By Maggie Fick
(Reuters) -Alzheimer's patients in Britain's state-run health service are unlikely to get access to Eisai and Biogen's new Leqembi drug, after it was approved on Thursday by the country's regulator but deemed too expensive for wide use.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the drug, also known as lecanemab, is the first treatment for Alzheimer's licensed for use in the country that shows some evidence of slowing the progression of the disease.
But in draft guidance published simultaneously, the National Institute for Health and Care Excellence (NICE), said the medicine's high cost and need for intensive monitoring for side effects "means it cannot be considered good value for the taxpayer".
NICE also cited a lack of evidence on the long-term effects of taking the treatment, noting that the clinical trial only reported outcomes when people had been taking lecanemab for 18 months.
The UK cost effectiveness body's findings mark the latest blow faced by the drugmakers amid slow take-up of the drug in the U.S. due to the cost and concerns over side effects and efficacy.
It also highlights the complexities 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 guidance on the drug is open for public consultation until Sept. 20, and a final recommendation will follow its evaluation of the responses.
NICE also said that around 70,000 adults in England would have been eligible for treatment with drug.
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.”
Shares of Biogen were down 1.3% at $203.52 in early trading.
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 with high hopes for the new therapy, the body's "wait and see" approach was understandable given what he called "unanswered questions" about the long-term impact and side effects.
Another dementia expert, Professor Vanessa Raymont, an associate professor in the psychiatry department at the University of Oxford, said that while new treatments for Alzheimer's are critical, blood tests to diagnose the memory-robbing disease are equally as important.
Experts and company executives told Reuters last year that while several such tests are in development, it will be another couple of years before they become an everyday tool.
SIDE EFFECTS
Lecanemab slowed progress of Alzheimer's disease by 27% compared with a placebo, in a large trial whose outcomes were reported by the companies in 2022.
The therapy has been approved in the United States, China, Hong Kong, Israel, Japan, South Korea and the UAE.
But last month the European Union's drugs regulator rejected the drug, saying the risk of serious brain swelling did not outweigh its small impact on slowing cognitive decline.
The companies said then that they would seek re-examination of the recommendation, but did not disclose what information they would provide the regulator.
An approval in Britain is a significant step in realizing the estimated $1.6 billion in revenue from Europe for Leqembi, "a critical approval that is needed to further accelerate sales for the drug," BMO Capital Markets analyst Evan Seigerman said.
The infusion, given twice a month, removes sticky clumps of protein amyloid beta from the brain, believed to be a hallmark of Alzheimer's disease.
It has been associated with serious side effects for some patients, including brain swelling and bleeding or microhemorrhages.
Leqembi treatment is priced at $26,500 a year in the U.S. In Britain, the NICE draft guidance stated that the price is confidential until published by the UK's Department for Health and Social Care.
For now, aside from Leqembi, there is only one other Alzheimer's drug on the market designed to slow the course of the disease: Eli Lilly's drug donanemab, approved by the U.S. Food and Drug Administration last month.
(Reporting by Maggie Fick in London and Prerna Bedi in Bengaluru, additional reporting by Sneha S K; Editing by Sherry Jacob-Phillips and Jane Merriman)
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