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

by Lauren Flynn Kelly

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. 

CMS outlines NCD 

• 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.  

Payers will likely continue to limit coverage 

• “A lot of health systems were refusing to prescribe or administer Aduhelm for the time being, taking kind of a wait-and-see approach, and a lot of plans similarly were taking a wait-and-see approach, and I think this will just push them more towards limiting coverage unless there’s a stronger clinical case,” suggests David Mike, principal and consulting actuary with Milliman.  
• And while MA plans may have been surprised by CMS’s consideration of Aduhelm in Part B premiums, the proposal for limited coverage should reaffirm plans’ initial thoughts in terms of cost projections, he adds. 
• AHIP, for one, cheered the agency’s decision. “Americans deserve access to prescription drugs that are safe and effective, and we applaud CMS for putting patients first in their proposed coverage policy for monoclonal antibodies for treating patients with Alzheimer’s,” said AHIP President and CEO Matt Eyles in a statement.  
• “We agree with CMS that there is a need to obtain more clinical data on efficacy, which will be essential to ensuring these new medications deliver real value to patients before broadening access. We look forward to commenting in greater detail during the comment period,” added Eyles. 

From Radar on Medicare Advantage