On January 30, 2013, an expert panel, convened by the Centers for Medicare and Medicaid Services (CMS), voted they had only low to intermediate confidence that there was “adequate evidence to determine whether or not PET imaging of brain beta-amyloid changes health outcomes” in people who show early signs of cognitive issues. CMS is considering whether to cover the relatively expensive test that has been estimated to cost approximately $3,000 to $6,000 per scan.
One outcome of this recommendation by this Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) panel could be that CMS will decide not to cover payments for these scans. Without coverage, there’s a potential for disparity of care and disruption to the lives of many individuals, families, and caregivers living with Alzheimer’s disease or other cognitive dysfunctions.
BrightFocus is disappointed with the panel’s recommendation, since an early, definitive diagnosis of Alzheimer’s could help patients better cope with their disease by eliminating the anxiety of the unknown, providing time for planning and informed decisions, and allowing access to disability and other support services. This new scan would be a welcome addition to a clinician’s diagnosis “toolbox.”
The beta-amyloid positron emission tomography (PET) scan under discussion by the panel uses Eli Lilly & Company’s Food and Drug Administration (FDA)-approved drug AmyvidTM, or florbetapir, to detect the presence of amyloid brain plaques, a hallmark of Alzheimer’s disease. It was not discussed whether potential CMS coverage would extend to future FDA-approved drugs that also detect beta-amyloid or other proteins associated with cognitive decline, that might be paired with the same imaging technique.
Some experts who presented at the MEDCAC meeting stressed that the additional clinical information provided by this scan would help doctors make better decisions on treatment plans in cases where the current, standard series of tests (including blood and cerebrospinal fluid analysis, brain structural scans, and psychological assessment) do not offer a definitive diagnosis. Speaker Norman L. Foster, M.D., Chief of the Division of Cognitive Neurology, and Director of the Center for Alzheimer’s Care, Imaging, and Research in the Department of Neurology at the University of Utah, stated that this scan is not a “diagnostic test,” but “one piece of important information that doctors will use for diagnostics.”
One concern of the panel was the potential harm that could result from a false positive test. Previous reports suggested that thirty percent of people who have detectable beta-amyloid brain plaques never go on to develop cognitive decline. Therefore, a misdiagnosis of Alzheimer’s disease could lead to patients being started on drugs that provide limited benefit, depression, discrimination, loss of employment, or difficulty in obtaining long-term care insurance.
However, a number of the speakers assured the panel that the chance of false positives would be reduced, provided doctors adhere to the official instructions for use by the FDA. Mark Mintun, M.D., Chief Medical Officer of Avid Radiopharmaceuticals, a wholly owned subsidiary of Eli Lilly & Company that developed Amyvid, said the FDA-approved instructions state that only “adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline” should be given the test.
These concerns could be outweighed by the benefits of a true negative test, including: further examination for another, perhaps more treatable, cause of dementia; a potential reduction of the number of patients started on drug; and peace of mind for patients and families.
Another concern of the panel was that they needed assurance there would be adequate training of professionals who would be reading these specialized PET scans, since they were sometimes difficult to interpret.
William Thies, Ph.D., Chief Medical and Scientific Officer of the Alzheimer’s Association (AA), and representative speaker for the Amyloid Imaging Taskforce and Society of Nuclear Medicine and Molecular Imaging (SNMMI), explained that one important part of the “Quality of Education Initiatives” of the SNMMI/AA Appropriate Use Criteria for Amyloid PET was that they would help to “develop procedure guideline” and “education of imaging professionals,” including web-based training and live continuing education.
In addition, Rathan Subramaniam, M.D., Ph.D., M.P.H., Associate Professor of Radiology and Nuclear Medicine at Johns Hopkins University, and Vice Chair of the Commission on Nuclear Medicine and Molecular Imaging of the American College of Radiology, said that a committee will soon release their guidelines for appropriate use, training, and continuing medical education for beta-amyloid PET imaging to reduce the potential for variation of interpretation by imaging professionals.
The MEDCAC panel’s last recommendation was that to close what they consider to be gaps in the scientific evidence, there would need to be randomized, controlled clinical trials to determine the specific effect(s) of beta-amyloid PET imaging on patients’ quality of life and the actual change in physicians’ diagnoses and treatment regimens.
The final decision on coverage by CMS is expected within the next few months.
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