by Nancy Ryerson
, Staff Writer | October 01, 2013
The Alzheimer's disease and imaging community hit a roadblock on Friday, when the U.S. Centers for Medicare and Medicaid Services (CMS) decided to uphold its position on the PET beta-amyloid imaging for Alzheimer's disease.
CMS will cover one PET beta-amyloid scan per patient within approved clinical trials. In its decision,
the agency said that there is not enough evidence to conclude that PET beta-amyloid imaging is necessary to treat the disease.
"This is contrary to expert opinion and appropriate use criteria," Eric Dozier, senior director, Alzheimer's Business Division at Eli Lilly told DOTmed News. "What CMS is proposing, the coverage with evidence development, doesn't provide immediate access to appropriate patients, and creates additional barriers to access to an important tool."
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The Society of Nuclear Medicine and Molecular Imaging (SNMMI) also expressed disappointment over the decision, though it said in a statement that it appreciates CMS's support for the PET imaging's use in ruling out Alzheimer's disease. If a beta-amyloid scan shows no plaque, then the patient does not have Alzheimer's disease; if the scan shows plaque, it can suggest one of several neuro-degenerative disease, or normal aging.
"Although Alzheimer's disease is the leading cause of memory loss, several other factors — such as other neurodegenerative diseases, strokes, thyroid problems or medications — can cause similar symptoms," the statement said. "A test that can rule out Alzheimer's disease can result in patients being taken off powerful medications that can be costly and are not indicated for their condition. That is a positive outcome."
Lilly and SNMMI both plan to immediately connect with stakeholders to determine next steps.