Despite the refusal of the Centers for Medicare & Medicaid Services to provide full coverage of amyloid PET imaging, radiopharmaceutical companies continue research efforts in the field of Alzheimer's disease and other disorders like Parkinson's disease, according to a DOTmed News article.
Last summer, CMS ruled that it will cover one amyloid PET scan per patient in clinical trials that address the effectiveness of these scans, a decision that was met with some dismay by companies like Eli Lilly (the manufacturer of Amyvid, an approved tracer for amyloid imaging) and advocacy organizations like the Alzheimer's Association.
While the CMS decision hasn't swayed Eli Lilly from pursuing research in this area, "we acknowledge that such uncertainty in the reimbursement process creates a strong disincentive for future investments in research and development," Stefanie Prodouz, a spokesperson for Lilly Bio-Medicines, told DOTmed News. "To foster future innovation, manufacturers need predictable pathways to coverage."
Despite the reimbursement uncertainty, other companies are moving ahead in the area of amyloid imaging, as well. In March, the U.S. Food and Drug Administration approved another amyloid PET agent, Neuraceq. A third PET agent, GE Healthcare's Vizamyl, was approved last October.
A major issue with getting reimbursement for amyloid imaging is that CMS wants to see whether there is change in the clinical management or benefit to a patient after receiving a scan. According to Dean Hartley, director of science initiatives at the Alzheimer's Association, that is particularly the case since there is no treatment available that can change the course of Alzheimer's disease.
"When there's an effective treatment, imaging will become critical to the assessment of an individual," Hartley told DOTmed News. "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."
GE Healthcare is moving ahead with plans to get Vizamyl on the market, having recently announced that it will make the diagnostic agent available to imaging centers in East Rutherford, New Jersey, Woburn, Massachusetts, Beltsville, Maryland, East Lansing, Michigan, Dallas, Phoenix and Colton, California.
A fourth amyloid imaging agent is being developed by Navidea Biopharmaceuticals and is currently undergoing clinical trials.