Scientific Coalition Comment on CMS’s Proposed Decision Memo on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease

February 10, 2022: We strongly support the CMS proposed decision to limit the coverage of these Alzheimer’s drugs to patients participating in clinical trials, as a way to determine if the drug is safe and effective for Medicare patients before covering the cost for millions of patients. This will provide the scientific evidence needed so that patients and family members can make informed decisions based on unbiased information.

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NCHR Comments on FDA’s Draft Guidance for Industry on Using RND to Support Regulatory Decision-Making

January 24, 2022. Although well-designed RWD and RWE studies can provide useful information about drug safety and even effectiveness, there are major shortcomings if RWD and RWE studies replace rather than supplement data from well-designed clinical trials. We therefore strongly encourage the FDA to make it clear that studies based on RWE should only be considered to provide supplemental evidence that can support regulatory decision-making for drugs and biological products.

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