Medical Research: What is the background for this study?
Dr. Cohen: Florbetapir 18F was the first radioactive diagnostic agent approved by the US Food and Drug Administration for positron emission tomography imaging of the brain to evaluate amyloid â neuritic plaque density.
Medical Research: What are the main findings?
Dr. Cohen: Medicare has restricted coverage of florbetapir in the US, whereas conspicuously the UK NHS decided to reimburse the radiopharmaceutical. Note, the British NHS is generally more restrictive with regard to coverage of new technologies than the Centers for Medicare and Medicaid Services. Historically Medicare has rejected coverage of 25% of diagnostics approved by the FDA, but covers all FDA approved drugs administered in the physicians office. Furthermore, Medicare has subjected labeled use of diagnostics, including a half-dozen Alzheimer’s diagnostics, to its coverage with evidence development program while not subjecting any labeled uses of drugs to coverage with evidence development. In sum, diagnostics are subject to a level of scrutiny by Medicare that is rarely given Medicare Part B drugs (physician-administered).
Medical Research: What should clinicians and patients take away from your report?
Dr. Cohen: From a clinical and policymaker perspective, Medicare’s inconsistency can impede patient access to important new technologies, such as florbetapir. Medicare should be more consistent in terms of the level of scrutiny given diagnostics and drugs. In addition, measurement of benefits of diagnostics such as florbetapir should be broader than patient outcomes. In the absence of Alzheimer’s treatments that confer significant benefits, florbetapir’s impact will be measured with respect to its ability to rule out Alzheimer’s, which in turn will influence a patient’s treatment pathways.
Medical Research: What recommendations do you have for future research as a result of this study?
Response: A prudent approach would be for the Centers of Medicare and Medicaid Services to provide all Medicare beneficiaries with access to florbetapir.
Joshua P. Cohen Ph.D, & Research Associate Professor (2015). Medicare’s Inconsistent Drug Coverage Policies Can Impede Access To New Technologies