NICE agrees to look again at Alzheimer's drug Leqembi

Eisai will have an unprecedented third attempt to convince experts at UK medicines cost-effectiveness assessor NICE that the NHS should fund its Biogen-partnered Alzheimer's disease therapy Leqembi.

The company confirmed this morning that NICE has taken the "unusual decision" to hold a third appraisal committee meeting as part of its ongoing evaluation of Leqembi (lecanemab), which was turned down last year by NICE in draft guidance published just ahead of the drug's approval by the Medicines and Healthcare products Regulatory Agency (MHRA).

The UK approved the drug for treating mild cognitive impairment and mild dementia due to Alzheimer's in adult patients who have one or no copies of the APOE4 gene mutation (heterozygotes or non-carriers), which is a risk factor for the disease. These patients are thought to be at lower risk of amyloid-related imaging abnormalities (ARIA) – including brain swelling and bleeding – than people with two copies of the APOE4 gene variant.

In its draft guidance, NICE said that there was a "small but meaningful" benefit with Leqembi in these patients – a four to six-month delay in cognitive decline – but added that there was also little evidence of its long-term effects beyond 18 months.

The agency also said the cost of treatment with Leqembi, from the drug itself, as well as the need for regular infusions and intensive monitoring for side effects, was too high to justify its modest benefits. A second draft guidance document also arrived at similar conclusions.

"Eisai welcomes the opportunity for a second consultation period as a positive step forward in its ongoing dialogue with NICE to support medicine access for eligible patients," said the company, adding that NICE's panel will "need to consider significant changes to current diagnostic and treatment pathways to support management of early Alzheimer's disease (AD) patients."

The second consultation period has already begun and will conclude on 27th March, with the date of the third appraisal committee meeting scheduled for 14th May and a final decision due around 23rd July.

Nick Burgin, president of global value and access at Eisai EMEA, said: "We recognise that introducing a new class of medicine is not always straightforward; substantial changes are needed to improve Alzheimer's disease management and lecanemab is just one part of the bigger picture."

Biogen's UK and Ireland managing director, Kylie Bromley, added: "There is a critical need for innovative treatments to slow the progress of early Alzheimer's disease and preserve the identity and independence of those impacted for as long as possible. While the additional delay is disappointing news for this community, we are encouraged that the dialogue to secure reimbursement for lecanemab will continue."

In the UK, Eisai and Biogen co-promote Leqembi, with Eisai distributing the product as the marketing authorisation holder (MAH).

Eisai said recently that Leqembi sales were around $196 million in the first nine months of its current fiscal year and it expects to hit the full-year target of around $280 million for the drug.