In comments submitted by AHIP, a national association whose members provide healthcare coverage, to the Centers for Medicare & Medicaid Services (CMS) regarding the Proposed National Coverage Determination (NCD) for Monoclonal Antibodies (mAbs) Directed Against Amyloid for the Treatment of Alzheimer’s Disease, AHIP reaffirmed its commitment saying that Alzheimer’s disease takes a heavy toll on patients and their families.
The comments say that AHIP strongly supports CMS’ proposed approach to coverage of these treatments in the context of clinical trials:
“We commend CMS for its comprehensive, thoughtful and objective analysis of the clinical evidence, benefits, and potential side effects of this class of therapies. We agree with CMS’ conclusion that ‘no trial has been able to demonstrate any meaningful improvement in patient health outcomes,’ noting: ‘Due to the lack of a clear clinical benefit and the frequency of adverse events like [amyloid related imaging abnormalities] ARIA, the evidence does not support that the benefits outweigh the harms for mAbs directed against amyloid for the treatment of AD.’”
This is the right approach for patients:
“The proposed NCD is the right approach for patients. It would provide Medicare patients consistent and national access for this class of products and related services. And it would appropriately emphasize the need for sufficient clinical evidence to support future determinations of whether these drugs are both reasonable and necessary for the right populations within the program.”
It is also important that CMS would require that clinical trials for these treatments reflect the diversity of the population with Alzheimer’s Disease.
Many stakeholders agree with CMS’ approach:
“CMS and many clinicians, health systems, and other stakeholders recognize that Medicare coverage should apply only when there is clear evidence of clinical benefit to patients that outweighs the risk of significant harm, and they have appropriately concluded there is not sufficient evidence on safety and effectiveness to meet this standard.”