Scotland’s medicines review body has rejected a new early-stage Alzheimer’s drug, lecanemab, for use in NHS Scotland due to its high cost and “uncertainty” around its clinical effectiveness.

Announcing the latest Scottish Medicines Consortium (SMC) advice, Chair Dr Scott Muir said the committee were “unable to accept lecanemab” for treatment.

The drug was submitted for review by pharmaceutical company Eisai Ltd., as treatment for mild cognitive impairment and mild dementia in patients with Alzheimer’s disease that carry a particular protein.

Lecanemab works to clear toxic proteins from the brain to reduce the build-up associated with some forms of Alzheimer’s disease and preserve brain cells to delay the worsening of a patient’s condition, the SMC committee heard.

While it is the first disease-modifying medicine to be licensed for the treatment of early Alzheimer’s disease, the SMC concluded the clinical evidence presented involved a ‘high degree of extrapolation’.

The National Institute for Health and Care Excellence (NICE) rejected the drug last year.

Now, following suit, the SMC Chair explained “uncertainty” remains around the drug’s clinical effectiveness.

Dr Muir said:

“SMC welcomed the submission for lecanemab and recognises the need for new therapies for Alzheimer’s disease. Having considered all the evidence, we were unable to accept lecanemab for treatment in the NHS in Scotland.

“The committee felt there remains uncertainty around what the modest clinical benefit means for patients and their families, and, in addition, the cost-effective estimates supplied by the company were too high.”

The SMC report recognised the ‘significant carer burden’ associated with Alzheimer’s disease, but said that the company’s assessment may overestimate the benefits of lecanemab on carers.

Responding to the news, national charity Alzheimer Scotland said it is ‘disappointed but remain optimistic’ that further negotiations might bring a more positive outcome.

After the Scottish government launched its ‘Rethink’ dementia campaign, Alzheimer Scotland took the opportunity to urge SMC to accept lecanemab for use in Scotland.

Today, Alzheimer Scotland’s Chief Executive Henry Simmons said:

“We know this decision by the SMC will be disappointing for many people. This remains the first new drug shown to slow down the progression of Alzheimer’s disease, rather than simply treating the symptoms.

“Alzheimer Scotland will continue to do all that we can to represent the views of people living with dementia and their carers to ensure that the human costs and views of people with lived experience are reflected in this process.

“We remain optimistic that these initial hurdles will be overcome and, after decades of waiting, that new treatments will be approved for NHS use soon.”

Calculating cost

Mr Simmons and a former Scottish First Minister recently called for a national shift in dementia care, emphasising the cost currently being carried by families and unpaid carers.

The SMC decision was based on a cost-benefit analysis, weighing the clinical benefit of lecanemab against the cost of delivering the medicine to the patients who would be eligible.

In its report, the SMC says the estimated price of the drug is currently around £21,320 based on the need for IV-infusions every two weeks – with over 3,000 patients eligible for treatment.

Its adoption also requires diagnostic scans and genetic testing to check if patients are eligible for treatment, and brain MRI scans before and during treatment.

Clinical experts who fed into the SMC decision-making process highlighted that these requirements would make it ‘challenging’ to introduce lecanemab into practice.

SMC Chair Dr Muir said the medicines review body would “welcome a resubmission with changes to address the uncertainties” which has left charities hopeful for new drugs to come to light.

Alzheimer’s Research UK has said this decision highlights the need for the government, NHS leaders and industry to collaborate on “innovative approaches” to help people benefit from new treatments sooner.

Alzheimer Scotland’s Henry Simmons added that this is “not the end of the road for this potentially life-changing drug” and the opportunity for future discussions is part of a progressive NHS approach to treating Alzheimer’s disease.

Read more: “Get ready now” for advances in dementia care; Action needed on women’s brain health; Music’s potential to help with dementia; Scotland’s soccer aid spotlights Alzheimer's risk; Harnessing a parasite to take drugs into the brain; VR aids understanding of dementia; Redefining clinical meaningfulness