Breakthrough drugs that slow the progression of Alzheimer’s disease will reportedly be refused for use on the NHS this week in a blow to thousands of patients.
The two drugs, Lecanemab and donanemab, slow down the decline in Alzheimer’s patients’ ability to carry out daily activities.
The drugs’ success in halting the progression of Alzheimer’s was heralded as a “new era” by campaigners and researchers.
However, the National Institute for Health and Care Excellence (Nice) is expected to refuse to recommend them on the NHS, according to The Sunday Times.
The regulator has already issued two decisions, one in October last year and another in March, saying they would not recommend the drugs for use on the NHS. A final decision will be published on Thursday.
Both drugs already have UK drug licences, making them available privately. It is estimated that around 70,000 adults in England would have been eligible for treatment if the drugs had been approved.
The regulator will reportedly turn down both drugs on the grounds of cost-effectiveness, with one insider telling The Sunday Times: “It is the end of the road for these drugs on the NHS”.
Lecanemab removes build-ups of the protein beta-amyloid from the brain. Trials showed that lecanemab can slow the progression of Alzheimer’s by 27 per cent over 18 months if given to someone early on in the course of their decline.
Donanemab, marketed as Kisunla in the UK, teaches the body’s immune cells to recognise and remove the amyloid protein, which builds up in the brains of people with Alzheimer’s disease.
The protein build-ups are thought to be toxic to brain cells, leading to the symptoms of Alzheimer’s, the Alzheimer’s society has said.
Lecanemab can, however, cause swelling and bleeding in the brain. In trials for Donanemab, a third of recipients experienced abnormalities in their brain scans caused by brain swelling and bleeding, NICE said.
The drugs reportedly cost around £20,000 to £25,000, with the NHS being offered a lower price. Privately, the treatment costs between £60,000-80,000 per year, according to Alzheimer’s Research UK.
In a previous review by NICE in October 2024, director of medicines evaluation Helen Knight said: “Donanemab could slow down cognitive decline by 4-7 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”.
While the regulator said the decision would be disappointing for some, “there are other treatments being developed”.
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said the decision to turn down the drugs would be “deeply disappointing”.
She added: “These treatments are not perfect, and we recognise the challenges they pose around cost, delivery and safety. But scientific progress is incremental, and these drugs represent a vital foundation to build on.”
The regulator NICE is due to publish the final draft guidance about the two drugs on Thursday. This leaves space for the decision to be challenged and sent to a review panel before the final guidance is published.
