Leqembi’s cost-effectiveness was called into question by NICE. Credits: Chinnapong / Shutterstock.com

Though the UK became the first country in Europe to authorize use of Eisai and Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), patients in the UK’s National Health Services (NHS) will not gain access to the drug as the anti-amyloid treatment was deemed too costly.

As per the 22 August draft guidance consultation released by the National Institute for Health and Care Excellence (NICE), an independent committee found that the cost effectiveness estimates were “considerably above what NICE considers an acceptable use of NHS resources.” The committee cited a lack of evidence on the long-term effects of treatment with Leqembi and the costs of providing treatment infusions, monitoring side effects, and determining when to terminate treatment as uncertainties.

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According to the guidance, NICE has requested additional information from Eisai and NHS England to address the uncertainties and will consider the additional information alongside stakeholder comments in a second meeting. In a separate 22 August press release announcing the UK Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorization of Leqembi, Biogen shared that Eisai is working with NICE, the Scottish Medicines Consortium (SMC), and the NHS to make Leqembi available as soon as possible.

Leqembi is a dual-acting monoclonal antibody designed to target and ablate amyloid beta aggregates that are a major driver of Alzheimer’s pathogenesis. According to Biogen’s announcement, the UK marketing approval was primarily based on data from the Phase III CLARITY AD study (NCT03887455); findings from which were the basis of a traditional approval of 100mg/mL injection Leqembi by the US Food and Drug Administration (FDA) in July 2023.

While Eisai and Biogen will both promote Leqembi across the UK, Eisai is set to distribute the therapy as its marketing authorization holder.

According to GlobalData’s consensus forecasts, Leqembi is expected to generate $6.1bn in 2030. GlobalData is the parent company of Pharmaceutical Technology.

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The blockbuster Alzheimer’s therapy is riding a complex roller-coaster for approval. Though Eisai presented positive long-term data for Leqembi at the 2024 Alzheimer’s Association International Conference (AAIC) earlier this month, the drug failed to gain approval from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in late July. The CHMP emphasized that Leqembi’s positive impacts on delaying cognitive decline were “not large enough” to justify the risks of serious adverse events such as amyloid-related imaging abnormalities (ARIA).

However, in June 2024, the FDA accepted Eisai’s supplemental biologics application (sBLA) for monthly Leqembi IV maintenance dosing in patients with Alzheimer’s disease. The agency has set a Prescription Drug User Fee Act (PDUFA) action date of 25 January 2025.