June 19, 2025

expert reaction to final draft guidance on donanemab and lecanemab

Scientists comment on final NICE draft guidance on the use of donanemab and lecanemab for Alzheimer’s disease. 

Dr Sebastian Walsh, NIHR Doctoral Fellow in Public Health, University of Cambridge, said:

“We all want to improve the treatments available for people living with dementia, but I welcome this decision from NICE to reject use of these drugs for use in the NHS. Weighing up the evidence for the small effects of the drugs compared to their side effects and the cost and requirements to deliver them, it was almost impossible to see NICE reaching any other decision. Assessing cost-effectiveness is important, not because of a fixation with money and budgets, but because the resources required to deliver these drugs would have displaced resources available for other, badly needed services – including diagnosis and supportive care. With lecanemab and donanemab it was not simply a case of handing out the drugs to people. The minimum requirements to check who would have been offered the drugs would have included brain scans, genetic testing, and genetic counselling. And crucially, most people would have then been told that they weren’t eligible. 

“We need to do better for people living with dementia, and for their families; and that includes providing them with hope that there are things we can do – including supporting them to live at home for longer and reduce time spent in hospital. But ultimately, this doesn’t change what the science and the evidence tells us, that these drugs would not have been the right choice of precious NHS resources.”

Prof Siddharthan Chandran, Director of UK Dementia Research Institute, says:

“Naturally, there is disappointment that the first breakthrough treatments won’t be available on the NHS. However, this is still a watershed moment and the start of the story. We’ve shown it’s possible to slow Alzheimer’s, and that the disease is tractable. Through research, more affordable and more effective treatments and diagnostics are on the way – and at the UK Dementia Research Institute we’re working to make sure they will reach everyone who needs them.”

Prof Tara Spires-Jones, Director of the Centre for Discovery Brain Sciences at the University of Edinburgh, and Group Leader in the UK Dementia Research Institute said:

“While people living with Alzheimer’s disease and their families will likely be disappointed by this announcement that two new drugs that modestly slow Alzheimer’s progression will not be provided on the NHS, there is hope for safer, more effective treatments on the horizon.   Both lecanemab and donanemab effectively remove toxic amyloid pathology from the brain, but they only slow the progression of symptoms modestly.  Neither of these treatments improve symptoms and both come with the potential for serious side effects of brain swelling and brain bleeding.  Treatment with these drugs involves intravenous infusions and brain scans to monitor for side effects.  This combination of expensive and difficult treatment, potentially dangerous side effects, and modest benefits has led the NICE committee to decide against providing these drugs on the NHS, highlighting the need for more research to improve treatments.  There is ongoing work around the world including research in fundamental neuroscience to find new targets, clinical trials of new drugs, and studies of people taking lecanemab and donanemab to determine their long-term effects.  I am optimistic that research will lead to safer and more effective treatments.”

Prof Tom Dening, Professor of Dementia Research and Honorary Consultant in Old Age Psychiatry, University of Nottingham, said:

“The NICE guidance does not come as a surprise. I am completely in support. The benefits of these two expensive and unwieldy drugs are minimal and probably overstated by their advocates. They have significant side effects that require MRI monitoring.

“Given that we have growing waiting lists for under-provided memory assessment services, so people waiting for a diagnosis face significant delays, and given that post-diagnostic care in the public sector for dementia has been all but abolished, my humble personal view is that the monoclonal antibodies are not much more than a distraction from the real, relatively unglamorous challenge of providing people with dementia and their families with activities, care and support that we already know are beneficial for their mental and physical health.”

Prof Atticus Hainsworth, Professor of Cerebrovascular Disease, City St George’s, University of London, said:

“NICE is simply doing its job. The amyloid clearing antibodies give a nice demonstration that the needle can be moved in dementia. It’s worth remembering that trials of intensive blood pressure control showed a benefit similar to that seen in the amyloid antibody trials.”

Prof Charles Marshall, Professor of Clinical Neurology, Queen Mary University of London, said:

“This will be very disappointing news to people living with Alzheimer’s disease. However, the decision is understandable given the high cost to the NHS of giving the drugs for a relatively modest benefit. There are several things which would help to get disease-modifying treatments for Alzheimer’ disease approved in the future. Firstly, we need better information about the true impact of living with Alzheimer’s disease for both the person affected and their family, so that we can better capture all of the benefit on quality of life that these drugs might have. Secondly, we need improved NHS clinics that can offer high quality diagnosis and monitoring of dementia so that the costs of setting up this diagnosis and monitoring are not weighed against the benefit of the drugs. Finally, we need more effective drugs so that the magnitude of benefit becomes indisputable, and there is currently good reason to be hopeful about this.”

Prof Rob Howard, Professor of Old Age Psychiatry, UCL, said:

“Nobody should be surprised that NICE have confirmed their earlier view that the new Alzheimer’s disease treatments would not be cost-effective if used within the NHS. Well-conducted clinical trials demonstrated that the actual size of benefits experienced by patients were too small to be noticeable, 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.

“We need better treatments that can make an appreciable difference to the lives of people with dementia and these can only come from further research and study.”

Prof Paresh Malhotra, Head, Division of Neurology, Imperial College London, said:

“The draft guidance documents from NICE on lecanemab and donanemab mean that these treatments will not be available for people with Alzheimer’s Disease via the NHS. This is not totally unexpected but does create a significant gap between what is done in other countries as well as the private sector, and what will be done for NHS patients. The modest effects and significant costs of these drugs have, understandably, been used to justify these decisions. The treatments would require major infrastructure changes to deliver to all those who are potentially eligible. Perhaps the biggest impact (or lack of it), is that there will be no impetus to change our general approach to make dementia diagnosis faster and to provide longer-term specialist input for people living with Alzheimer’s Disease. New and initially controversial treatments catalysed services and healthcare provision for other neurological conditions such as MS and stroke. People with Alzheimer’s Disease, and Dementia more broadly, will have to continue to wait. In the meantime, we will try to push against the more nihilistic attitudes that are sometimes associated with this very common devastating disease.”

Hilary Evans-Newton, Chief Executive at Alzheimer’s Research UK, said:

“This rejection is a painful setback for people affected by Alzheimer’s — but sadly not a surprising one. The drugs’ modest benefits, combined with the significant costs of delivering them in the NHS, meant they faced insurmountable challenges. People with early Alzheimer’s in England and Wales now face a long wait for innovative new treatments as they won’t be able to access lecanemab or donanemab unless they can afford to pay privately.

“This decision sends a troubling signal to the life sciences sector — undermining confidence in the UK as a home for research, innovation and clinical trials. That risks lasting damage to both patients and the economy. NICE’s decision should ring alarm bells for a government that, only a year ago, pledged to make the UK a global leader in dementia treatments.

“While these drugs are not a cure and do come with potentially serious side effects, they represent an important first step in changing the course of Alzheimer’s. With over 30 Alzheimer’s drugs now in late-stage trials globally, momentum is building – and more will enter regulatory systems in the years ahead. Without intervention from government, people with Alzheimer’s will continue to miss out — not because science is failing, but because the system is. 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.

“One major barrier remains early and accurate diagnosis. Without it, patients can’t access current – or future – treatments. Alongside piloting, urgent investment in diagnostic services is vital if we are to give people a fair chance at the vast progress dementia research is making.”

Professor Fiona Carragher, Alzheimer’s Society’s Chief Policy and Research Officer, said: 

“There is no doubt that today’s decision is a setback for people with Alzheimer’s disease. It is highly disappointing that we are in a situation where treatments that slow the progression of the condition are not available on the NHS. 

“The reality we’re faced with is that these treatments remain out of reach of both the NHS and most eligible people with Alzheimer’s disease. In other diseases like cancer, treatments have become more effective, safer and cheaper over time. It’s essential we see similar progress in dementia.  

“The fact is, even if donanemab and lecanemab were made available on the NHS tomorrow, too many patients wouldn’t be able to access them because the health system isn’t ready to deliver them. The science is flying but the system is failing. 

“What we need now is for the UK government to commit to the long-term investment needed to fundamentally change dementia diagnosis so that we are ready for new treatments.  This relies on an early diagnosis and access to specialist diagnostic tests, yet currently a third of people with dementia don’t have a diagnosis at all.  

“The needs of people with dementia have long been overlooked and this cannot continue. We are heading towards a future where disease-slowing treatments reduce the devastating impact of dementia, and we cannot afford to delay preparing the NHS for them.” 

NICE published final draft guidance on donanemab and final draft guidance on lecanemab at 00:01 UK time on Thursday 19^th June. 

Declared interests

Dr Sebastian Walsh: No COI

Prof Siddharthan Chandran: The UK Dementia Research Institute holds funding partnerships with UK government (MRC, NIHR), charities (BHF, Alzheimer’s Research UK, Alzheimer’s Society, LifeArc, Parkinson’s UK), and industry (Lilly, Eisai, Astex, SPARC, GSK and Ono). Siddharthan Chandran until May 2025 was the academic lead of Neurii, a £5M partnership to deliver patient focused digital health solutions for dementia, part funded by Eisai.

Prof Tara Spires-Jones: I have no conflicts with this study but have received payments for consulting, scientific talks, or collaborative research over the past 10 years from AbbVie, Sanofi, Merck, Scottish Brain Sciences, Jay Therapeutics, Cognition Therapeutics, Ono, and Eisai. I am also Charity trustee for the British Neuroscience Association and the Guarantors of Brain and serve as scientific advisor to several charities and non-profit institutions.

Prof Tom Dening: I have no conflicting interests

Prof Atticus Hainsworth: AHH has received honoraria from Eli-Lilly and from NIA. He serves as a consultant for AriBio Co. Ltd and chairs the DementiasPlatformUK Vascular Experimental Medicine group.

Prof Charles Marshall: I have received personal fees from Lilly, Eisai and Roche

Prof Rob Howard: No COI

Prof Paresh Malhotra:

National Specialty Lead for Dementia and Neurodegeneration, NIHR Research Delivery Network

Honorary Consultant Neurologist, Imperial College Healthcare NHS Trust

Serviced Practice Consultant Neurologist, Cleveland Clinic London

NHSE Working Group Member (Lecanemab and Amyloid PET)

Trustee, Alzheimer’s Society

Recipient of ‘Drugs Only’ Grant for NIHR funded Trial, Shire/Takeda

Independent Data Monitoring Committee, J&J

Research funding from NIHR, ARUK, Alzheimer’s Society, MRC, DPUK, BHF, Lifearc, FIFA, FA, UK DRI

For all other experts, no reply to our request for DOIs was received.