officer at the Alzheimer’s Society, said the recommendations “will remain disappointing for people eager to see these treatments readily available, though we continue to respect the decisions of the regulator”.
“We appreciate their rigour and flexibility in their review of the first disease modifying treatments for AD,” she said.
“We hope that learnings from this process will pave the way for future treatments, and with over 120 other drugs in trials for AD, we may see more drugs submitted for regulatory approval in the near future.”
The consultations on the draft NICE guidance on donanemab and lecanemab will close on 27 March 2025.
