The new Alzheimer’s treatment donanemab does not demonstrate value for the NHS, NICE has announced. The news was met with dismay by clinicians and patient groups.

It is the second disease-modifying Alzheimer’s drug to be rejected by NICE in a matter of months following a similar decision made on lecanemab in August.

More evidence is needed on donanemab’s clinical and cost-effectiveness, the health spending watchdog said in draft guidance published today (October 23). It therefore will not recommend donanemab for NHS use, saying its benefits are too small to justify the additional costs.

These costs of providing donanemab, including the monthly infusions and 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, said NICE.

Clinical trial evidence has suggested that a monthly donanemab injection can slow Alzheimer’s progression by between four to seven months. However, “significant” health risks are associated with the treatment, says NICE. A third of donanemab recipients experienced amyloid-related imaging abnormalities (ARIA) caused by brain swelling and bleeding. 

Donanemab (Kisunla from Eli Lilly) has been licensed by the MHRA for treating mild cognitive impairment or mild dementia due to Alzheimer’s disease in some adults.

NICE acknowledged the importance of new treatment options in this field and has asked Eli Lilly and NHS England to provide additional information to address areas of uncertainty in the evidence. However, there are “significant uncertainties” as to how much benefit donanemab provides and how long this lasts for after stopping treatment

Helen Knight, director of medicines evaluation at NICE, said the cost-effectiveness estimate for donanemab is five to six times above what NICE normally considers an acceptable use of NHS resources. “I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed.”

It is estimated that around 70,000 adults in England would have been eligible for treatment with donanemab.

Both donanemab and lecanemab have been approved for use in the US, though the European medicines regulator rejected lecanemab earlier this year.

‘Frustrating’

Commenting on the announcement, Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said: “Today’s announcement marks 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. 

“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.