A Centers for Medicare & Medicaid Services advisory panel has questioned whether there's enough evidence that amyloid PET imaging can improve health outcomes in people with early cognitive dysfunction, such as those with Alzheimer's disease.
The Medicare Evidence Development & Coverage Advisory Committee voted Jan. 30 that it had less than "intermediate confidence" the diagnostic imaging test can improve patient health outcomes. The vote, while not binding, could hurt the chances that Medicare will cover the procedure, which can cost up to $3,000 (including costs for the drug Amyvid, the PET Scan, and a physician's time).
"I just can't connect the dots between the current state of knowledge of the way the test performs and the outcome," Steve Gutman, M.D., a panelist and strategic advisor with Myraqa Inc., said, according to a DOTmed account of the meeting. "I don't think you can create a chain of evidence here that works."
The Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging have called on Medicare to cover the test, recently publishing guidelines developed by a joint task force that describes the appropriate use of brain amyloid imaging. "The [Alzheimer's] association recommends that CMS cover brain amyloid imaging according to those criteria," the Alzheimer's Association said in a statement.
The U.S. Food and Drug Administration approved the Alzheimer's imaging agent Amyvid last year. Amyvid is manufactured by Avid Radiopharmaceuticals, a subsidiary of Eli Lilly and Company.
"The overwhelmingly positive testimony presented by the medical experts around the clinical utility of beta-amyloid imaging agents reinforces that these tools should be a Medicare covered benefit for patients with cognitive impairment being evaluated for Alzheimer's Disease and other causes of cognitive decline," Wei-Li Shao, senior director, Alzheimer's Business Division, Eli Lilly and Company, said in a statement. "When making a final coverage decision, we encourage the Centers for Medicare & Medicaid Services to heavily consider the real-world medical experience presented today, and the appropriate use criteria recently released by the Society of Nuclear Medicine and Molecular Imaging and the Alzheimer's Association supporting the use of these imaging agents."