New Alzheimer's drug deemed too costly for UK's health service

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But in draft guidance published simultaneously, the National Institute for Health and Care Excellence (NICE), said the medicine's high cost and need for intensive monitoring for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 US 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.”

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.

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 US Food and Drug Administration last month.