The Lancet has published an editorial encouraging regulators and clinicians to ‘keep an open mind’ about lecanemab, the first drug aimed at slowing the progression of Alzheimer’s disease.
While lecanemab was approved by the US Food and Drug Administration (FDA) in 2023 and by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in August 2024, in September 2024, the UK’s National Institute for Health and Care Excellence (NICE) and the European Medicines Agency (EMA) voiced concerns over its safety. In our Regulatory Rapporteur poll in the same month, we asked if NICE should revise its decision and allow lecanemab to be prescribed on the NHS: 50% of respondents answered ‘No’ and only 19% answered ‘Yes’.
The EMA refused approval largely due to the possibility of it causing microhaemorrhages in the brain. NICE disallowed it due to this same risk and financial cost.
According to The Lancet: ‘As well as the cost of lecanemab itself (priced at US$27 500 per year in the USA), NICE factored in the cost of diagnostics, APOE [Apolipoprotein E] genotyping to establish treatment eligibility, fortnightly intravenous drug infusions, and periodic MRI scans to detect ARIA [amyloid-related imaging abnormalities], bringing the overall cost considerably above NICE’s threshold.’
The same article points out that the expensive scans could possibly be replaced with significantly cheaper blood testing, and intravenous infusions with cheaper and less-invasive subcutaneous shots. It encourages appraisal of the positive impact on families and carers as well as individual patients, although NICE is not allowed to consider the benefits to non-patients in its decision-making.
A further article in the Journal of Alzheimer’s Disease points out that the best results from Lecanemab are for early-onset patients and, while alternative, non-pharmaceutical treatments and lifestyle changes have clinically proven benefits, they are not promoted as pharmaceutical interventions.
Lecanemab is currently only available to private patients in the UK, at least until cheaper formulations are available.
Following the end of the consultation period for NICE’s evaluation, final guidance is expected in 2025.
