A new Alzheimer’s drug has been rejected for widespread use by the NHS in England after the health watchdog said it “does not currently demonstrate value to the NHS”.
The news comes as Britain’s medicines regulator said donanemab could be licensed for use in Britain.
It is the second disease-modifying drug for Alzheimer’s disease to be rejected by the National Institute of Health and Care Excellence (Nice) within months.
Donanemab, manufactured by pharmaceutical company Eli Lilly, is a targeted antibody drug that slows the early stages of Alzheimer’s disease.
The drug, and another new drug for Alzheimer’s disease called lecanemab, are being heralded as a huge step forward in research because they target a known cause of the disease, rather than just treating symptoms.
Commenting on the new draft guidance rejecting the drug, Helen Knight, director of medicines evaluation in Nice, said: “For Nice to approve a drug for use in the NHS, it must provide additional benefits for patients, and it must also be representative for good use of NHS resources and taxpayers’ money.
“Our independent committee reviewed all available evidence, including the benefits for healthcare providers. This shows that donanemab could slow cognitive decline by four to seven months, but this is simply not enough benefit to justify the extra cost to the NHS. The cost-effectiveness estimate for donanemab is five to six times higher than what Nice would normally consider an acceptable use of NHS resources.
“I know this will be disappointing news, but this is an emerging area of medicine and other treatments are 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 Britain.
But Nice quickly said the benefits of lecanemab, made by Eisai and sold under the brand name Leqembi, were “simply too small to justify the significant cost to the NHS” and the draft guidelines said the drug should not be rolled out. for widespread use within the NHS.
Concerns were raised that the decision would lead to a two-tiered system for Alzheimer’s patients: those who could afford the drug would have access to it privately, while others who rely on NHS care would go without.
Both donanemab and lecanemab bind to amyloid, a protein that builds up in the brains of people with Alzheimer’s disease.
By binding to amyloid, the drugs are designed to help clear the buildup and slow cognitive decline.
There are indications that people benefit most if they receive treatment at an earlier stage of the disease.
Clinical studies on the safety and efficacy of donanemab, also known as Kisunla, have shown that it can slow the rate at which memory and thinking deteriorate by more than 20%.
The results also suggest that the drug leads to a 40% reduction in the decline in daily activities such as driving, pursuing hobbies and managing money.
The drug, which is given to patients through an IV once every four weeks, carries a risk of side effects – some of which are serious, including brain swelling and micro-bleeds in the brain.
Both donanemab and lecanemab are approved for use in the US, although the European drug regulator rejected lecanemab earlier this year.