Newswise — Clumps of protein called amyloid-beta fill the senile plaques found in the brains of people with Alzheimer’s disease. In April 2012, the Food and Drug Administration (FDA) approved the first amyloid-beta imaging agent, Eli Lilly and Company’s Amyvid, as a tool to help clinicians diagnose the disease. Plaques that bind Amyvid can be seen on positron emission tomography (PET) scans, however, these are unlikely to see widespread clinical use unless insurance covers them. Clinics charge private patients several thousand dollars for the procedure. The Centers for Medicare and Medicaid Services (CMS), a government agency that administers Medicare and Medicaid, decides which services those programs reimburse. CMS currently excludes coverage nationwide for all new PET radiotracers, including Amyvid. Private payers tend to follow CMS’ lead. As reported by Alzforum, the Medical Imaging and Technology Alliance (MITA), a Washington, D.C.-based industry association, petitioned CMS in July 2012 to remove this nationwide exclusion and allow local Medicare contractors to make their own coverage decisions. CMS promised to re-analyze this issue, with a decision expected in 2013.
MITA, which represents the interests of more than 60 companies that manufacture medical imaging equipment and radiopharmaceuticals, contends that removing the exclusion would make PET radiotracers equivalent to other drug classes. Tracers for magnetic resonance imaging or computed tomography, for example, are eligible for coverage by local Medicare contractors as soon as the FDA approves them. The MITA petition is co-signed by professional imaging associations, including the American College of Radiology, the Council on Radionuclides and Radiopharmaceuticals, the Society of Nuclear Medicine and Molecular Imaging, and the World Molecular Imaging Society.
Public comments on the petition from nuclear medicine physicians and Alzheimer’s advocacy groups generally support the proposal, although some note that clear guidelines will be needed to avoid misuse of the amyloid imaging technology. Several insurance groups oppose the petition, pointing to a lack of evidence for whether amyloid scans will make a difference in patient care. Amyvid is only the first of many radiotracers expected to earn approval for clinical amyloid imaging in the near future.
Two Alzforum stories “ Who Will Pay for New Amyloid Scans? The Lobbying Has Begun and “Scan and Tell? Amyloid Imaging Confronts Disclosure Dilemma” lay out the petition and the thorny ethical questions around scanning for plaques in people who have no or only mild cognitive symptoms.
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