NICE says new Alzheimer’s drug donanemab ‘does not currently demonstrate value for the NHS’
The MHRA on Wednesday granted a license for Eli Lilly’s new Alzheimer’s treatment, donanemab, for use in adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
However, the drug will not be available on the NHS, as the National Institute for Health and Care Excellence (NICE) concluded that it “does not currently demonstrate value for the NHS.”
The health spending watchdog explained that the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, outweigh the relatively small benefits it offers to patients, and so it “cannot currently be considered good value for the taxpayer.”
Helen Knight, director of medicines evaluation at NICE, said: “For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers’ money.
Donanemab (also called Kisunla) is a monoclonal antibody drug given by infusion (through a drip in the arm). It targets and reduces beta-amyloid proteins, whose abnormal buildup is associated with Alzheimer's disease.
Clinical trial evidence suggests that the monthly injection can slow Alzheimer's disease progression by 4 to 7 months.
However, Knight said that this benefit is “just not enough to justify the additional cost to the NHS,” noting that the cost-effectiveness estimate for donanemab is 5 to 6 times higher than what NICE normally considers an acceptable use of NHS resources.
Acknowledging that this decision may be disappointing, Knight highlighted that Alzheimer’s treatment is an emerging field of medicine and that other therapies are being developed.
NICE’s independent committee pointed out significant uncertainties regarding the extent of donanemab's benefits and how long they last after treatment is stopped.
They also reviewed evidence of serious health risks, with a third of donanemab recipients experiencing amyloid-related imaging abnormalities (ARIA) caused by brain swelling and bleeding.
Additionally, they stressed the need for further work to understand the costs of giving the medicine in the NHS.
Eli Lilly and NHS England have been asked to provide additional information to address areas of uncertainty in the evidence.
Around 70,000 adults in England would have been eligible for donanemab treatment.
This is the second Alzheimer’s drug to be rejected by NICE in recent months. In August NICE declined lecanemab, another monoclonal antibody for mild Alzheimer’s.
The consultation period for the draft NICE guidance on donanemab will end on 20 November 2024.
The independent committee will review all feedback, including any new analyses, at a second meeting before issuing its final recommendations.
