Alzheimer's drug rejected due to widespread NHS use in England | Alzheimer

A new Alzheimer's drug has been rejected for widespread use in the health service in England after the health spending watchdog said it “does not currently demonstrate benefit to the NHS”.

The news comes as the UK Medicines Agency announced that donanemab could be approved for use in the UK.

It is the second disease-modifying Alzheimer's drug in a matter of months to be rejected by the National Institute of Health and Care Excellence (Nice).

Donanemab, made by pharmaceutical company Eli Lilly, is a targeted antibody drug that slows the early stages of Alzheimer's disease.

The drug and another new Alzheimer's drug called lecanemab are considered major advances in research because they target a known cause of the disease rather than just treating the symptoms.

Commenting on Nice's new draft guidance on rejection of the drug, Helen Knight, head of medicines evaluation at Nice, said: “For Nice to approve a medicine for use in the NHS, it must provide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 be representative of a meaningful use of the drug NHS resources and taxpayers' money.

“Our independent committee has reviewed all available evidence, including the benefits for carers. This shows that donanemab could slow cognitive decline by four to seven months, but this benefit is simply not enough to justify the additional cost to the NHS. The cost-effectiveness estimate for donanemab is five to six times higher than what Nice normally considers 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 and Healthcare products Regulatory Agency (MHRA), making it the first drug of its kind to be approved for use in the UK.

But Nice was quick to say that 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and sold under the brand name Leqembi, were “simply too small to justify the significant cost to the NHS”, and the draft guidance said the drug would not should be brought to market for widespread use across the NHS.

Concerns have been raised that the decision would lead to a two-tier system for Alzheimer's patients – with those who can afford the drug able to access it privately, while others who rely on NHS care remain excluded.

Both donanemab and lecanemab bind to amyloid, a protein that accumulates in the brains of people with Alzheimer's.

By binding to amyloid, the drugs are intended to help clear the deposits and slow cognitive decline.

There is evidence that people get the most benefit when they receive the treatment at an earlier stage of the disease.

Clinical trials on the safety and effectiveness of donanemab, also known as kisunla, found 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 percent reduction in decline in everyday activities such as driving, hobbies and money management.

The drug, given to patients via an intravenous drip every four weeks, carries a risk of side effects – some serious, including brain swelling and microcerebral hemorrhages.

Both donanemab and lecanemab have been approved for use in the United States, although the European Medicines Agency rejected lecanemab earlier this year.