Scottish Health Authority Rejects Alzheimer's Drug Donanemab Despite UK Regulatory Approval
Key Insights
The Scottish Medicines Consortium (search) rejected donanemab (Kisunla) for NHS Scotland use, citing uncertainty around the drug's modest clinical benefit despite UK regulatory approval in October.
This marks the second Alzheimer's drug rejection by Scottish authorities in three months, following a similar decision on lecanemab (Leqembi).
Alzheimer Scotland (search) advocates are calling for a specialized Dementia (search) Drugs Fund and reformed assessment processes, arguing current evaluation methods are inadequate for addressing the UK's leading cause of death.
The Scottish Medicines Consortium (search) (SMC) has rejected donanemab, marketed as Kisunla, for use on NHS Scotland, delivering what campaigners describe as a "devastating blow" to Alzheimer's patients and their families. The decision comes despite the UK's medicines regulator licensing the drug for use in October.
Dr Scott Muir, SMC chair, acknowledged the organization "welcomed the submission for donanemab and recognises the need for new therapies for Alzheimer's disease (search)." However, he stated that "having carefully considered all the evidence, the committee was unable to accept donanemab for treatment in the NHS in Scotland."
The SMC cited ongoing uncertainty about what the drug's "modest clinical benefit means for patients and their families" as the primary reason for rejection.
Second Major Rejection in Three Months
This decision follows a similar rejection three months earlier when the SMC declined to recommend lecanemab (Leqembi), another Alzheimer's drug, citing identical concerns about "uncertainty" around its "modest clinical benefit."
The pattern of rejections has prompted calls for systemic reform in how dementia (search) treatments are evaluated. Henry Simmons, chief executive of Alzheimer Scotland (search), argued that "the system used to assess dementia drugs must change if we have any hope of tackling this disease."
Mechanism and Clinical Impact
Donanemab operates through a targeted mechanism involving antibody infusions administered intravenously. These antibodies bind with amyloid (search) proteins that accumulate in the brains of Alzheimer's patients, triggering immune cells to clear the amyloid buildup and slow disease progression.
According to Alzheimer Scotland (search), both donanemab and lecanemab "have been shown to slow the progression of Alzheimer's disease (search) by as much as two years in some cases." The organization emphasizes that these represent the first disease-modifying treatments rather than symptom management approaches.
Call for Specialized Funding Framework
Simmons has proposed establishing a Dementia (search) Drugs Fund, modeled after existing specialized funding mechanisms. "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," he stated.
The advocacy reflects the scale of the challenge, with Simmons noting that "dementia (search) 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."
Patient Perspective on Assessment Challenges
Rynagh, a recently retired woman living with Alzheimer's, highlighted systemic gaps in dementia (search) care that complicate drug evaluation. "There aren't annual check-ups or anything like there are with other diseases. So there's no record of decline, which is unusual when you think about how progress is made with other diseases over time," she observed.
She emphasized the broader societal impact: "The burden on society, even in comparison to those other diseases, is tremendous. It's not just the individual, it's the community, it's the family."
Industry Response and Future Prospects
Manufacturer Lilly (search) contested the SMC decision, claiming it "does not consider the clinical efficacy and cost-effectiveness" of donanemab. The company's response suggests ongoing dialogue about the drug's value proposition may continue.
Despite the current rejection, there remains hope for reconsideration. The SMC's decision-making process allows for resubmission with additional evidence, potentially opening pathways for future approval.
The demographic trends underscore the urgency of the situation. As Rynagh noted, "66% of people with dementia (search) are women," and "the elderly population is getting bigger," creating what she described as a visible crisis requiring immediate attention and action.