Alzheimer’s treatment rejected for second time for use by NHS in Scotland

An Alzheimer’s drug has been rejected for NHS use in Scotland for the second time in what campaigners insist is a “major disappointment”

The Scottish Medicines Consortium (SMC), which considers if new treatments can be used by the NHS, said that the evidence of the cost effectiveness of donanemab – which is also known under the brand name Kisunla – was “not sufficient”.

In the wake of the decision, Alzheimer Scotland called for a “dedicated dementia drug innovation fund” to be set up, to enable health bodies to “properly test any new promising treatment”.

The SMC had previously considered donanemab, but in July last year, but rejected it.

It comes after the UK’s medicines regulator said, in October 2024, 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.

Nice said that while the monthly injection can slow Alzheimer’s disease progression by four to seven months, the cost of providing it, including intensive monitoring for serious side effects, meant it was not considered good value.

Despite that, David Thomas, head of policy and public affairs for Alzheimer’s Research UK, said the SMC decision was “a major disappointment for people in Scotland living with early-stage Alzheimer’s”.

He added: “Donanemab isn’t a cure, but growing evidence from clinical trials and use of the treatment in other countries show long-term slowing of the progression of the disease, giving people more time with loved ones, while preserving independence and a better quality of life.

“By rejecting this treatment, another vital opportunity has been missed to build the systems, services and pathways the UK needs to offer disease‑modifying Alzheimer’s drugs.

“For families living with this devastating disease, every setback matters. We urgently need co-ordinated pilot programmes and a clear UK‑wide plan so new treatments can be assessed in the NHS and, ultimately, reach the people who stand to benefit.”

Alzheimer Scotland chief executive, Henry Simmons, said: “The decision by the Scottish Medicines Consortium not to recommend donanemab for use by NHS Scotland after reviewing further evidence on its effectiveness is devastating for people living with dementia, their families and carers.”

Mr Simmons said there was now an “urgent need for change in the system used to assess dementia drugs if we have any hope of tackling this disease”.

He added: “We understand that the SMC has established assessment protocols and criteria, however, we believe that moving from clinical trials into clinical practice based on the current process is not working.

“We would like to see a new element in the assessment process and that would be the introduction of dedicated pilot sites. These can be used to further test new promising treatments in meaningful clinical practice, before a decision on NHS provision is made.”

He added: “We need a dedicated dementia drug innovation fund to be set up in order to take this forward and properly test any new promising treatment.

“Dementia is the UK’s biggest killer and people living with this disease, their families and carers have been waiting decades for treatments that effectively slow its progression.

“We owe it to them to have an assessment process that gives promising new drugs a chance to show their true value and to realise their life-changing potential.”

SMC chair Dr Scott Muir said the health body “recognises the need for new therapies for Alzheimer’s disease”.

But he added: “Having considered all the evidence, the committee was still unable to accept donanemab for use in the NHS in Scotland.

“They felt that there remains uncertainty around what the modest clinical benefit means for patients and their families, and, in addition, the company’s evidence around its cost effectiveness was not sufficient.”

Pharmaceutical firm Eli Lilly said it was “disappointed” with the SMC decision.

In a statement, the company said: “Alzheimer’s disease is a leading cause of death in Scotland, and this decision leaves people living with Alzheimer’s disease without access to donanemab through the NHS.

“In a disease space where there have been no new treatments made available on the NHS in 20 years, Lilly remains confident in the clinical efficacy and cost-effectiveness of donanemab – and the value that it can bring to patients and to the NHS in Scotland.”

The SM also refused to approve a treatment for postnatal depression, and a treatment for pulmonary arterial hypertension (PAH) – a condition which causes abnormally high blood pressure in the arteries of the lungs.

Dr Muir said the SMC had been “unable to accept sotatercept for the treatment of adults with PAH”, adding that “the company’s evidence around the cost effectiveness of the treatment compared to currently available options was not sufficient”.

He continued: “The committee was also unable to accept zuranolone for the treatment of adults with postnatal depression as the company’s evidence around the cost effectiveness of the treatment compared to currently available options was not sufficient.”

Dr Muir said: “We were disappointed that we were unable to accept any of these medicines, however, it is SMC’s responsibility to ensure that only medicines that are clinically and cost effective are accepted for routine use in the NHS in Scotland.

“We would welcome resubmissions from the companies addressing the issues we have raised.”

Sotatercept is also known under the brand name Winrevair while zuranolone is sold under the name Zurzuvae.