NICE and EMA say new Alzheimer’s drug is ‘not recommended’

Lecanemab, the first drug aimed at slowing the progression of Alzheimer’s disease, was approved by the United States Food and Drug Administration (FDA) last year and by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in August 2024, but UK’s National Institute for Health and Care Excellence (NICE) and the European Medicines Agency (EMA) have voiced concerns in the past two months over the drug’s cost-effectiveness and risk.

Lacanemab (brand name Leqembi) is an amyloid beta-directed antibody which is delivered to the patient via intravenous infusion. While the drug has performed well in an 18-month, Phase III trial, showing a delay in cognitive decline for about a quarter of patients, the new draft guidance from NICE states that Lecanemab is ‘not recommended’ and the EMA has recommended the refusal of the marketing authorisation for Leqembi.

The first concern is financial: the draft guideline from NICE on Lecanemab estimates that each infusion of the drug would cost £208, with NHS England estimating the cost to be closer to £565. Infusions lasting an hour must be administered every two weeks to every patient, and with 70,000 eligible patients in the UK, the cost to the NHS could be up to £1 billion per year.

The second concern is for the side effects of the drug. In July, the EMA said: “The most important safety concern with Leqembi is the frequent occurrence of …ARIA [Amyloid-Related Imagine Abnormailities], a side effect, seen in brain imaging, that involves swelling and potential bleedings in the brain.” ARIA, a severe and life-threatening side effect, was observed in 12.6% of patients in the recent trial.

The EMA emphasises, however, that its refusal does not impact ongoing clinical trials, and NICE is holding a public consultation until 20 September 2024 to review its guideline.

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