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Medicare plans to cover the controversial, pricey Alzheimer’s drug Aduhelm, but only for certain patients enrolled in clinical trials, the agency announced on Tuesday. The proposed move would likely mean some patients will not be able to access the Biogen drug, which is the first Alzheimer’s treatment approved in nearly two decades. Since it got the green light this summer, doctors and scientists have raised questions about whether it actually works, government watchdogs have begun investigating whether the Food and Drug Administration followed proper procedure to approve it, and policy experts have questioned whether it is effective enough to justify its hefty price tag. (Cohrs, 1/11)

CMS said the Aduhelm studies must limit enrollment to patients in the early-stages of disease and have lab tests confirming that their brains have accumulated amyloid, a sticky protein linked to Alzheimer’s disease that Aduhelm is designed to clear. Medicare would pay for a single brain-amyloid scan under the policy. A final decision is expected in April following an additional 30-day comment period in which members of the public can weigh in on the proposed coverage policy. (Walker, 1/11)

The requirement for clinical studies applies to the entire class of drugs of which Aduhelm is a pioneer, monoclonal antibodies that work against amyloid, a kind of protein that forms plaques characteristic of Alzheimer’s disease. Biogen sharply disapproved of Medicare’s decision. The company said in a statement that the decision “denies the daily burden of people living with Alzheimer’s disease.” Randomized clinical trials “will exclude almost all patients who may benefit.” The company said clinical trials can take months to years to set up and “hundreds of Alzheimer’s patients...are progressing each day from mild to moderate disease stages, where treatment may no longer be an option.” (Alonso-Zaldivar, 1/12)

"This is unusual... but we believe it is appropriate for the Medicare population to issue this proposed decision," Tamara Syrek Jensen, director of the coverage and analysis group at the CMS Center for Clinical Standards and Quality, said in response to a reporter question on a Tuesday press call. Medicare beneficiaries participating in trials must have a clinical diagnosis of mild cognitive impairment due to Alzheimer's and evidence of amyloid pathology consistent with Alzheimer's. Beneficiaries can't have other conditions that would contribute significantly to cognitive decline, medical conditions likely to increase significant adverse side effects or be expected to die during the study. (Goldman, 1/11)