A new Alzheimer’s drug has been rejected for widespread use by the NHS in England after the health spending watchdog said it “does not currently demonstrate value to the NHS”.
The news comes as the UK medicines regulator said donanemab could be licensed for use in the UK.
It is the second disease-modifying Alzheimer’s drug that the National Institute of Health and Care Excellence (Nice) has rejected in just a few months.
Donanemab, manufactured by pharmaceutical company Eli Lilly, is a targeted antibody drug that slows the early stages of Alzheimer’s.
The drug, and another new Alzheimer’s drug called lecanemab, have been billed as a major step forward in research because they target a known cause of the disease, rather than just treating the symptoms.
Commenting on new draft guidance rejecting the drug, Helen Knight, director of medicines evaluation at Nice, said: “For Nice to approve a medicine for use in the NHS, it must provide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.
“Our independent committee looked at all the available evidence, including the benefits for carers. This shows that donanemab could slow cognitive decline by four to seven months, but this is not enough benefit to justify the additional cost to the The NHS 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.”
In August, lecanemab was approved by the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), making it the first drug of its kind to be licensed for use in the UK .
But Nice quickly said the benefits of lecanemab, made by Eisai and sold under the brand name Leqembi, were “too small to justify the significant cost to the NHS” and in the draft guidance, said the drug should not be launched . for widespread use in the NHS.
Concerns have been raised that the decision will lead to a two-tiered system for Alzheimer’s patients – with those who can afford the drug able to access it privately while others who rely on NHS care have been left without.
Both donanemab and lecanemab bind to amyloid, a protein that builds up in the brains of people living with Alzheimer’s disease.
By binding to amyloid, the drugs are thought to help remove the buildup and slow cognitive decline.
Evidence suggests that people get the most benefit if they are given treatment at an earlier stage of the disease.
Clinical trials testing the safety and effectiveness of donanemab, also known as Kisunla, found that it could slow the rate at which memory and thinking worsened by more than 20%.
The results also suggest that the drug leads to a 40% reduction in daily activities such as driving, enjoying hobbies and managing money.
The drug, which is given to patients through an intravenous drip once every four weeks, carries a risk of side effects – some of them serious, including brain swelling and microcerebral bleeding.
Both donanemab and lecanemab have been approved for use in the United States, although the European medicines regulator rejected lecanemab earlier this year.