by
Lisa Chamoff, Contributing Reporter | June 19, 2014
From the June 2014 issue of HealthCare Business News magazine
“CMS wants to see what is the change in clinical management or the benefit to the patient after receiving an amyloid scan,” Hartley says. “Part of their concern is that there are currently no treatments to change the course of the disease, therefore they want evidence to show the benefit of the scan.”
Imaging can determine whether a patient might have Alzheimer’s disease or other cognitive issues, such as frontotemporal dementia, which can be clinically difficult to distinguish from Alzheimer’s, but usually does not include buildup of beta-amyloid plaque. There’s no current treatment for frontotemporal dementia, and FDA-approved drugs only seem to treat the symptoms of Alzheimer’s.
Hartley says there are a number of Alzheimer’s prevention trials underway, including ones that are testing a couple of different therapies to see if they can change the biomarkers early on. Imaging is used to indicate whether the beta-amyloid plaque has lessened.
“When there’s an effective treatment, imaging will become critical to the assessment of an individual,” Hartley says. “It’s just because we don’t have treatments we can’t see the benefit of these particular diagnostic tools. I think all of these, once we find some treatments, will show the benefit of these non-invasive tools. We are very excited and optimistic about where this will go with early diagnosis and treatment.”
GE Healthcare is also moving forward with putting Vizamyl on the market. Ben Newton, the company’s director of PET Neurology, says that use of the scans is low, but not just because of the lack of reimbursement.
“A lot of the demand for diagnostics in this area is going to come from the launch of therapies on the market,” Newton says.
Newton compares PET amyloid imaging to one of GE Healthcare’s other products, DaTscan, or Ioflupane I123, which is used with SPECT brain imaging to detect a striatal dopaminergic deficit, which is associated
with several conditions, including Parkinsonian syndromes. In patients with suspected Parkinsonian syndromes, the scans can help differentiate them from essential tremor, or ET. In Europe, DaTSCAN, the name the drug is marketed under there, is also used to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer’s disease.
When DaTSCAN launched in Europe, there was no utility data and no reimbursement, and it’s now one of the key molecular imaging agents used frequently in the diagnosis of Parkinson’s, Newton says.
“We see PET amyloid imaging in the same kind of way,” Newton says. “We’re in the early stage of acceptance.”
