The National Institute for Health and Care Excellence (NICE) has recommended that donanemab is not approved for use on the NHS on the day that the Medicines and Healthcare products Regulatory Agency (MHRA) approved the drug as a new treatment for adults in the early stages of the condition who have one or no copies of the apolipoprotein E4 gene.
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 can not currently be considered good value for the taxpayer, NICE said.
It is estimated that around 70,000 adults in England would have been eligible for treatment with donanemab.
In a statement, Professor Fiona Carragher, chief policy and research officer at the Alzheimer’s Society, said that whilst the news was “disheartening”, the charity respected the decision.
Slowed Disease Progression
Dementia is the UK’s biggest killer, and around a million people in the UK are affected by it. By 2040, the Alzheimer’s Society estimates 1.4 million people will be living with the condition in the UK.
Donanemab is a monoclonal antibody that targets and reduces beta-amyloid proteins.
A review focusing on donanemab found that the treatment significantly slowed cognitive and functional decline in amyloid ‐ positive early symptomatic Alzheimer’s disease and lowered the risk of disease progression. Key safety risks occurred primarily within the first 6 months.
In reaching its recommendation, NICE focused on the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ trials, both of which found that donanemab treatment significantly slowed clinical progression at 76 weeks. In the TRAILBLAZER-ALZ trial, the Alzheimer’s Disease Rating Scale (ADRS) score change from baseline at 76 weeks was −6.86 with donanemab and −10.06 with placebo. In the TRAILBLAZER-ALZ 2 trial the change from baseline was -6.02 with donanemab and -9.27 with placebo.
NICE highlighted the significant health risks associated with the treatment: a third of donanemab recipients experienced amyloid-related imaging abnormalities caused by brain swelling and bleeding.
Too Costly for the NHS
The evidence showed donanemab can slow down cognitive decline by 4 to 7 months, “but this is just not enough benefit to justify the additional cost to the NHS ”,Helen Knight, director of medicines evaluation at NICE said in a statement.
“The cost-effectiveness estimate for donanemab is 5 to 6 times above what NICE normally considers an acceptable use of NHS resources,” she added.
“I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed,” Knight said.
Donanemab will now be available only for patients wishing to pay privately. It is already licensed in the US where treatment costs about £25,000 per year, rising up to £60,000 including monitoring and scans. It is unclear if this cost would have applied to NHS patients.
Although the news has frustrated patient advocates, the fact the drug received regulatory marketing authorisation has given them some hope for the future.
“Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia,” said Carragher. “MHRA’s approval of donanemab marks another milestone in this journey.”
Dr Rob Hicks is a retired NHS doctor. A well-known TV and radio broadcaster, he has written three books and has regularly contributed to national newspapers, magazines, and online.
