Sept. 27, 2013
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) 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.
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 (FDA) 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. 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.
"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," said
, senior director, Alzheimer's Business Division, Eli Lilly and Company. "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."
About Alzheimer's Disease
Alzheimer's Disease, a fatal illness, is the most common form of dementia, accounting for 60 to 80 percent of dementia cases.
It continues to be one of the most significant health challenges facing
the United States
, with an estimated 5.2 million Americans already suffering from the disease—5.0 million of whom are aged 65 and over.
Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging.
In fact, it is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not exhibit Alzheimer's Disease pathology upon autopsy.
If it is determined that Alzheimer's Disease is not the cause of a patient's cognitive impairment, their doctor can avoid or discontinue unnecessary or potentially harmful treatments and investigate other possible causes.
, 8, 9
Amyvid is a radioactive diagnostic agent that is injected into the bloodstream, where it crosses the blood-brain barrier and selectively binds to amyloid plaques. The fluorine 18 (F 18) isotope produces a positron signal, which is detected by a PET scanner. Doctors who read Amyvid PET scans should complete a comprehensive training program available through live events or online at AmyvidTraining.com.
For more information about Amyvid, please see Prescribing Information at
INDICATIONS AND USAGE
Amyvid is approved for use in adults with thinking or memory problems who are being assessed for Alzheimer's Disease (AD) or other causes of these symptoms. Amyvid is used by doctors in combination with other tests.
Amyvid is used with a positron emission tomography (PET) scanner to show whether high levels of plaques, which are a buildup of a protein called beta-amyloid, are in the brain.