On April 7, 2022 CMS released its finalized policy for coverage of aducanumab (brand name Aduhelm) and any future monoclonal antibodies directed against amyloid for use in treating Alzheimer’s disease. CMS will cover the cost of Aduhelm for Medicare beneficiaries who: (1) have a clinical diagnosis of mild cognitive impairment due to Alzheimer’s Disease or mild dementia with a confirmed presence of plaque on the brain, and (2) are enrolled in approved clinical trials.

Despite aggressive, seven-figure PR campaigns and a rally on Capitol Hill to sway public opinion and the opinions of Congressional members and CMS staff, CMS’ final determination follows, in general, the draft decision made in January 2022. As a result of public comments received, CMS removed several initial requirements from its draft decision to provide inclusion of a broader range of qualifying people. Specifically –

• Criteria that excluded some groups of patients, such as those with Down’s syndrome, were removed from the final determination.
• The provision requiring the approved clinical trials to take place in hospital-based outpatient facilities was also removed.

Please see below for more information.