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Latest FDA approval sparks CMS launch of Alzheimer’s registry but questions remain
July 7, 2023 (WASHINGTON, D.C.) The Partnership to Fight Chronic Disease (PFCD) released the following statement in response to the U.S. Food and Drug Administration (FDA) decision to grant traditional approval to Leqembi and the launch of a Centers for Medicare and Medicaid Services (CMS) registry related to the current National Coverage Determination (NCD) requiring Coverage with Evidence Development (CED) for an entire class of Alzheimer’s disease treatments.
“The Partnership to Fight Chronic Disease applauds the FDA’s traditional approval of Leqembi for people living with early-stage Alzheimer’s disease. As part of a class of the first ever treatments that interrupt the progressive cognitive decline associated with Alzheimer’s disease, this approval marks a significant milestone in the fight against this devastating illness.
“PFCD also recognizes the accompanying announcement from CMS providing additional details on the clinical registry and study that CMS is requiring to cover Leqembi under Medicare. Many questions remain around the implementation of the CMS portal, the potential burden involved with its use as a condition of coverage, and how long CMS will leave these requirements in place.
“However, we reaffirm and stand alongside patient advocates, providers, and federal and state policymakers who continue to assert that CMS must reconsider its National Coverage Determination requiring Coverage with Evidence Development and remove the CED requirement altogether for FDA-approved treatments for Alzheimer’s disease. We remain highly concerned by the dangerous precedent being set by CMS in requiring CED for FDA-approved therapeutics and the agency’s continued advancement of policies that suggest therapeutics approved by the FDA under the accelerated approval pathway are not “fully” approved or otherwise less deserving of coverage by Medicare, Medicaid, or other federal programs.”
To learn more about these access issues and the long road to Alzheimer’s treatment via the patient registry process, please visit: