Regulatory approval and insurance reimbursement: the final steps in clinical translation of amyloid brain imaging
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The introduction of [11C]PiB in 2004 and subsequent development of 18F-labelled radiopharmaceuticals for amyloid imaging transformed clinical dementia research. Advances include a greater understanding of amyloid deposition in cognitive decline and dementia, the adoption of biomarkers into the diagnostic criteria for Alzheimer’s disease (AD), and the use of amyloid imaging to help select patients for clinical trials of disease-modifying therapies. Marketing approval of these agents has made possible their use in patient care. In addition to marketing approval, however, the other key step in the translation of amyloid radiopharmaceuticals to the clinic is health insurance coverage. These two steps are typically sequential, but are otherwise often independent and have distinct challenges.
Approval to market a radiopharmaceutical is granted by a government regulatory agency. In the United States, it is the Food and Drug Administration (FDA). In Europe, the European Medicines Agency (EMA)...
KeywordsImprove Health Outcome Amyloid Imaging Improve Patient Health Coverage With Evidence Development Improve Patient Health Outcome
This work was supported by the Intramural Research Program of the NIH Clinical Center.
Conflict of interest
Peter Herscovitch declares no conflicts of interest.
This article does not contain any studies with human or animal subjects performed by any of the authors.