Lilly Disappointed in Medicare Decision to Deny Appropriate Patient Access to Beta-Amyloid Imaging Agents, Including Amyvid

Eli Lilly and Company

is disappointed that the Centers for Medicare & Medicaid Services (CMS) has denied patient access to beta-amyloid imaging agents, such as Amyvid™ (Florbetapir F 18 Injection). This final decision is not only contrary to expert opinion and published Appropriate Use Criteria previously recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging, but contradicts the statutory authority CMS has over coverage determinations for diagnostics. Denying appropriate patient access is also in conflict with the administration's National Alzheimer's Project Act.1 CMS participated in creating this plan aimed at developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer's Disease1—yet the same agency is challenging the value of the only technology approved by the Food and Drug Administration (FDA) for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis.2 Amyvid is a beta-amyloid imaging agent for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease or other causes