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Lilly Disappointed in Draft Medicare Coverage Decision for Beta-Amyloid Imaging Agents
Date:7/7/2013

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 ther
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