New Alzheimer's drug could slow progression of the disease but approval for Scots is not guaranteed

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A new Alzheimer’s drug which could slow progression of the disease will not be considered for use in Scotland until at least next year.

And there are fears that the Scottish Medicines Consortium could follow the lead of NICE in England by rejecting the medicine, donanemab, on cost grounds. Therefore, only the richest in society would have access to the drug by means of a private prescription which is estimated to cost at least £25,000 a year.

It is the second medicine in just two months to have gained a licence from the Medicines and Healthcare products Regulatory Authority (MHRA) only to be rejected by NICE. The English drug authority also rejected lecanemab, the first treatment for Alzheimer’s licensed for use in the UK, in August on cost grounds.

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Lecanemab will also not be considered until next year by the SMC. And it could be another eight months before a decision is taken on donanemab. The news comes just days after a Scots dementia expert predicted scientists could find a cure for the condition within 10 years.

Professor Craig Ritchie told the Daily Record: “I don’t just expect a cure in 10 years, I expect that with new treatments dementia will be very rare.”

But he pointed out: “This new generation of treatments will have some quite serious side effects and they won’t suit everyone, and specialists will closely monitor patients in their care.

“But these are the first generation and more treatments - many being trialled now - will follow; second, third and fourth generations that will be even more targeted, safer and more effective.

“But you can’t have these second and later generation treatments without learning from the first generation.”

Donanemab is an antibody which binds to a protein called amyloid beta which form plaques in the brain with Alzheimer’s disease. The drug reduces these clumps, thereby, slowing the progression of the disease.

It works in a similar way to lecanemab and also involves the drug being infused in a clinical setting.

Because there have been issues with brain swelling and bleeding - which has led to the death of two volunteer trialists - patients need to be very carefully monitored while taking the medication.

Alzheimer Scotland’s Chief Executive Henry Simmons said it was “devastating” that the potentially life-changing treatment, has been blocked for NHS use in England and Wales.

He said: “Yet again people with dementia are being pushed to the back of the queue when it comes to NHS spending.

“We now have two approved treatments for Alzheimer’s available in Britain, yet neither will be widely available to the people who need them.

“It is incredibly frustrating and frankly unacceptable.

“NICE say the costs of providing donanemab are too high because of the need for regular infusions and monitoring for side effects.

“To deny people access on this basis is entirely unfair and simply upholds the serious neglect and unfair treatment of people who are at risk of, or living with dementia.

“It’s important to note that these treatments will not be for hundreds of thousands of people – those eligible will be small in number – so the costs of rolling out these drugs should be manageable.

“There are more dementia drugs in development and it would be unforgivable for regulators to continue blocking them simply because the NHS isn’t ready.”

He admitted that much work needed to be done to put the infrastructure and systems in place but he said: “We have known for years that these drugs are coming and it is inexcusable to hide behind a lack of preparedness.

“Making these drugs available on the NHS would also give us the opportunity to properly test them and see the real-life impact they could have.

“The NHS across the UK can – and must – do the work needed to open access to these treatments if vital progress is ever to be made.”

And he said he hoped the SMC would take “a different view and be prepared to build on the early work that has been done in Scotland to develop a Brain Health Clinic model, which is exactly the type of approach that will be needed going forward.”

NICE argued donanemab provides only a small benefit to patients by slowing cognitive decline by four to seven months in trials.

And while this could keep people living independently at home for longer, the body said it was not enough to justify the additional cost to the NHS.

Helen Knight, director of medicines evaluation at NICE, said:“I know this will be disappointing news but this is an emerging field of medicine and there are other treatments being developed.”

A spokesperson for the Scottish Medicines Consortium said: “It is the aim of the SMC to provide timely advice on the clinical and cost-effectiveness of all new medicines for NHSScotland.

“We are currently reviewing donanemab for the treatment of Alzheimer’s disease and expect to publish advice for NHSScotland in the first half of 2025.”

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