CHICAGO, April 7, 2022
— On behalf of those impacted by Alzheimer’s disease, the Alzheimer's Association is deeply disappointed that the Centers for Medicare & Medicaid Services (CMS) has essentially ignored the needs of people living with Alzheimer's disease. Today's decision by CMS to tightly restrict coverage of Food and Drug Administration (FDA) approved Alzheimer's treatments in this class under the Accelerated Approval Pathway is wrong.
"CMS has created unnecessary barriers for individuals with Alzheimer's disease. Patients with Alzheimer's, a fatal disease, should have FDA-approved treatments covered by Medicare just as those facing other diseases do," said Harry Johns
, Alzheimer's Association chief executive officer.
Notably, CMS has said in its decision the only way for patients to access the first approved FDA treatment targeting amyloid in those living with Alzheimer's is to enroll in a clinical trial. While we note CMS has expanded where those clinical trials may take place, in reality this remains an unnecessary and never before imposed barrier to access an FDA-approved treatment.
"People living with MCI, Alzheimer's disease and other dementia deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS. They deserve the opportunity to assess if a FDA-approved treatment is right for them," said Joanne Pike
, Dr.P.H., Alzheimer’s Association president. "Drugs that treat people in the early stages of Alzheimer's could mean more time for individuals to actively participate in daily life, have sustained independence and hold on to memories longer."
The Alzheimer's Association does note some of the recommendations provided by people living with Alzheimer’s and by the Alzheimer’s Association have been incorporated. Importantly, CMS has decided to utilize a registry for future treatments granted full FDA approval. The Alzheimer's Association registry will play an important role in collecting and analyzing real-world data. This registry will monitor and report clinical and safety endpoints for patients treated with FDA-approved AD therapies, including accompanying diagnostics, to track the long-term outcomes associated with these therapies in real-world settings. Similar successful registries in heart disease and cancer have enabled researchers, clinicians, health systems and payers to track the long-term performance of therapies using a large, real-world evidence dataset.
The Alzheimer's Association is also concerned about the immediate impact this decision will have on Alzheimer's and dementia research and innovation. CMS's decision to essentially reject the Accelerated Approval Pathway for monoclonal antibodies targeting amyloid for the treatment of Alzheimer's disease is broad overreach. Accelerated approval is a pathway created by Congress and utilized by FDA to allow for earlier approval of drugs that treat serious conditions, and that fill an unmet medical need. Alzheimer's is a deadly disease with no survivors.
"The decision by CMS is a step backward for families facing Alzheimer's disease," said Maria C. Carrillo
, Ph.D., Alzheimer’s Association chief science officer. "Years of increased research funding has led to more progress and innovation than ever before, but today's decision may halt this progress as developers question if there is a pathway forward to coverage."
As the leading voluntary health organization in Alzheimer's care, support and research, the Alzheimer's Association remains ever committed, driven by the needs of our constituents. The Alzheimer's Association will continue to work with health systems, health care providers, and in communities nationwide to ensure equitable access to quality care including all current and future FDA-approved treatments and diagnostic tests needed during the treatment process for all individuals with Alzheimer's disease.
About the Alzheimer's Association
The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit alz.org or call 800.272.3900.