Rejection of Alzheimer’s drug for use in Scotland is 'devastating blow'

A new Alzheimer’s drug has been rejected for use on the NHS in Scotland – with campaigners insisting the decision is a “devastating blow” for those affected by the condition.

The head of the charity Alzheimer Scotland spoke out after the Scottish Medicines Consortium (SMC) announced it would not recommend donanemab, also known under the brand name Kisunla, for use by NHS Scotland.

The decision comes after UK’s medicines regulator said in October that the drug could be licensed for use in the UK.

However, the National Institute for Health and Care Excellence (Nice) has already refused to grant approval for it to be used by the health service in England.

SMC chair Dr Scott Muir said it had “welcomed the submission for donanemab and recognises the need for new therapies for Alzheimer’s disease”.

But he added: “However, having carefully considered all the evidence, the committee was unable to accept donanemab for treatment in the NHS in Scotland.”

Dr Muir said the SMC “considered that there remains uncertainty around what the modest clinical benefit means for patients and their families”.

It comes three months after the SMC similarly decided not to recommend another Alzheimer’s drug, lecanemab, known under the brand name Leqembi, for use on the NHS, with the organisation saying then there was “uncertainty” around the “modest clinical benefit” it could bring patients.

In the wake of those decisions, Henry Simmons, chief executive of the charity Alzheimer Scotland, said there needs to be a change in the system used for assessing such drugs – and suggested a dementia drugs fund be set up to “finally tackle the UK’s biggest killer head-on”

Mr Simmons insisted: “It’s our view that the system used to assess dementia drugs must change if we have any hope of tackling this disease.”

He described the SMC’s decision to not recommend donanemab as being “yet another devastating blow for people living with dementia, their families and carers”

He said while there was an “established assessment process” for determining what new treatments can be used by the NHS, drugs such as “donanemab” are “extremely new”.

Calling for the assessment process to change for dementia treatments, he added: “Dementia is the UK’s biggest killer, and the leading cause of death for women.

“More than 75,000 people die from this disease every year – and yet we still don’t have either of the promising new treatments that have been approved in the past year available on the NHS.

“Donanemab is the second disease-modifying drug, after lecanemab, to be approved as safe. Both have been shown to slow the progression of Alzheimer’s disease by as much as two years in some cases.

“But we seem to be stuck in a vicious cycle where each time a new drug is assessed, the regulator states that the evidence provided by the company on how well the medicine works, along with how much it would cost to use it, was not strong enough.

“It is time to take a different approach to the way dementia drugs are assessed for NHS use – one that takes into account the sheer size and scale of this disease and the enormous impact it has on the lives of individuals, their families and carers.”

The Alzheimer Scotland boss said: “There is a special case to be made here for dementia treatments to be supported by alternative forms of funding from governments to get these treatments into the NHS and into the hands of those who need it most.

“In the same way that the Innovative Medicines Fund or Cancer Drugs Fund provide access to treatments deemed too costly for the NHS, we believe it is time to set up a Dementia Drugs Fund to finally tackle the UK’s biggest killer head-on.”