Source: United Kingdom – Executive Government & Departments
Scientists comment on final NICE draft guidance on the use of donanemab and lecanemab for Alzheimer’s disease.
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“The draft guidance documents from NICE on lecanemab and donanemab mean that these treatments will not be available for people with Alzheimer’s Disease via the NHS.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 19th June.
Declared interests
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.