Pioneering Alzheimer's drug rejected for widespread use in NHS in England

The announcement comes as the UK's medicines regulator said that donanemab could be licensed for use in the UK.

However, the health spending watchdog, the National Institute of Health and Care Excellence (NICE), said that it "does not currently demonstrate value for the NHS".

It is the second time a new Alzheimer's treatment has been rejected by NICE in a matter of months.

Manufactured by pharmaceutical giant Eli Lilly, donanemab, also known as Kisunla, is a targeted antibody drug that slows down the early stages of Alzheimer's.

Along with another new Alzheimer's drug called lecanemab, it has been billed as a huge step forward in research because they both target a known cause of the disease - instead of just treating the symptoms.

Commenting on new draft guidance rejecting the drug, Helen Knight from NICE said: "For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients,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 there are other treatments being developed."

In August, the Medicines and Healthcare products Regulatory Agency (MHRA) said that lecanemab was efficient in slowing down Alzheimer's and made it the first drug of its kind to be licensed for use in England.

However, NICE similarly said that lecanemab would not be rolled out across the NHS because the benefits are "just too small to justify the significant cost".

How donanemab works

Both donanemab and lecanemab bind to a protein called amyloid, which builds up in the brains of people living with Alzheimer's.

By binding to this, the drug works to clear the build-up and slow down a person's cognitive decline.

Evidence suggests that people get the most benefit from the drug if they receive it at an earlier stage of the disease.

Clinical trials testing the safety and efficacy of donanemab found it could slow the rate at which memory and thinking worsened 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.

The drug, delivered by an intravenous drip once every four weeks, does carry a risk of side effects including brain swelling and micro brain bleeds.

Both donanemab and lecanemab have been approved for use in the US - though the European medicines regulator rejected lecanemab earlier this year.

Each vial of the drug costs $696.65 (£536.51) but the overall cost of donanemab depends on how long a patient is on it.

NHS England has published a briefing paper suggesting the cost of bringing new Alzheimer’s disease-modifying treatments to the health service could be £500m to £1bn per year.

Concerns have been raised that the decision would lead to a two-tier system for Alzheimer's patients - with those able to afford the drug able to access it privately while others who rely on NHS care were left without.

Hilary Evans-Newton, chief executive at Alzheimer's Research UK, said: "Today's announcement marks another frustrating setback for people affected by Alzheimer's disease.

"We finally have two new treatments licensed in Britain for Alzheimer's, but it's incredibly disappointing that NHS patients won't receive them."

But it remains out of reach for the majority of patients in the UK.

While the medicines safety regulator has given it the green light, NICE, the body that decides which drugs can be used on the NHS, has ruled it is too expensive.

This will be devastating news for Alzheimer's patients and their families, who had been pinning their hopes on treatment that could slow the progression of their disease.

Around 70,000 people in the UK would have been eligible for treatment.

Their only option now will be to pay privately for donanemab – in the United States that's around £25,000 a year plus the cost of brain scans to monitor the drug's effects.

The ruling mirrors the decision on a similar drug called lecanemab in August.

But donanemab is even more effective. Some scientists have said it would allow people in the early stages of the disease to live at home with good quality of life for an extra two years.

On the other hand, it has potentially serious side effects. Around a third of patients have signs on scans of brain swelling and bleeding.

This is draft guidance from NICE and there have been instances in the past when a deal is subsequently done with the manufacturer to make the drug more affordable.

That seems unlikely this time. The NHS doesn’t have the scanners or staff to diagnose and monitor all the patients who could have used donanemab. It’s a much bigger problem than cost alone.

The glimmer of hope here is that the pharmaceutical companies seem to be chasing the right target.

Eliminating – or at least reducing – a rogue protein called amyloid from the brains of people in the early stages of Alzheimer’s disease is associated with a slowing of symptoms.

There are around 20 other drugs in late-stage clinical trials. Perhaps they will be safer, more effective - and cheap enough for the NHS to prescribe.

Professor Fiona Carragher, chief policy and research officer at Alzheimer's Society, said: "Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia.

"MHRA's approval of donanemab marks another milestone in this journey, but it comes alongside a draft NICE decision not to recommend donanemab for use on the NHS. While this is disheartening, we respect the decision of the regulator."

-SKY NEWS