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The National Institute for Health and Clinical Excellence (NICE) has again rejected the use of Alzheimer’s disease (AD) treatments donanemab (Kisunla; Eli Lilly) and lecanemab (Leqembi; Eisai).
In final draft guidance, published on 19 June 2025, NICE ruled against the AD treatments for use in the NHS in England and Wales for the third time, after considering new evidence submissions.
According to a statement published alongside the final draft guidance, NICE said that its independent appraisal committee met to review new information submitted to the consultation but concluded that the benefits from the two treatments remain too small in people with mild cognitive impairment or mild dementia caused by AD to justify the additional cost to the NHS.
Donanemab and lecanemab are already licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for adult patients in the early stages of AD who have no copies — or one copy — of the apolipoprotein E4 gene.
Clinical trials have shown that the treatments delay progression from mild-to-moderate AD by around four to six months; however, NICE said the overall costs of purchasing and administering the drugs remain high.
NICE also noted that there is a lack of evidence on the long-term effects of the drugs and that patients receiving the treatments need intensive monitoring for side effects.
Helen Knight, director of medicines evaluation at NICE, said: “While we recognise the hope these treatments offer, the evidence shows they only provide modest benefits at best and substantial resources would be needed to enable access to them.”
She added that NICE’s independent appraisal committee recognised that any slowing of the disease getting worse would be meaningful for people with mild cognitive impairment or mild dementia caused by AD, and the news would be disappointing for many.
However, the small benefits, together with the substantial resources the NHS would need to commit to the treatments, means that, if approved, “they could displace other essential treatments and services that deliver significant benefits to patients”, she said.
In a statement issued on 19 June 2025, manufacturer of donanemab Eli Lilly said it would appeal the “disappointing” ruling.
“Lilly is disappointed with this final decision by NICE, which does not consider the full value of donanemab for patients, their caregivers and the healthcare system,” the statement said.
“Lilly will appeal against this decision on the grounds that the recommendation is unreasonable, based on the evidence Lilly, clinical experts and patient groups have submitted. Lilly remains confident in the clinical efficacy and cost-effectiveness of donanemab.”
Chris Stokes, president and general manager of UK and Northern Europe at Eli Lilly, said: “35 years’ research has delivered one of the first MHRA-authorised treatments in Alzheimer’s disease, giving donanemab the green light to help patients. However, NICE’s disappointing decision will block NHS patients in England from receiving it, limiting access to private patients only.
“If the system can’t deliver scientific firsts to NHS patients, it is broken. If the government is to deliver on its goals to reduce lives lost to the biggest killers and put Britain at the forefront of transforming treatment for dementia, it must keep pace with licensed medical breakthroughs”.
Rob Howard, professor of old age psychiatry at University College London, said it was unsurprising that NICE had confirmed its earlier view.
“Well-conducted clinical trials demonstrated that the actual size of benefits experienced by patients were too small to be noticeable, the treatment carries risks of side-effects, and the annual cost of the drugs and safety monitoring required would have been close to the cost of a nurse’s salary for each treated patient,” he said.
Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said: “The drugs’ modest benefits, combined with the significant costs of delivering them in the NHS, meant they faced insurmountable challenges.
“Without intervention from government, people with AD will continue to miss out — not because science is failing, but because the system is. [The] government must work with NICE, the NHS and industry to pilot licensed drugs, gather more data and prepare the health system for what’s ahead.”
Fiona Carragher, chief policy and research officer at the Alzheimer’s Society, said: “The reality we’re faced with is that these treatments remain out of reach of both the NHS and most eligible people with AD.
“In other diseases, like cancer, treatments have become more effective, safer and cheaper over time. It’s essential we see similar progress in dementia.”
Registered stakeholders have until 8 July 2025 to appeal against the final draft recommendations.
