I'm an independent healthcare analyst with more than 24 years of experience analyzing healthcare and pharmaceuticals.
A Centers for Medicare and Medicaid decision memorandum issued last month lifts restrictions on coverage of Alzheimer’s disease diagnostics that measure beta amyloid plaque in the brain. Excessive levels of plaque are considered an indicator of the presence of Alzheimer’s disease. Facilitating reimbursement of diagnostic tests is critical in light of recent approvals of drugs intended to reduce amyloid plaque.
Thanks to several products launched a decade ago there are diagnostic tools to evaluate beta amyloid density. In 2012, florbetapirF—marketed as Amyvid—became the first diagnostic agent to be approved by the Food and Drug Administration for positron emission tomography of the brain to assess plaque build-up.
It makes sense that CMS changed its policy given the recent approvals of drugs which are designed to remove beta amyloid plaque: Aduhelm and. Immediately following Leqembi’s regular approval by the FDA in July, CMS announced it would cover much of the cost forIn order to benefit from these biologic therapeutics patients must have beta amyloid plaque present in their brains.
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