Alzheimer's patients in Britain's state-run health service may not gain access to Eisai and Biogen's new Leqembi drug, despite its approval by the country's regulator on Thursday. The Medicines and Healthcare products Regulatory Agency (MHRA) recognized the drug, also known as lecanemab, as the first treatment for Alzheimer's in the UK that shows some evidence of slowing disease progression. However, the National Institute for Health and Care Excellence (NICE) issued draft guidance stating that the drug's high cost and the need for intensive monitoring for side effects make it an inefficient use of taxpayer funds. NICE also highlighted the lack of long-term evidence regarding the treatment's effects, as clinical trials only reported outcomes after 18 months of use.
This decision comes as a setback for the drugmakers, who have faced slow uptake of the drug in the US due to similar concerns. It also underscores the challenges posed by a new class of drugs that benefit early-stage Alzheimer's patients but carry the risk of rare and serious side effects. NICE's guidance on the drug is open for public consultation until September 20, with a final recommendation to follow. Eisai and Biogen are collaborating with NICE, the Scottish Medicines Consortium, and the National Health Service to expedite the availability of Leqembi.
Professor Paul Morgan of the UK Dementia Research Institute at Cardiff University expressed understanding for NICE's cautious approach given the unanswered questions about the drug's long-term impact and side effects. Meanwhile, Professor Vanessa Raymont of the University of Oxford emphasized the importance of both new Alzheimer's treatments and diagnostic blood tests. Lecanemab showed a 27% reduction in Alzheimer's progression in a large trial, and while it has been approved in several countries, the European Union's drugs regulator rejected it last month due to the risk of serious brain swelling. The companies plan to seek re-examination of the EU's decision.
The treatment, administered twice a month, targets and removes sticky clumps of amyloid beta protein from the brain, which is believed to be a hallmark of Alzheimer's disease. However, it has been linked to serious side effects in some patients, including brain swelling and bleeding. In the US, Leqembi treatment costs $26,500 annually, while in Britain, the price remains confidential until officially published by the UK's Department for Health and Social Care. Currently, aside from Leqembi, only Eli Lilly's drug donanemab is available on the market for slowing the course of Alzheimer's disease.
