The National Institute for Health and Care Excellence (NICE) has rejected a new drug that slows Alzheimer's, saying that its benefits ‘are too small to justify the cost’ to the NHS.
The decision comes despite the Medicines and Healthcare products Regulatory Agency (MHRA) saying that donanemab could be licensed for use in the UK. It is also the second disease-modifying Alzheimer’s drug, after lecanemab, to be rejected by NICE in a matter of months.
Helen Knight, the director of medicines evaluation at NICE, said: ‘Our independent committee looked at all the available evidence, including the benefits for carers. This shows donanemab could slow down cognitive decline by four to seven months, but this is just not enough benefit to justify the additional cost to the NHS. The cost effectiveness estimate for donanemab is five to six times above what NICE normally considers an acceptable use of NHS resources.’More on this topic:
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Donanemab, manufactured by pharmaceutical company Eli Lilly, is a targeted antibody drug that slows down the early stages of Alzheimer’s. Both donanemab and lecanemab bind to amyloid, a protein which builds up in the brains of people living with Alzheimer’s disease. By binding to amyloid, the drugs are designed to help clear the build-up and slow down cognitive decline.
Clinical trials by neuroscientists found that donanemab could slow the rate of memory decline by more than 20%. However, the drug has significant risks. Brain swelling was a common side-effect in up to a third of patients in the trial. For most, this resolved without causing symptoms, but two volunteers, and possibly a third, died because of dangerous swelling in the brain.
NICE cited these risks as one of the reasons for rejection. ‘I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed,’ said Ms Knight.
Charities have criticised NICE for disregarding the costs borne by families in providing care and accessing the drug from private clinics.
Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said the decision was a ‘frustrating setback’ for people living the disease.
‘We finally have two new treatments licensed in Britain for Alzheimer’s, but it’s incredibly disappointing that NHS patients in England and Wales won’t receive them. While these drugs are not cures and come with risk of side-effects, trials show they are the first treatments to slow the decline in memory and thinking skills linked to Alzheimer’s, rather than just alleviating symptoms.’
The charity has written to Wes Streeting, the Health and Social Care Secretary, ‘to bring together NICE, NHS England and industry so that people with dementia in the UK aren’t left behind’.