ICER's analysis is slated to include two as-yet unapproved monoclonal antibody treatments, donanemab and lecanemab, as well as Aduhelm (aducanumab).
A final evidence report is scheduled to come out on Aug. 15
When the FDA approved Biogen’s controversial Alzheimer’s drug, Aduhelm (aducanumab), in June 2021, the Institute for Clinical and Economic Review (ICER) joined the chorus of criticism.
The cost-effectiveness group issued a statement that said that the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms.” Two months later, ICER came out with a pricing report that said the drug should be priced between $2,500 and $8,300 per year, which was far below the initial price of about $56,000 a year. Biogen announced in December that it was halving the price.
This year, ICER has Aduhelm in its sights again although this time the organization is comparing it with two other monoclonal antibodies that target the clumps of beta amyloid in the brain that many experts believe are the main cause of Alzheimer’s.
The two other monoclonal antibodies included in ICER’s review are Eli Lilly’s donanemab and Eisai's lecanemab. The companies submitted applications for FDA approval of both agents late last year, and the regulatory agency is scheduled to make a decision on whether to approve them this year.
According to a timeline on its website, ICER is accepting public comments on its scoping document for the three-drug review through Jan. 19. A draft evidence report is scheduled to come out May 10 andon August 15.