Council of State Bioscience Association Submits
Comments to CMS
BioNJ joined with 45 members of the Council of State Bioscience Association (CSBA) to deliver an unprecedented response to the Centers for Medicare & Medicaid Services (CMS) regarding the recent National Coverage Analysis (NCA) for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease.
The letter conveyed CSBA’s concern that the Proposed National Coverage Determination (NCD) would set a dangerous precedent, restricting access to a promising class of new amyloid-focused therapies. In addition to the impact on Americans struggling with AD, it would also have far-reaching implications for a variety of Patient populations living with unmet medical needs – Patients who stand to benefit from therapies approved for difficult-to-treat diseases, notably those approved by the Food and Drug Administration (FDA) under the Accelerated Approval pathway.
CSBA also voiced concern with the proposal which limits coverage only to Patients enrolled in government-approved Randomized Control Trials (RCTs) as the vast majority of individuals suffering from AD will have no meaningful access to an approved medicine simply because of where they live and where they go for care.
CSBA shared that CMS should be encouraging the development of new and innovative treatments for conditions like AD – not adopting restrictions on coverage that threaten to stall the advancement of an entire class of therapies for a degenerative condition that has no viable treatment option.