Groundbreaking Alzheimer's drug rejected for widespread use on the NHS in England | British News

How donanemab works

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

By binding to it, the drug removes the deposits and slows a person's cognitive decline.

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

Clinical studies on the safety and effectiveness of donanemab 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, administered intravenously every four weeks, carries the risk of side effects such as brain swelling and microcerebral hemorrhages.

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

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

NHS England has published a briefing paper suggesting that the cost of introducing new treatments to treat Alzheimer's disease into the health service could be £500 to £1 billion a year.

The most effective Alzheimer's treatment to date – but it remains out of reach for most

Donanemab is the most effective treatment for Alzheimer's disease to date.

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

While the Medicines Safety Agency has given the green light, NICE, the agency that decides which drugs can be used in the NHS, has decided it is too expensive.

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

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

Your only option now is to pay for donanemab privately – in the United States that's about £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 say it would allow people in the early stages of the disease to live at home with a good quality of life for two years longer.

On the other hand, it may have serious side effects. Scans show signs of brain swelling and bleeding in about a third of patients.

This is draft guidance from NICE. In the past, there have been cases where an agreement was subsequently made with the manufacturer to make the drug more affordable.

That seems unlikely this time. The NHS does not have the scanners or staff to diagnose and monitor all the patients who could have used donanemab. It's a much bigger problem than just cost.

The glimmer of hope is that pharmaceutical companies appear to be pursuing the right goal.

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

There are around 20 other drugs in late-stage clinical trials. Maybe they'll be safer, more effective – and cheap enough for the NHS to prescribe them.