National Institute for Health and Clinical Excellence (NICE)
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Benefits of new Alzheimer’s treatment lecanemab are too small to justify the cost to the NHS
Our draft recommendation follows analysis of clinical trial evidence and reviewing the benefits of slowing disease progression, with the cost of treatment.
The benefits of the new Alzheimer’s drug lecanemab are too small to justify the costs, NICE said in draft guidance published today.
Lecanemab (also called Leqembi and made by Eisai) is for slowing progression in mild cognitive impairment or mild dementia due to Alzheimer’s disease (AD) in adults and has been licensed by The Medicines and Healthcare products Regulatory Agency (MHRA) today.
It is the first medicine to be licensed for Great Britain that has been shown to slow down progression of the disease, by between 4 and 6 months, NICE's independent committee heard.
However, the costs of providing the treatment, including fortnightly infusions in hospital and intensive monitoring for side effects, combined with the relatively small benefits it provides to patients means it cannot be considered good value for the taxpayer, the independent NICE committee has said.
Today we issued draft guidance for consultation not recommending lecanemab for use on the NHS because it is not a cost effective use of limited NHS funding. The independent NICE committee examined the available research trial evidence, real world data, and heard from patient representatives and their carers.
Dr Samantha Roberts, chief executive of NICE, yesterday said:
This is a new and emerging field of medicine which will no doubt develop rapidly. However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS. It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side effects, plus the cost of purchasing the drug.
Our independent committee has rigorously evaluated the available evidence, including the benefit for carers but NICE must only recommend treatments that offer good value to the taxpayer.
From the clinical trial evidence lecanemab has a small but meaningful – 4 to 6 months - effect on delaying cognitive decline when added to existing treatment.
And because the clinical trial only reported outcomes when people had been taking lecanemab for 18 months there is a lack of evidence on its long-term effects.
Helen Knight, director of medicines evaluation at NICE, yesterday said:
Lecanemab and other similar treatments for Alzheimer’s disease now coming on stream have prompted a great deal of debate about the prospects of being able for the first time to slow the effects of a condition that is progressive, life-limiting, complex and distressing.
For NICE to be able to approve a medicine for use in the NHS it must not only provide benefits to patients, but it must also represent a good use of NHS resources and taxpayers’ money.
Lecanemab provides on average 4 to 6 months slowing in the rate of progression from mild to moderate Alzheimer's disease, but this is just not enough benefit to justify the additional cost to the NHS.
It is estimated around 70,000 adults in England would have been eligible for treatment with lecanemab.
The public consultation on the draft NICE guidance will close on Friday 20 September 2024. The independent committee will consider all responses at a second committee meeting later in the year before producing its final recommendations.
Original article link: https://www.nice.org.uk/news/articles/benefits-of-new-alzheimer-s-treatment-lecanemab-are-too-small-to-justify-the-cost-to-the-nhs