Alzheimer’s Community Prepares To Challenge CMS Amyvid Proposal
This article was originally published in The Pink Sheet Daily
Alzheimer’s community stakeholders are planning a unified response to a CMS Medicare coverage proposal that would, in their view, disastrously constrain use of PET imaging, and imaging agents like Lilly’s Amyvid, in the diagnosis and management of Alzheimer’s patients.
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The final coverage decision for Lilly’s Amyvid sticks with the proposal to limit payment to use in clinical trials. That is a setback for Lilly, but reinforces the Medicare agency’s commitment to the Coverage with Evidence Development pathway.
Agency’s final national coverage determination for beta amyloid positron emission tomography in diagnosing dementia confirms stance the diagnostic will be covered only in trial setting for Medicare, but may offer a little more flexibility in trial design.
“Improvement in health outcomes” standard would interpret “the statute to require both diagnosis and treatment,” Lilly says about CMS’ recent evaluation of beta-amyloid positron emission tomography in dementia and neurodegenerative disease.