A first glimpse of how likely it will be that Medicare will someday cover beta amyloid PET imaging will come early next year. On January 30, 2013, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel will meet to review available evidence and hear public testimony on the use of beta amyloid PET imaging, the Centers for Medicare & Medicaid Services (CMS) announced this week.
CMS says it is interested in the clinical impact of this currently not-covered imaging test on patient health outcomes and the management of dementia and neurodegenerative disease.
In late April, the radioactive tracer Amyvid (florbetapir F18) became the first such PET brain imaging agent approved by the Food and Drug Administration (FDA) for use in marking the amyloid plaques that are the hallmarks of Alzheimer’s disease. The Eli Lilly & Company drug is expensive at around $2,000 per injection and so far few imaging center offer the test. ( RadNet became the first imaging center chain to offer it just last month.)
Other radioactive tracers with a similar function are in development, including Florbetaben by Bayer. However, only Amyvid has been approved by the FDA so far.
Alzheimer’s currently has no effective treatment, but CMS noted that “it has been asserted that identification of such beta amyloid plaque can inform the clinical management of patients with cognitive impairment who are being evaluated for possible Alzheimer's disease or other causes cognitive decline.”
Making the case that this benefit is worth the cost of the test, is likely to be an important part of the meeting.
Medicare addresses coverage of PET in section 220.6 of the National Coverage Determination (NCD) manual. Click here to view the PDF.