Leqembi enters second consultation period following NICE draft guidance update

NICE convenes third committee meeting for additional appraisal consideration

Eisai Europe Ltd. and Biogen Idec Ltd. announced that NICE will convene a third appraisal committee meeting for the ongoing evaluation of Leqembi® (lecanemab).

Lecanemab was authorised by the MHRA for treating mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD) in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers on 22 August 2024.

NICE continues to assess the cost-effectiveness of lecanemab and the associated costs of administering it to patients based on current NHS services and capabilities. Following discussions with Eisai and other experts, NICE determined that further consultation is required before finalising its guidance.

NICE’s interim second draft guidance does not recommend lecanemab for use within the NHS in England and Wales at this time. However, a second consultation period has begun and will conclude on 27 March 2025. The date of the third appraisal committee meeting is planned for 14 May 2025.

Nick Burgin, President & COO President Global Value & Access, Eisai EMEA, said: “We are encouraged by NICE’s decision to convene a third committee meeting as it enables further evaluation of lecanemab and how it could be introduced to the NHS. However, today’s decision means that eligible early Alzheimer’s disease patients in England and Wales still cannot access the medicine through the NHS.”

Eisai remains committed to working collaboratively with NICE and the NHS to enable eligible people living with early AD in England and Wales to access lecanemab as soon as possible.

Kylie Bromley, Biogen’s General Manager and Managing Director in the UK & Ireland, said: “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.”

AD is the leading cause of death in the UK. It progresses in stages causing loss of cognition, function, and independence. NICE noted the substantial burden of caring for someone living with AD and the significant role of carers and families.

Approximately 63% of the total cost of dementia care is shouldered by family members who are already experiencing the challenges of watching their loved ones health decline.

Carers can also experience tiredness, disturbed sleep, stress, and depression, and some leave paid employment to provide additional care. It is crucial that the wider societal impact of a disease like AD is taken into consideration when assessing the value of medicines.