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DOI: 10.1148/radiol.2453060737
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(Radiology 2007;245:645-660.)
© RSNA, 2007

Molecular Imaging Series

Regulatory and Reimbursement Challenges for Molecular Imaging1

John M. Hoffman, MD, Sanjiv S. Gambhir, MD, PhD, and Gary J. Kelloff, MD

1 From the Departments of Radiology and Neurology, University of Utah School of Medicine, 2000 Circle of Hope, Suite 2121, Salt Lake City, UT 84112-5550 (J.M.H.); Departments of Radiology and Bioengineering, Bio-X Program, Stanford University, Stanford, Calif (S.S.G.); and Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Md (G.J.K.). Received April 27, 2006; revision requested June 27; revision received October 19; final version accepted December 1. Address correspondence to J.M.H.

Molecular imaging is being hailed as the next great advance for imaging. Since molecular imaging typically involves the use of specific imaging probes that are treated like drugs, they will require regulatory approval. As with any drug, molecular imaging probes and techniques will also require thorough assessment in clinical trials to show safety and efficacy. The timeline for the regulatory approval will be long and potentially problematic because of the mounting costs of obtaining final regulatory approval. The current article is a detailed review of the regulatory and reimbursement process that will be required for molecular imaging probes and techniques to become a widespread clinical reality. The role of molecular imaging in the therapeutic drug discovery process will also be reviewed, as this is where these exciting new techniques have the potential to revolutionize the drug discovery and development process and, it is hoped, make it less costly. [18F]fluoro-2-deoxy-2-D-glucose positron emission tomography, one of the first molecular imaging techniques to be widely used, will be used as an example to illustrate the process of obtaining eventual reimbursement for widespread clinical use.

© RSNA, 2007




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