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

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.

Thomas Moore

Science correspondent

@SkyNewsThomas

Donanemab is the most effective treatment yet for Alzheimer’s disease.

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.