As New Products Meant to Slow the Advance of Alzheimer’s Disease Approach FDA Approval, Finance Chairman Asks Health Agencies for More Clarity on Medicare’s Plans for Data Collection, Patient Registration
Washington, D.C. – Senate Finance Committee Chair Ron Wyden, D-Ore., asked the Biden Administration for information about the Centers for Medicare & Medicaid Services’ (CMS) plans to help Americans access new Alzheimer’s medications that are coming to market.
“I write today to ask CMS to provide prompt, clear, and publicly available information about how Medicare providers and patients can participate in a registry or submit data under the agency’s coverage with evidence development (CED) policy that allows Medicare to cover new Alzheimer’s medicines,” Wyden wrote. “I support the CED policy to gather more information about how these drugs work in the Medicare population, yet feel strongly the agency must use every tool at its disposal to support creation of the approved methods providers and their patients can use in providing this information should one of these medications gain full FDA approval.”
In the letter, sent to Health and Human Services (HHS) Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure, Wyden asked CMS to disclose a variety of information about its plans to release more details about how it will help Medicare beneficiaries and health providers understand how to access new Alzheimer’s therapies that may receive full approval from the Food and Drug Administration (FDA).
Wyden has previously raised concerns with the accelerated approval process as it relates to new therapies for Alzheimer’s disease, particularly in light of the potential for higher Medicare premiums to finance the high prices the manufacturer’s set for many of these therapies.
The full letter can be found here.
A web version of this release is here.
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