According to the American Medicines and Healthcare products Regulatory Agency (MHRA), the drug, also known as Lecanemab, is the first Alzheimer’s drug approved in the United States that shows signs of slowing the progression of the disease.
At the same time, the National Institute for Health and Care Excellence (NICE) published draft guidelines saying the drug was “not worth it to the taxpayer” due to its high cost and the need for intensive monitoring for side effects.
NICE also cited a lack of evidence on the long-term effects of the treatment, noting that the clinical trial only reported results where participants had taken lecanemab for 18 months.
It also highlights the complexity of a new class of drugs that benefit early-stage Alzheimer’s patients but carry the risk of rare and serious side effects.
NICE’s guidelines on the drug are open for public consultation until September 20. A final recommendation will be made after the responses have been evaluated.
NICE also said that around 70,000 adults in England would have been eligible for drug treatment.
Eisai and Biogen said they are working with NICE, the Scottish Medicines Consortium and the National Health Service to make Leqembi available “as soon as possible”.
Professor Paul Morgan, interim director of the UK Dementia Research Institute Cardiff at Cardiff University in Wales, said that while NICE’s decision would disappoint people who had high hopes for the new therapy, the organisation’s wait-and-see attitude was understandable given the “unanswered questions” about long-term effects and side effects.
Another dementia expert, Professor Vanessa Raymont, associate professor in the department of psychiatry at Oxford University, said that while new treatments for Alzheimer’s are crucial, blood tests to diagnose this memory disorder are equally important.
SIDE EFFECTS
The therapy is approved in the USA, China, Hong Kong, Israel, Japan, South Korea and the United Arab Emirates.
The companies said at the time that they would seek a review of the recommendation, but did not disclose what information they would provide to the regulator.
The infusion, administered twice a month, removes sticky clumps of the protein amyloid-beta from the brain, which are considered a hallmark of Alzheimer’s disease.
Some patients experienced serious side effects, including brain swelling and bleeding or microbleeds.
Leqembi treatment costs $26,500 per year in the US. In the UK, the NICE draft guideline states that the price is confidential until it is published by the UK Department of Health and Social Care.
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Reporting by Maggie Fick in London and Prerna Bedi in Bengaluru; Editing by Sherry Jacob-Phillips and Jane Merriman
Our standards: The Thomson Reuters Trust Principles.
