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Published January 10, 2022
WASHINGTON, January 10, 2022 – 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.”
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application to vastly improve the universal human experience of aging and health. The Alliance believes advances in research help people live longer, happier, more productive lives and reduce healthcare costs over the long term. For more than 30 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the National Institutes of Health and Food and Drug Administration; built influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers. For more information, visit www.agingresearch.org