Leqembi's Cost-Effectiveness Challenge: NICE's Stance and UK NHS Access Constraints

The cost-effectiveness of Leqembi, an early Alzheimer’s disease treatment developed by Eisai and Biogen, has come under scrutiny by NICE in the UK. Despite being the first European country to approve its use, patients under the UK's National Health Services (NHS) will not have access to Leqembi due to its high costs.

According to draft guidance released on August 22 by the National Institute for Health and Care Excellence (NICE), an independent committee concluded that the cost-effectiveness estimates for Leqembi were significantly higher than what NICE considers an acceptable allocation of NHS resources. The committee highlighted uncertainties, including the lack of evidence on the long-term effects of Leqembi, the costs associated with treatment infusions, monitoring side effects, and determining the appropriate time to discontinue treatment.

NICE has requested additional information from both Eisai and NHS England to address these uncertainties. The information will be reviewed alongside comments from stakeholders in a subsequent meeting. In a separate announcement on August 22, Biogen shared that Eisai is collaborating with NICE, the Scottish Medicines Consortium (SMC), and the NHS to expedite the availability of Leqembi.

Leqembi is a dual-acting monoclonal antibody designed to target and eliminate amyloid beta aggregates, which are significant contributors to Alzheimer’s disease progression. The UK marketing approval for Leqembi was largely based on data from the Phase III CLARITY AD study. These findings also supported the traditional approval of the 100mg/mL injection of Leqembi by the US Food and Drug Administration (FDA) in July 2023.

Although Eisai and Biogen will jointly promote Leqembi in the UK, Eisai holds the marketing authorization and will manage its distribution.

Leqembi is anticipated to generate substantial revenue, with GlobalData forecasting $6.1 billion in sales by 2030. However, the drug’s approval journey has been complex. Despite positive long-term data presented by Eisai at the Alzheimer’s Association International Conference in 2024, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) did not approve Leqembi in late July. The CHMP cited that the drug’s benefits in slowing cognitive decline were insufficient to outweigh the risks of serious adverse events like amyloid-related imaging abnormalities (ARIA).

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

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