CMS: anti-amyloid drug Leqembi (lecanemab) doesn ’t meet the “reasonable and necessary” standard required for wider Medicare coverage

CMS Sticks to Sharply Limited Coverage of New Alzheimer’s Drug, Leqembi (Managed Healthcare Executive): For now, CMS (Note: Centers for Medicare & Medicaid Services) is sticking to the coverage decision it made for Aduhelm (aducanumab) and applying it Leqembi (lecanemab). The decision limits Medicare coverage of the two Alzheimer disease’s drugs to Medicare beneficiaries who have enrolled in clinical trials of the drugs The decision, which was announced in a press release yesterday, was denounced in strong language by the Alzheimer’s Association. “CMS’ role is to provide health care coverage” said Joanne Pike, Dr.Ph., the organization’s president and CEO, in a prepared statement. “Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary.” When CMS announced its “coverage with evidence development” for Aduhelm in April 2022, it said the policy would apply not just to Aduhelm but to “any future monoclonal antibodies directed against amyloid approved by the FDA with an indication for use in treating Alzheimer’s disease.” That announcement said CMS believes “important questions still need to be answered to support people with Medicare, caregivers, and their referring and treating physicians to make informed, appropriate decisions about use of any drug in this particular class” and that the data collected from having people enroll in trials “may be use...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health aducanumab Aduhelm Alzheimer's drug Alzheimers-Association amyloid CMS dementia FDA lecanemab Leqembi Medicare monoclonal antibodies Source Type: blogs