Promise of Alzheimer’s PET Imaging Hinges on Reimbursement

Alzheimer’s Disease is now the sixth leading cause of death in the United States and one in three seniors dies with some degree of dementia, announced the Alzheimer’s Association this week. Yet nearly a year after the U.S. Food and Drug Administration (FDA) approved the first brain imaging test to diagnose Alzheimer’s, the test remains uncommon outside of research trials, says Judith Rose, MD, director of PET/CT and nuclear medicine for RadNet. RadNet’s Shine a Light on Dementia program is the nation’s largest network of outpatient imaging centers that offers brain amyloid imaging with PET as an Alzheimer’s test. Since performing the first such scan July 30, 2012, RadNet has increased the number or radiologists trained to read the test to 30 and the number of sites offering the test from 10 to 23. In total, RadNet has performed 75 brain amyloid imaging scans that are non-research cases. This is a big number considering that even experts at leading academic institutions may only have been the primary reader on a handful of these tests, but small when considering how many patients nationwide are affected by dementia. Rose says the amount of experience they’ve been able to amass, their database of past images, and the size of their network is getting them notice in the research community and offers to participate in studies beyond just Alzheimer’s research. “No one else can say in aggregate that they’ve done 75 cases,” she notes. “We have the largest national experience and the biggest network, so if you are trying to start a trial on a drug, you don’t just have to stay in Baltimore. You can include patients in any geographical territory that RadNet is in.” However, what she really would like to see is a national coverage decision that could make the test available to Medicare beneficiaries. Studies show that as many as one in five people diagnosed with Alzheimer’s don’t actually have the disease, and there is a great deal of wasted treatment and loss of quality of life occurring that could be avoided if more patients had access to brain amyloid imaging with PET, Rose believes. “What you really want and what we are not making very fast progress on is some national coverage decision by Medicare,” she says. Even with Eli Lilly — the maker of the first FDA-approved radiopharmaceutical for brain amyloid imaging (Amyvid) — giving away a select number of Amyvid doses through a voucher program, the number of patients who are willing and able to cover the cost of the technical and professional components of the test is limited, Rose says. “We have a lot of interest, but few patients are willing to pay for it,” she notes. There are some hopeful signs, however. On January 28, experts from the Alzheimer’s Association and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) jointly published the first appropriate use criteria for brain amyloid imaging with PET. Use criteria are a key step any coverage process, Rose notes. Then, two days later, the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) met to consider whether Medicare should cover brain amyloid imaging with PET. The voting MEDCAC members found that more research would be needed to allow coverage. They also noted the importance of the issue going forward. In her concluding remarks, Rita Redberg, MD, a UCSF cardiologist and the MEDCAC meeting chairperson said: “As everyone here agrees, Alzheimer's is certainly a growing problem and a really important problem that has a tremendous impact on our patients.”