Today, 7 July, The Scottish Medicines Consortium (SMC) have decided not to recommend lecanemab in the treatment of mild cognitive impairment and mild dementia due to Alzheimer’s disease in adults that are ApoEɛ4 heterozygotes or non-carriers. This affirms the SMCs prior decision on February 10.
The SMC provides guidance on the clinical and cost effectiveness of new medicines for use within NHS Scotland.
On their website, the SMC stated:
In a randomised, double-blind, phase III study, lecanemab reduced the cognitive and functional decline associated with early Alzheimer’s disease compared with placebo at 18 months. The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
ADI’s Member in Scotland, Alzheimer’s Scotland have commented on the publication of the guidance, highlighting it’s impact on those living with dementia. Alison McKean, Alzheimer Scotland’s Director of Policy and Research, said:
The decision by the Scottish Medicines Consortium not to recommend lecanemab for use by NHS Scotland is incredibly disappointing and shows that the current assessment process is in need of urgent change if we have any hope of tackling dementia.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 – it’s time to take a different approach. The current assessment process is ‘all or nothing’ and it’s very unlikely that any new dementia drug will meet its strict cost-benefit criteria.
This latest decision highlights the growing patchwork of regulatory and payer approvals for new disease-modifying treatments for Alzheimer’s disease around the world:
On the news, ADI CEO, Paola Barbarino said:
Today’s decision will come as a deep disappointment to people living with Alzheimer’s disease and their families in Scotland. As it stands, no disease modifying treatments are available in Scotland, while people living with dementia in other countries across the world are already accessing these new therapies. This growing disparity in regulatory decisions is deeply concerning. While safety must remain paramount, Alzheimer’s is a time-sensitive degenerative condition. The continued lack of treatment options within Scotland risks driving health disparities, or forcing those who can afford it towards health tourism.
ADI has been highlighting the rise in health tourism and the growing disparities in regulatory and reimbursement decisions through a targeted mini-campaign. As the campaign develops, today we are spotlighting the experiences of clinicians who are treating people living with dementia using new disease-modifying therapies.
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