Like Aduhelm, Leqembi Faces Cost, Efficacy Concerns

Two Alzheimer’s disease drugs developed by Biogen Inc. — Aduhelm (aducanumab) and Leqembi (lecanemab-irmb), which are both meant to attack the buildup of amyloid plaque in the brain — have been met with skepticism by providers and payers. A new report by Tufts University researchers found that few commercial carriers cover Aduhelm, while the Institute for Clinical and Economic Review (ICER) concluded that Leqembi’s high price exceeds its expected clinical value — and one expert says that neither finding is surprising, given the controversies surrounding both drugs. 

The FDA on March 6 said that Leqembi, which Biogen developed in a joint venture with Eisai Co., Ltd., will have a full approval decision by July 6. In February, the agency granted Leqembi priority review; the drug gained an accelerated approval designation in January. Aduhelm, meanwhile, garnered accelerated approval in June 2021, despite broad controversy. Aduhelm's accelerated approval was broadly denounced by practitioners, and the HHS Office of Inspector General is investigating improper contacts between FDA staff and Biogen.