WASHINGTON, January 10, 2022 /PRNewswire/ — President and CEO of the Alliance for Research on Aging Sue PechinMHS, issued the following statement in response to the Secretary of the Department of Health and Human Services by Xavier Becerra announcement ordering Medicare to reconsider its premium increase for fiscal year 2022:
“The Alliance for Research in Aging supports HHS Secretary Becerra’s announcement today directing Medicare to reconsider its 2022 Part B premium increase after Biogen cut the list price by 50% for Aduhelm, its FDA-approved monoclonal antibody (mAB) therapy targeting amyloid for the treatment of Alzheimer’s disease. Previously announced CMS 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 disease drug as the reason for half of the increase.
Unfortunately, CMS has not been transparent about how it calculated the large increase in the Part B bounty attributed to the new Alzheimer’s disease treatment. Additionally, we do not recall CMS previously publicly calling out the cost of care for a specific disease or chronic condition as justification for the premium increase. It was an unprecedented move for the agency, and highly inappropriate. We hope that Secretary Becerra will mention this in his discussions with CMS, and that the agency will be explicitly directed not to blame access to new treatments for Alzheimer’s disease, or treatments for any other condition. , for future premium increases.
Additionally, we hope that Secretary Becerra will encourage Medicare to provide “label coverage” for all FDA-approved mAB therapies that target amyloid for Alzheimer’s disease. CMS is expected to release its coverage decision for the entire class of these therapies on Wednesday, which will impact coverage of other drugs that have received FDA’s breakthrough designation for the treatment of Alzheimer’s disease. and which are currently in advanced stages of clinical trials. Aduhelm has been approved under the FDA’s Accelerated Approval Program, which requires a confirmatory Phase 4 trial to verify clinical benefit. Biogen also has an ongoing long-term extension study and a real-world observational study. A CMS national coverage decision that requires “coverage with evidence development” would require collection of additional evidence through clinical trials and a patient registry. These requirements would be redundant with data collection efforts already underway, significantly restrict access for Medicare beneficiaries – especially communities of color, as has been observed in other coverage decisions requiring DAC – to current and future FDA-approved mAB therapies, and unnecessarily increase competition for study recruitment and ultimately prolong the collection of evidence.
Secretary Becerra, we thank you for this thoughtful step forward, and we ask for your continued commitment to improving treatment access and equity for Americans living with Alzheimer’s disease. »
SOURCE Alliance for Research in Aging