Lecanemab has not been recommended for use in the NHS in England

The National Institute for Health and Care Excellence (NICE) has announced that Leqembi^® (lecanemab) has not been recommended for use in the National Health Service (NHS) in England and those devolved nations that follow such decisions^†1

Eisai will appeal against this decision and stands by the clinical and cost effectiveness of lecanemab in its licensed indication.² 

In August 2024, lecanemab became the first treatment that targets an underlying cause of Alzheimer’s disease to be approved in the UK.^2,3 It is authorised for the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers in the UK²

19 June, 2025 — Responding to today’s announcement by the National Institute of Health and Care Excellence (NICE) that it has not recommended Leqembi^®(lecanemab) for use in its UK licensed indication in the National Health Service (NHS) in England and those devolved nations that follow such decisions,¹ senior Eisai executives and expert Alzheimer’s doctors have issued the following statements. 

Professor Sir John Hardy, UK Dementia Research Institute London, said,

“It’s a shame that UK patients will not be able to access the treatment via the NHS in England, and I hope this decision can be revisited in the future. This is particularly the case given that the research which led to the development of anti-amyloid treatments was originally funded by the UK Government. It is important that patients in the UK and many other countries are able to feel the benefit of this research. We anticipate that real-world clinical data from countries where lecanemab has already launched will become available in the near future, so the role of the medicine in practice can be even better understood.”

Gary Hendler, Regional Chairman and CEO, Eisai EMEA, Senior Vice President & Global Corporate Officer, Eisai Co. Ltd, Tokyo, said,

“We are dismayed by today’s decision and very upset about what it means for people with Alzheimer’s disease and their families in England and those devolved nations that follow such decisions, both now and in the future. Alzheimer’s disease is the biggest killer in the UK,⁴ and the costs of managing it are set to double to £90 billion per year by 2040.⁵ Tackling Alzheimer’s disease is the biggest healthcare challenge in the world, and to do so successfully, all aspects of diagnosis and management, including focusing on the early stages of the disease, must be addressed.⁶”

“This decision protects a health service that is not yet ready to identify and manage patients in the early stages of their illness. On top of this, this outcome demonstrates that NICE’s appraisal process is simply not fit to evaluate medicines for early Alzheimer’s disease. There are currently over 130 new drugs in development for Alzheimer’s around the world.⁷ With 60% of thosefocused on the early stages of the disease,⁷ we feel it is our duty to sound the alarm today that this appraisal process needs an immediate overhaul so that future medicines may be more appropriately assessed, and patients and their families can have hope regarding future treatments.”

He added, “For the necessary change to happen in the management of Alzheimer’s disease in the UK, there needs to be genuine conviction to take real steps to achieve this across the whole healthcare system. As such, we call on the UK Government to meet with us and other stakeholders urgently to begin a robust national conversation about Alzheimer’s and agree the significant changes required if we are to provide people with early Alzheimer’s disease the care they need.”

Nick Burgin, President and COO President Global Value & Access, Eisai EMEA, said,

“The science and economics have been telling healthcare systems around the world for a decade or more that to address the challenge of Alzheimer’s disease, we must focus on early disease.^8,9 Unfortunately, we believe the NHS is not ready for this challenge, and worryingly, NHS England has so far failed to outline how, and how quickly, the service must adapt to become ready. Despite commitments and promises by successive different governments that they were preparing for a new era of managing Alzheimer’s disease, not enough has changed. There must be a real commitment to drive this change and it is clear that this is simply not a priority at the moment.”  

Regarding the NICE appraisal process specifically, he commented,

“Eisai has participated in this process fully and in good faith for over two years, providing all the information requested, answering all questions and working with NICE to enable appropriate NHS patients to access this treatment. We will appeal against this decision and categorically stand by the clinical and cost effectiveness of lecanemab in its licensed indication.²”

“However, with patient need so great and so many other potential medicines in development for early Alzheimer’s disease, we now also have a duty to call out what we believe are serious flaws of the NICE appraisal process. These include a failure to appropriately reflect the impact of the illness on family caregivers as well as the use of costs for giving the medicine to each patient that do not reflect the true cost of the resource required for this activity. For example, the EQ-5D assessment was used to assess health-related quality of life, however it undervalues the complex psychological, social and emotional toll of caring for someone with Alzheimer’s disease.^10,11 These and other flaws have led to this decision by tipping the balance so heavily towards costs and away from treatment benefits. The assumptions that NICE has chosen to use for their assessment mean that even if Eisai provided lecanemab to the NHS for free, it would still not meet NICE’s threshold for approval. This outcome demonstrates that the process is not fit for purpose and must be urgently reviewed so that other future medicines may be more appropriately assessed and have a realistic chance of benefiting patients and their families.”

Shaeed Chowdhury, Medical Director, Eisai UK and Ireland, said,

“This decision is a heavy blow for the Alzheimer’s disease community – not just for the patients and families but for all the healthcare professionals and researchers involved in Alzheimer’s disease. In 2023, lecanemab was granted the Medicines & Healthcare products Regulatory Agency’s Innovation Passport status under the UK’s Innovative Licensing and Access Pathway (ILAP) framework.¹² ILAP was designed to accelerate access to groundbreaking treatments for the most urgent, unmet needs.¹³ Yet today’s decision moves us further from that promise.”

“Patient groups have called for a managed access agreement which would allow some patients to use the new medicine via the NHS,¹⁴ to support the generation of experience and evidence that is needed to assess the full benefits of new dementia treatments. We feel that it is extraordinary to come out of a two-year NICE appraisal process for an ILAP-designated product without even a managed access agreement. It is even more extraordinary when the Innovative Medicines Fund, the managed access fund designed to specifically support the introduction of innovative non-cancer treatments, has so far only been used for a handful of medicines.¹⁵”

“Whilst these new treatments are not a cure, they are a beginning. Alzheimer’s disease progressively robs people of their memory, their independence and ultimately their dignity.¹⁶ For families already carrying the emotional and/or financial weight of Alzheimer’s disease, this is a frustrating setback.”

“At Eisai, we firmly believe that each day without real change in the management of Alzheimer’s disease incurs a greater financial and emotional cost for patients and their families, as well as imposing increased strain and pressure on the NHS and society.”

“We cannot afford to wait for a cure. Because, while we wait, Alzheimer’s doesn’t.”

Dr Elizabeth Coulthard, Professor of Cognitive Neurology, Bristol Medical School (Translational Health Sciences), said,

“We are still working hard to help people live well for longer by delaying symptoms of dementia. It is now really important that we find a way to deliver treatments equitably to people who will benefit most. I really hope a collaborative approach between the NHS, the pharmaceutical industry, charities and the public will eventually benefit the people I see in clinic every week who are experiencing the effects of early Alzheimer’s disease.”

*Apolipoprotein E is a protein involved in the metabolism of fats in humans. It is implicated in AD.¹⁷

^† Devolved nations which closely monitor and informally reference NICE outcomes in decision-making e.g. Wales and Northern Ireland.

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