Steven D. Pearson, Daniel A. Ollendorf, Jennifer A. Colby; the ICER Alzheimer’s Diagnostics Policy Development Group

Outside of their uses in drug development and clinical research trials, the current clinical value of performing any type of formal biomarker testing for the diagnosis or exclusion of Alzheimer’s disease (AD) is controversial, and most biomarker tests for AD are not covered by public or private insurers. This situation raises the issue of how insurers determine whether there is “adequate” evidence to justify a positive coverage determination in this area. This article, a focused condensation of a larger white paper, is the product of an initiative led by the Institute for Clinical and Economic Review to convene a multiple-stakeholder AD Diagnostics Policy Development Group composed of patient advocates, clinicians, clinical researchers, manufacturers, and insurers. The larger white paper was the basis for the evidence review presented to the Medicare Evidence Development and Coverage Advisory Committee meeting on January 30, 2013, as part of its deliberations on positron emission tomography–amyloid imaging. Herein we focus on the description of the core elements of what insurers will be looking for in evidence on all potential diagnostic tests for AD. Corresponding research recommendations are also included, framed to serve as a guide for future AD diagnostics research.