Could Alzheimer’s Drugs Avoid Medicare Coverage Restrictions If They Are Covered By Part D?
Biogen exec suggests subcutaneous injectable forms of Alzheimer’s treatments subject to Medicare’s draft national coverage determination might find better patient access if they are covered by the Part D program, but that path comes with its own set of risks.
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Proposed Medicare national coverage policy would delay access to Alzheimer’s drugs for too long and the government should instead cover the drugs under specific conditions until research already underway comes in, Global Alzheimer’s Platform Foundation president John Dwyer argues.
Results from the US Food and Drug Administration’s RCT DUPLICATE demonstration are in. The findings both legitimize certain real-world evidence studies and also highlight the challenges involved in using RWE to replicate randomized clinical trials.
By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.