While approved by the Medicines and Healthcare products Regulatory Agency, the Alzheimer’s drug failed to win the backing of the U.K.’s National Institute for Health and Care Excellence, which said that its benefits were “too small to justify the cost.”
Biogen and Eisai announced on Thursday that Great Britain’s Medicines and Healthcare products Regulatory Agency has signed off on its anti-amyloid antibody Leqembi (lecanemab) for the treatment of mild cognitive impairment and dementia in Alzheimer’s disease patients.
However, the U.K.’s National Institute for Health and Care Excellence (NICE)—which provides guidance to the National Health Service (NHS) on what medicines to cover—found Leqembi’s benefits were “too small to justify the cost,” according to a news release.
“Lecanemab provides on average 4 to 6 months slowing in the rate of progression from mild to moderate Alzheimer’s disease, but this is just not enough benefit to justify the additional cost to the NHS,” Helen Knight, director of medicines evaluation at NICE, said in a statement. To support coverage for a particular treatment, “it must not only provide benefit to patients, but it must also represent a good use of NHS resources and taxpayers’ money,” Knight noted.
NICE on Monday also released its draft guidance—which is now open for public comment—noting that clinical trial data for Leqembi show that patients “continue to have worsening cognitive function over time,” albeit at a slower rate than placebo. There is also currently not enough evidence regarding Leqembi’s long-term effects, including after patients stop treatment, according to NICE.
Additionally, NICE said that incorporating Leqembi into the current practice for Alzheimer’s disease “would require significant changes to the existing diagnostic pathway,” including the need for new specialist diagnostic centers, the use of confirmatory tests for amyloid-beta status and genetic screening for APOE4.
Disease-modifying therapies, such as Leqembi, would also impose additional burden on primary care and memory clinics, which will have to adjust their treatment pathways for eligible patients to include the anti-amyloid antibody and corresponding screenings, follow-ups and management of toxicities, according to NICE.
First approved in the U.S. in January 2023, under the FDA’s accelerated pathway, Leqembi is a subcutaneously administered humanized IgG1 monoclonal antibody that targets amyloid-beta plaques in the brain and tags them for clearance. In July 2023, Leqembi became the first-ever anti-amyloid antibody to be granted full approval by the FDA.
Leqembi is also approved in other markets, including Japan, South Korea, Israel and China.
With Thursday’s approval, Leqembi is also the first Alzheimer’s disease treatment in the U.K. that can slow down disease progression, according to NICE. Great Britain is also the first European country to give Leqembi a regulatory green light, according to Biogen and Eisai.
Last month, the European Medicines Agency (EMA), which is the chief drug regulatory body of the European Union, declined to approve Leqembi, noting that “the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious adverse events.”
EMA pointed to amyloid-related imaging abnormalities (ARIA), which manifest as the swelling of and potential bleeding in the brain. While most ARIA cases were mild or presented no symptoms, some patients developed severe ARIA needing hospitalization.
