INDIANAPOLIS, July 3, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a draft decision proposing Coverage with Evidence Development for the use of beta-amyloid positron emission tomography (PET) imaging agents. Beta-amyloid imaging agents are used to evaluate patients with cognitive impairment for Alzheimer's Disease and other causes of cognitive decline. 1
An Amyvid™ (Florbetapir F 18 Injection) beta-amyloid scan is for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease or other causes of these symptoms. Amyvid is used by doctors in combination with other tests. A positive Amyvid scan does not diagnose Alzheimer's Disease or other thinking or memory disorders. Amyvid is not approved to predict the development of dementia or other brain conditions in the future or for monitoring the effectiveness of treatments. Amyvid for intravenous use is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18 .2
"CMS appears to be challenging the value of an adjunctive tool that can assist physicians in making a more informed diagnosis for patients with cognitive impairment. Restricting coverage could hinder a timely and accurate diagnosis, which is in conflict with the advice of Alzheimer's Disease experts and with the administration's National Alzheimer's Project Act," said Daniel Skovronsky, M.D., Ph.D., president and CEO, Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, and vice president, Tailored Therapeutics at Eli Lilly and Company. "In addition, it may stifle future innovation aimed at improving diagnosis."
A decision for Coverage with Evidence Development proposes that there are still evidentiary gaps necessary to reconcile prior to reevaluating coverage. CMS would require additional trial(s) to address these gaps, and only those patients taking part in the trials would be eligible for coverage. 3 Once those studies are complete, CMS can conduct another national analysis and render a decision on coverage."Lilly remains steadfast in our request for Medicare coverage of beta-amyloid imaging agents for the appropriate patient population without Coverage with Evidence Development, as recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging," said Wei-Li Shao, senior director, Alzheimer's Business Division, Eli Lilly and Company. A task force of experts organized by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging has developed the Appropriate Use Criteria, which outline the appropriate and inappropriate use of amyloid PET imaging. 4 The decision is currently in draft form and is subject to change before the final decision is expected in October. For now, there is a 30-day comment period in which interested parties can post their reactions to the decision at http://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-closed-index.aspx. Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. 5,6 In fact, it is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not exhibit Alzheimer's Disease pathology upon autopsy. 7,8 If determined through clinical assessment and scan results that Alzheimer's Disease is not the cause of a patient's cognitive impairment, their physician can avoid or discontinue unnecessary or potentially harmful treatments and investigate other possible causes. 9,10,11 About Amyvid 2 Amyvid is an FDA-approved radioactive diagnostic agent that is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques. The fluorine 18 (F 18) isotope produces a positron signal, which is detected by a PET scanner. Physicians who read Amyvid PET scans should complete a comprehensive training program available through live events or online at AmyvidTraining.com. For more information about Amyvid, please see the Full Prescribing Information at http://pi.lilly.com/us/amyvid-uspi.pdf. INDICATIONS AND USAGE: 2 Amyvid is approved for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease (AD) or other causes of these symptoms. Amyvid is used by doctors in combination with other tests. Amyvid is used with a positron emission tomography (PET) scanner to show whether high levels of plaques, which are a buildup of a protein called beta-amyloid, are in the brain.