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Lilly Supports The Medical Community's Testimony On The Clinical Utility Of Beta-Amyloid Imaging Agents, Such As Amyvid™ (Florbetapir F 18 Injection), During CMS Public Hearing

INDIANAPOLIS, Jan. 30, 2013 /PRNewswire/ -- Leading medical experts in the fields of imaging, neurology and dementia came together today to present evidence supporting the clinical utility of beta-amyloid imaging agents, such as Amyvid™ (Florbetapir F 18 Injection), during a public hearing held by the Centers for Medicare & Medicaid Services (CMS), known as a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting.

The CMS panel voted "low to intermediate confidence" in response to whether there is adequate evidence available to determine whether or not positron emission tomography (PET) imaging of brain beta-amyloid changes health outcomes (improved, equivalent or worsened) in patients who display early symptoms or signs of cognitive dysfunction. Additionally, the panel voted "high confidence" that these conclusions are generalizable to the Medicare beneficiary population. The MEDCAC vote may impact future Medicare coverage decisions for beta-amyloid imaging agents.

Amyvid is indicated for PET imaging of the brain to estimate beta-amyloid plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline. Amyvid is an adjunct to other diagnostic evaluations. Amyvid for intravenous use is a radioactive diagnostic agent that is supplied in 10 mL, 30 mL, or 50 mL multidose vials containing 500-1900 MBq/mL Florbetapir F 18. 1

"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," said Wei-Li Shao, senior director, Alzheimer's Business Division, Eli Lilly and Company. "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."

The new guidelines state that amyloid imaging could potentially be helpful in the diagnosis of people with cognitive impairment when considered along with other clinical information, and when performed according to standardized protocols by trained staff. The guidelines also indicate that, although published data is extremely limited, amyloid PET is likely to contribute to better patient care under specific circumstances. 2

The panel voted on two questions, giving a score from one to five – one being low confidence, five being high confidence. The questions focused on whether there is adequate evidence to determine if PET imaging of brain beta-amyloid changes health outcomes in patients who display early symptoms or signs of cognitive dysfunction, and if the evidence can be generalized to the Medicare beneficiary population.

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