Drug maker Eli Lilly and Co. (LLY) said Monday it was disappointed that the Centers for Medicare & Medicaid Services or CMS has denied patient access to its Amyvid or Florbetapir F 18 Injection, used as beta-amyloid imaging agent for patients being assessed for Alzheimer's Disease.
The company added that as it continued to review the final decision memo by CMS, it will evaluate all available options to ensure patients as well as physicians can gain access to the diagnostic tool as soon as possible.
Eli Lilly noted that the final decision by CMS was not only contrary to expert opinion and published "appropriate use criteria" previously recommended by the Alzheimer's Association as well as the Society of Nuclear Medicine and Molecular Imaging, but it also contradicted the statutory authority CMS has over coverage determinations for diagnostics.
In a statement, Eli Lilly said, "Denying appropriate patient access is also in conflict with the administration's National Alzheimer's Project Act. CMS participated in creating this plan aimed at developing new and innovative ways to diagnose, support and treat patients suffering from Alzheimer's Disease - yet the same agency is challenging the value of the only technology approved by the Food and Drug Administration for estimating beta-amyloid neuritic plaque density in the living brain, which can aid in helping doctors make a more informed diagnosis."
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 of these symptoms. It is used by doctors in combination with other tests.
Amyvid, a radioactive diagnostic agent, is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques. The fluorine 18 or F 18 isotope produces a positron signal, which is detected by a positron emission tomography or PET scanner.
A positive Amyvid scan does not diagnose Alzheimer's Disease or other thinking or memory disorders. The drug is also not approved to predict the development of dementia or other brain conditions in the future or for monitoring the effectiveness of treatments.
In Monday's regular trading session, LLY is trading at $50.57, up $0.07 or 0.14 percent on a volume of 91,661 shares.
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