Lilly “disappointed” with CMS’ decision on Amyvid

Eli Lilly & Company is "disappointed" with the decision made by the US Centers for Medicare & Medicaid Services (CMS) to deny patient access to beta-amyloid imaging agents, such as Amyvid. Amyvid (Florbetapir F 18 Injection) 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 of these symptoms.

There is controversy over this decision as it goes against published Appropriate Use Criteria previously recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging, and it also contradicts the statutory authority CMS has over coverage determinations for diagnostics.

"Coverage with Evidence Development as proposed by CMS does not provide patients appropriate access to these amyloid imaging brain scans. Instead, it creates additional complexity for the broader community in determining the best path forward for patients. As we continue to review the final decision memo, we will be evaluating all available options to ensure patients and physicians can gain access to this innovative diagnostic tool as soon as possible."

Eric Dozier, senior director, Alzheimer's Business Division, Eli Lilly and Company.

Amyvid is the only FDA-approved technology for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis.

Alzheimer's Disease is the most common form of dementia and continues to be one of the most significant health challenges facing the US and the rest of the world.