But it said 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The draft guidance will now go out to consultation until Sep 20, ahead of a final decision.
Must represent good use of taxpayers’ money
Helen Knight, director of medicines evaluation at Nice, 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 four to six 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.”
The MHRA had on Thursday approved a product licence for the medicine lecanemab (Leqembi) for use in the early stages of Alzheimer’s disease, saying this followed a thorough review of the benefits and risks.
It said the drug is the first treatment for Alzheimer’s disease licensed for use in Great Britain that shows some evidence of efficacy in slowing progression of the disease.
The decision was made with expert scientific advice on the benefit risk of lecanemab from the Commission on Human Medicines (CHM), the Government’s independent advisory body.
The drug is being licensed for patients who do not carry the ApoE4 gene.
The gene, which increases the risk of Alzheimer’s disease, have been found to have a greater risk of suffering amyloid-related imaging abnormalities (Aria), which are characterised by swelling and bleeding of the brain.
Patients taking some types of blood thinning medication will also be excluded, because of the increased risk of bleeds.
Safety under close review
Julian Beach, MHRA interim executive director, healthcare quality and access, said: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.
“We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.
“As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up.”
Ms Evans-Newton said further negotiations between Nice, drug manufacturer Eisai and the NHS might offer a way forward.
But she said: “The heartbreaking reality is that those who could benefit from drugs like lecanemab don’t have time to wait. We’ve written to the Health Secretary Wes Streeting urging him to act, and to find a solution so that people with dementia in the UK don’t continue to miss out on innovative treatments.
“As well as considering how to make drugs like lecanemab available, there also needs to be a real focus on improving the way dementia is diagnosed within the NHS. The shocking reality is that one in three people in England with dementia never get a formal diagnosis, leaving them unable to access the care and support they need.”