CMS Proposes to Restrict Medicare Coverage of Aduhelm to Patients in Clinical Trials

In a highly anticipated but not-so-surprising move, CMS on Jan. 11 released a proposed National Coverage Determination (NCD) that would restrict Medicare coverage of Biogen and Eisai, Co., Ltd.’s Aduhelm (aducanumab-avwa) and any other FDA-approved monoclonal antibodies that target beta amyloid plaque for the treatment of Alzheimer’s disease. Industry experts say the coverage proposal — coupled with a recent price cut on Aduhelm — is unlikely to alter commercial payers’ hesitancy toward covering the drug, while one actuary says the decision supports Medicare Advantage plans’ expectations that coverage would be limited.

According to the proposed NCD, which is now open to a 30-day comment period, Medicare would cover the therapies under Coverage with Evidence Development (CED), requiring that patients be enrolled in approved randomized controlled trials that are conducted in a hospital-based outpatient setting. Participants must have a “clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia; and evidence of amyloid pathology consistent with AD.” The NCD also would allow coverage of one beta amyloid positron emission tomography (PET) scan per patient as part of the protocol.