Medicare Alzheimer’s Decision Varies Evidence Mandate For Accelerated vs. Traditional Approvals
Final Medicare national coverage determination aims to set up a ‘nimble’ system to allow for broad and rapid patient access to drugs for Alzheimer’s disease following traditional approval while retaining a more restrictive approach for accelerated approvals.
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House Energy and Commerce health subcommittee easily clears a bill that would prevent another class-based national coverage determination from Medicare, but with an amendment clarifying it is for prospective decisions only, making it too late for new Alzheimer’s drugs.
CMS has long been interested in applying Medicare coverage with evidence development requirements to drugs, the former US FDA commissioner and CMS senior advisor suggests.
There is no fee to participate, and entries to the registry must be made at baseline and then every six months for up to two years.