Eisai’s Alzheimer’s Drug Leqembi Deemed Too Expensive For NHS

The UK has become the first country in Europe to authorize the use of Leqembi (lecanemab), a drug developed by Eisai and Biogen for early-stage Alzheimer’s disease. However, patients within the UK’s National Health Services (NHS) will not have access to this treatment due to its high cost.

In draft guidance issued on 22 August, the National Institute for Health and Care Excellence (NICE) indicated that an independent committee found the drug’s cost-effectiveness estimates to be significantly higher than what is considered an appropriate use of NHS resources. The committee pointed out several uncertainties, including the long-term effects of Leqembi, the expenses associated with administering the treatment, monitoring potential side effects, and determining when to discontinue use.

NICE has requested further information from Eisai and NHS England to address these concerns, which will be evaluated in a subsequent meeting along with feedback from stakeholders. In a separate press release on 22 August, Biogen announced that it is collaborating with NICE, the Scottish Medicines Consortium (SMC), and the NHS to make Leqembi available as soon as possible, following the marketing authorization granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Leqembi is a monoclonal antibody designed to target and eliminate amyloid beta aggregates, a key factor in the progression of Alzheimer’s disease. The UK marketing approval was primarily based on data from the Phase III CLARITY AD study (NCT03887455), which also supported the US Food and Drug Administration’s (FDA) traditional approval of the 100mg/mL Leqembi injection in July 2023. Eisai, holding the marketing authorization, will distribute the therapy across the UK, while both Eisai and Biogen will be involved in promoting the drug.

The journey to approval for the blockbuster Alzheimer’s treatment has been anything but smooth. Despite Eisai showcasing encouraging long-term results for Leqembi at the 2024 Alzheimer’s Association International Conference (AAIC) earlier this month, the drug encountered a setback when the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) rejected its approval in late July. The CHMP noted that while Leqembi showed some benefits in slowing cognitive decline, these were deemed insufficient to outweigh the risks of severe side effects like amyloid-related imaging abnormalities (ARIA).

On a more positive note, the FDA accepted Eisai’s supplemental biologics application (sBLA) in June 2024 for the monthly IV maintenance dosing of Leqembi in Alzheimer’s patients. The agency has set a Prescription Drug User Fee Act (PDUFA) target date of January 25, 2025, for its decision.