Three radioactive tracers (florbetapir fluorine 18, florbetaben fluorine 18, flutemetamol fluorine 18) that bind to β-amyloid (Aβ) and can be detected in vivo with positron emission tomography (PET) have been developed. This technology is being evaluated to detect Aβ neuritic plaque density in adults with cognitive impairment who are being evaluated for Alzheimer disease (AD).
For individuals who have suspected AD who receive Aβ imaging with PET, the evidence includes pivotal studies for 3 agents. Relevant outcomes are test accuracy, other test performance measures, symptoms, and functional outcomes. The pivotal trials showed moderately high sensitivity and specificity compared with histopathology of Aβ plaque in patients with possible or probable AD, and several studies have reported a change in diagnosis and a change in management after testing. However, histopathologic diagnosis of AD depends on several biomarkers, and there is currently no evidence that Aβ imaging leads to an improvement in the differential diagnosis of AD and non-AD dementias over current clinical practice. The pivotal phase 3 trial with florbetapir had a number of limitations including small sample size, use of a majority rating of 3 physicians, and very few patients in the mildly impaired category. The pivotal florbetaben and flutemetamol studies did not include patients with mild cognitive impairment (MCI). The sensitivity and specificity of Aβ imaging with PET have not yet been adequately determined in an appropriate population, including a larger number of patients with MCI. Also, direct or indirect evidence of improved health outcomes with this technology is lacking. Aβ imaging with PET is not likely to help confirm AD in patients who present with cognitive impairment. It may have a role in ruling out AD in patients with MCI, but the diagnostic accuracy of testing in patients with MCI is too uncertain to determine whether testing is likely to impact management and/or lead to improved outcomes. The evidence is insufficient to determine the effects of the technology on health outcomes.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Beta-amyloid imaging with positron emission tomography is investigational.
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78811, 78814, A9586, A9599, Q9982, Q9983, C030YZZ
