Biogen's Leqembi has questionable efficacy, cost effectiveness, ICER says
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The net benefit of Biogen (NASDAQ:BIIB) and Eisai's (OTCPK:ESALF) Alzheimer's treatment Leqembi (lecanemab) is uncertain, and may even cause harm, according to a final evidence report from a key non-profit organization that evaluates medications.
Although the Institute for Clinical and Economic Review rated treatment with Leqembi for cognitive impairment due to Alzheimer's "promising and inconclusive," it also warned that the drug has been associated with a condition characterized by brain bleeding and/or swelling.

In one of the companies' pivotal trials for Leqembi, the condition, amyloid-related imaging abnormalities (ARIA), was seen in 21.5% of patients on the medication compared to 9.5% in the placebo group.
"However, given the risks of brain swelling and bleeding, particularly when lecanemab is used outside of clinical trials, our report concluded that significant uncertainties remain as to whether the average benefits of lecanemab will exceed its risks," ICER Chief Medical Officer David Rind wrote.
The report also found that Leqembi's list price of $26.5K annually significantly exceeds ICER's Health Benefit Price Benchmark of $8.9K-$21.5K.
"In addition, using the best current data from the clinical trials, at its announced list price lecanemab exceeds typical thresholds for cost-effectiveness," Rind noted.
Leqembi received accelerated approval from the US FDA in January.
Most of the treatments under development for Alzheimer's are targeting amyloid plaque typically found in the brains of patients. Although surrogate endpoints for efficacy in trials are based on clearing of this plaque, ICER argues that may not be the best assessment.
"We remain uncertain that amyloid removal is an appropriate surrogate outcome for clinical benefit and instead look to the clinical outcomes found in randomized trials," the report states.
The next catalyst for Leqembi could come later this year if the FDA grants full approval for the drug. If the agency does, it would likely greatly influence the Center for Medicare and Medicaid's decision whether or not to cover the drug for Medicare enrollees.