With the successful accelerated US approval of lecanemab, Eisei and Biogen’s new Alzheimer’s drug, some worry the drug’s high price will limit access to many patients. The Institute for Clinical and Economic Review (ICER) estimated the drug’s value somewhere between $8,500 and $28,000 per biweekly treatment, well below the manufacturers’ estimated price of $26,000. Some worry it will go the way of the ill-fated Aduhelm.
According to Politico, “And at the moment, Medicare won’t foot the bill for beneficiaries seeking Leqembi. When Aduhelm received accelerated approval, the Centers for Medicare and Medicaid Services limited coverage for Aduhelm and drugs like it to patients enrolled in a trial. For those drugs that received accelerated approval, the trial would have to be randomized; for those that received traditional approval, it would have to be an observational patient registry. Since receiving accelerated approval, Eisai and Biogen have already asked the FDA to review additional clinical trial data to give Leqembi traditional approval. No Leqembi trials of any kind are currently planned.”
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(Source: Politico, January 10th, 2023)