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The National Institute for Health and Care Excellence (NICE) has rejected a second Alzheimer’s disease treatment for use across the NHS in England and Wales.
In draft guidance published on 23 October 2024, NICE said that donanemab (Kisunla; Eli Lilly) did not provide good value for the NHS and that more evidence was needed on its clinical and cost-effectiveness for the treatment of mild Alzheimer’s disease.
The decision follows the publication of NICE’s draft guidance in August 2024, which rejected the use of lecanemab (manufactured by Biogen and Eisai), a monoclonal antibody. Evidence suggests the treatment can slow down the progression of cognitive decline in patients with Alzheimer’s disease by four to six months.
In a statement published alongside the draft guidance for donanemab, NICE said that clinical trial evidence suggests that monthly donanemab injections can slow Alzheimer’s disease progression by four to seven months.
“However, there are significant uncertainties about how much benefit donanemab provides, and how long this lasts for after stopping treatment,” it said.
“Further work is also needed to understand the costs of giving the medicine in the NHS.”
NICE added that the clinical trial evidence suggests that there are significant health risks associated with the treatment, with a third of donanemab patients experiencing amyloid-related imaging abnormalities caused by brain swelling and bleeding.
The organisation has asked the manufacturer and NHS England to provide additional information to address areas of uncertainty in the evidence.
On 23 October 2024, donanemab was licensed for the treatment of early stage Alzheimer’s disease by the Medicines and Healthcare products Regulatory Agency.
Commenting on NICE’s decision not to recommend the use of donanemab, Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said: “[This is] another frustrating setback for people affected by Alzheimer’s 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.”
Evans-Newton added that NICE’s decisions on lecanemab and donanemab “highlight uncertainty about their benefits compared to the significant costs of delivering them in the NHS”.
“Yet dementia remains the UK’s leading cause of death, and without action, an ageing population means more families will be affected, driving up NHS costs through emergency admissions and care,” she said.
Helen Knight, 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.”
The consultation on the draft NICE guidance on donanemab will close on 20 November 2024.
