Alliance for Aging Research Statement on HHS Announcement Regarding CMS Reconsideration of Medicare Part B Premium Increase

WASHINGTON, Jan. 10, 2022 /PRNewswire/ -- Alliance for Aging Research President and CEO Sue Peschin, MHS, released the following statement in response to Department of Health and Human Services Secretary Xavier Becerra's announcement ordering Medicare to reconsider its FY 2022 premium increase:

"The Alliance for Aging Research supports HHS Secretary Becerra's announcement today ordering Medicare to reconsider its 2022 Part B premium increase after Biogen reduced the list price by 50 percent for Aduhelm, its FDA-approved monoclonal antibody therapy (mAB) targeting amyloid for the treatment of Alzheimer's disease. CMS previously announced the standard monthly premium for Medicare Part B enrollees would increase to $170.10 for 2022, an increase of $21.60 from $148.50 in 2021, and cited the new Alzheimer's drug as the reason behind half the increase.

Unfortunately, CMS was not transparent about how it calculated the large Part B premium increase attributed to the new Alzheimer's therapy. Additionally, we do not recall CMS previously publicly calling out the cost of care for a specific disease or chronic condition as the rationale for raising premiums. This was an unprecedented move for the agency, and highly inappropriate. We hope that Secretary Becerra mentions this in his discussions with CMS, and that the agency is explicitly ordered not to blame access to new treatments for Alzheimer's disease, or treatments for any other condition, for future premium increases.

Moreover, we hope that Secretary Becerra encourages Medicare to provide "coverage to label" for all FDA-approved mAB therapies that target amyloid for Alzheimer's disease. CMS is expected to issue its coverage decision for the entire class of these therapies this Wednesday, which will impact coverage for other drugs that have received breakthrough designation from the FDA for the treatment of Alzheimer's disease and that are currently in late-stage clinical trials. Aduhelm was approved under the FDA's accelerated approval program, which requires a phase 4 confirmatory trial to verify clinical benefit. Biogen also has an ongoing long-term extension study ongoing and a real world observational study. A CMS national coverage decision that requires "coverage with evidence development" would require additional evidence collection through clinical trials and a patient registry. These requirements would be redundant to already-occurring data collection efforts, would significantly restrict Medicare beneficiary access — especially to communities of color, as has been observed in other coverage decisions that required CED – to current and future FDA-approved mAB therapies, and unnecessarily increase competition for study recruitment and ultimately prolong evidence collection.

Secretary Becerra, we thank you for this thoughtful step forward, and we ask for your continued commitment to improve treatment access and equity for Americans living with Alzheimer's disease."

SOURCE Alliance for Aging Research