Today the Medicines and Healthcare products Regulatory Agency (MHRA) has approved donanemab for use in the UK to treat mild cognitive impairment or mild dementia due to Alzheimer’s disease in some adults. However, draft guidance released simultaneously by NICE has said that more evidence is needed on the clinical and cost-effectiveness of the drug, and therefore it will not be available on the NHS.
Donanemab is the second Alzheimer's drug to be approved by the MHRA, after lecanemab was approved earlier this year. Draft guidance by NICE states that the costs of providing donanemab, including the monthly infusions and intensive monitoring for serious side effects, balanced against the relatively small benefit it provides to patients, means it cannot currently be considered good value for the taxpayer.
In this case, NICE’s initial recommendation is that the benefits of the drug are not significant enough to make it cost effective, which means it will not be available to patients on the NHS. This will be disappointing to many. However, I do believe we are at a pivotal moment in our research mission to develop better, safer treatments.
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Here, UK DRI researchers respond to the news.
Prof Siddharthan Chandran, UK DRI Director, said:
“These first drugs are just the opening chapter for Alzheimer’s treatments. Today’s MHRA approval of donanemab is another step towards a future where we can begin to offer treatments to people affected by dementia. In this case, NICE’s initial recommendation is that the benefits of the drug are not significant enough to make it cost effective, which means it will not be available to patients on the NHS. This will be disappointing to many. However, I do believe we are at a pivotal moment in our research mission to develop better, safer treatments.
This is a long journey and is only possible because of long-term investment in research that underpins the identification and development of new treatments. The MRC-funded UK Dementia Research Institute is at the forefront of research into dementias, and working together with our many partners from patient charities, leading UK universities, the NHS and industry we are hopeful that major advances in diagnostics and treatments are ahead of us.”
Prof Tara Spires-Jones, Director of the Centre for Discovery Brain Sciences at the University of Edinburgh, Group Leader at the UK Dementia Research Institute, and President of the British Neuroscience Association said:
“While people living with dementia and their loved ones will undoubtedly be disappointed by the decision not to fund this new treatment on the NHS, the good news that new treatments can slow disease even a small amount is hopeful. New research is bringing us closer to treatments that should be safer and more effective. This decision on the amyloid targeting drug donanemab is not a surprise as it is consistent with the recent recommendations for lecanemab, a very similar drug. Donanemab is an antibody that removes amyloid pathology from the brain. This is not a cure. The treatment slows disease progression modestly but does not stop or reverse symptoms. The treatment also comes with potentially serious side effects of brain swelling and brain bleeding.”
Prof B. Paul Morgan, Group Leader at the UK Dementia Research Institute at Cardiff University, said:
“NICE has reached the decision that the Alzheimer’s drug Donanemab, despite having a modest effect on rate of disease progression, does not clear the clinical benefit and cost-effectiveness hurdles for approval for use in the NHS. The drug requires monthly infusions and carries significant risk of side effects, necessitating very close monitoring using imaging and other expensive tests.
“The decision is not surprising in that it closely mirrors that made for another Alzheimer’s drug, Lecanemab, in August. Both drugs are monoclonal antibodies that target amyloid, the main component of the plaques that develop in the brain in Alzheimer’s disease. They differ subtly in that Lecanemab targets the soluble form of amyloid to prevent plaque formation while Donanemab targets amyloid aggregates in plaques. Nevertheless, both efficiently clear amyloid and have a similar slowing effect on progression of cognitive decline in patients. Both also share the same risks, notably an increase in inflammation in brain blood vessels that can lead to bleeding in the brain.
“The decision will be a disappointment to Alzheimer’s sufferers and their carers. It means that there are no disease-modifying drugs for Alzheimer’s currently approved in the UK. The decision also highlights the problems with the amyloid-targeting drugs – eye-wateringly expensive, difficult to administer and potentially harmful. Balancing these against a modest impact on the disease, the decision made by NICE is understandable. These drugs are already in use in the US and elsewhere, albeit at lower than predicted uptake, and more will be learned from their wider use. In particular, improvements in patient selection and monitoring may tip the balance in the future.
“The final lesson from these disappointments is that we need better drugs for Alzheimer’s disease, moving beyond the focus on amyloid clearance and targeting other aspects of the disease that may provide better, safer and affordable routes to effective therapy of this awful disease.”
Declared interests
Prof Siddharthan Chandran: Siddharthan is the academic lead of Neurii, a £5M partnership to deliver patient focused digital health solutions for dementia, part funded by Eisai. The UK Dementia Research Institute holds partnerships with charities (BHF, Alzheimer’s Research UK, Alzheimer’s Society and LifeArc), and industry (Lilly, Eisai, Astex, SPARC and Ono).
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.
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