The Alzheimer's imaging agent Amyvid (Florbetapir F 18 Injection) is being evaluated for Medicare reimbursement.
The Centers for Medicare & Medicaid Services on Oct. 9 accepted a request from Eli Lilly, the owner of Amyvid's manufacturer Avid Radiopharmaceuticals, made in June for coverage determination. CMS announced it will accept comments on the request for coverage until Nov. 8, and expects to make a preliminary decision by July 2013, with a final decision in Oct. 2013.
The Food and Drug Administration in April approved the imaging agent as a tool to help clinicians diagnose Alzheimer's. It is used with positron emission tomography to estimate the beta-amyloid neurotic plaque density in adult patients who are being evaluated for Alzheimer's or other causes of cognitive decline.
The accumulation of amyloid plaques between nerve cells in the brain is a sign of Alzheimer's. According to the manufacturer, a negative Amyvid scan indicates few to no amyloid plaques, and reduces the likelihood that cognitive impairment is due to Alzheimer's. A positive scan indicates moderate to frequent plaques, which is present in people with Alzheimer's. Since it also is present in patients with other neurological conditions, however, Amyvid is considered to be an adjunct to other kinds of diagnostic evaluations for the disease.
"Many Americans undergo evaluations to try to determine the cause for a decline in cognitive functioning," Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, in the FDA's announcement from April. "Until now, the brain content of β-amyloid neuritic plaques could only be determined with a brain biopsy or examination of the brain at autopsy. This imaging agent is one tool to help physicians in the assessment of their patients by serving as an adjunct to other diagnostic evaluations."