On January 11, 2022, CMS released a proposed National Coverage Determination (NCD) decision memorandum which would cover monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED). This means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in a qualifying clinical trial and it must be administered in a hospital outpatient setting. The proposed NCD is open to public comment and comments can be submitted until February 10, 2022 at the NCD database for CAG-00460N: https://www.cms.gov/medicare-coverage-database/view/nca.aspx?ncaid=305&bc=0. CMS anticipates a final decision by April 11, 2022.
Currently Aduhelm is the only monoclonal antibody directed against amyloid beta approved by the FDA for the treatment of Alzheimer’s disease receiving approval on June 7, 2021. Initially the pharmaceutical company, Biogen, announced that the selling price would be $56,000 per patient per year. However, in December 2021, the company announced that it was cutting the price in half to $28,000 per patient per year.
The cost and coverage has not been without controversy. As the target population is Medicare-age, CMS recalculated the premium costs for Part B coverage at the initial selling price, with Part B premiums increasing 14.5% in 2022 in part due to the uncertainty of the cost and coverage of Aduhelm. On January 10, 2022, Health and Human Services Secretary Xavier Becerra announced that he is instructing the Centers for Medicare & Medicaid Services to reassess this year’s standard premium in view of the proposed NCD and the manufacturer’s drop in price.
To read the proposed National Coverage Determination decision memorandum, visit: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305
1. Pharmacy should be aware of developing CMS-criteria for monoclonal antibodies for the treatment of Alzheimer’s disease including the proposed requirement for the patient to be enrolled in a CMS-qualifying clinical trial with a final decision by April 11, 2022.
2. The monoclonal antibody must be administered in a hospital outpatient setting to be covered under the proposed NCD.
3. Facilities which anticipate providing monoclonal antibodies for Alzheimer’s patients should consider submitting comments to CMS by February 10, 2022 on the proposed NCD.
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