Alzheimer’s drug rejected for NHS use: What is Donanemab?
A pioneering new drug, which has been shown to slow the advance of Alzheimer's, will not be available to patients on the NHS as Ian Woods reports.
A new "effective" Alzheimer's drug has been rejected for widespread use in the NHS in England after the health spending watchdog said it “does not currently demonstrate value for the NHS”.
Described as a "frustrating setback" by a charity, this is the second Alzheimer’s drug to be rejected by the National Institute for Health and Care Excellence (Nice) in a matter of months.
This comes as the Medicines and Healthcare Products Regulatory Agency (MHRA) said in August the drug, Donanemab, manufactured by pharmaceutical giant Eli Lilly, could be licensed for use in the UK.
Donanemab is a targeted antibody drug which slows the early stages of Alzheimer’s.
Alzheimer’s Research UK said Nice's announcement “risks signalling that the UK is no longer a good place to launch new dementia treatments”.
There are concerns that the decision could lead to a two-tier system for Alzheimer's patients - with those who can afford the drug able to access it privately while those relying on the NHS left without.Donanemab and another new drug for Alzheimer’s called Lecanemab, have been reported as a step forward in research as they target a cause of the disease, rather than just treating symptoms.
Alzheimer’s Research UK called the decision "disappointing" and added: “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.
“We’ve written to the Health Secretary again, calling for his leadership to bring together Nice, NHS England and industry so that people with dementia in the UK aren’t left behind."
On the decision, Nice’s director of medicines evaluation, Helen Knight, said: “For Nice to be able 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 Donanemab could slow down cognitive decline by four to seven 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.
“I know this will be disappointing news, but this is an emerging field of medicine and other treatments are being developed.”
What is Donanemab and how does it work?
Both Donanemab and Lecanemab are antibody drugs that binds to amyloid, a protein which builds up in the brains of those with Alzheimer’s disease.
By binding to the protein, the drugs help clear the build-up and slow cognitive decline.
Tests showed the drug reduced amyloid plaque on average by 84% at 18 months, manufacturer Eli Lilly said.
It can slow the rate at which memory and thinking decline by more than 20%.
Results also suggest the drug leads to a 40% reduction in the decline of everyday activities such as driving, enjoying hobbies and managing money.
A retired journalist, Peter Almond, who took part in the clinical trial for the drug said he now feels “as normal as a 78-year-old can be”.
"I can read, write, think, plan, walk, drive and even run," he said.
How are the drugs given?
Donanemab is given to patients via an intravenous drip once every four weeks.
Eli Lilly said some patients can complete their course of treatment in as little as six months once their amyloid plaque has cleared.
Are there any side effects?
Side effects of the Donanemab, and other similar drugs, can be serious.
Donanemab has been associated with "amyloid-related imaging abnormalities (ARIA)," which typically does not cause symptoms. However, if it does, it can be serious or even fatal.
Symptoms can include temporary brain swelling or micro-brain bleeds.
In one clinical trial published in the Journal of the American Medical Association in 2023, 24% of people receiving Donanemab had Aria.
Eli Lilly recommends that the risk should be managed “with careful observation, monitoring with MRIs, and appropriate actions if Aria is detected”.
Three deaths were reported among the people receiving Donanemab during the trial which were considered “treatment-related”, according to the 2023 paper.
One death was reported in the group who received the placebo – also known as a dummy drug.
The majority of side effects (82.4%) were either mild or were detected in tests but did not cause any symptoms.
How much does the drug cost?
Each vial of Donanemab , also known as Kisunla, costs $695.65 (£536.07), according to Eli Lilly.
The overall cost of Donanemab depends on how long the treatment is for each person.NHS England has published a briefing paper suggesting the cost of bringing new Alzheimer’s disease-modifying treatments to the health service could be £500 million to £1 billion per year.
How do I know if I am eligible?
NHS England estimates that between 50,000 and 280,000 patients might be eligible for the drug if it's approved for the NHS.
Potential eligible patients would need to have a baseline MRI scan and then either a PET-CT scan or lumbar puncture to confirm Alzheimer’s.
What have experts said?
When clinical trial results were reported in 2023, some experts said the findings were “incredibly encouraging”.
Others have been cautious with particular concerns raised about its potential side effects.
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