Advertisement

Clinical and Translational Imaging

, Volume 3, Issue 1, pp 75–77 | Cite as

Regulatory approval and insurance reimbursement: the final steps in clinical translation of amyloid brain imaging

  • Peter HerscovitchEmail author
Spotlight

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)...

Keywords

Improve Health Outcome Amyloid Imaging Improve Patient Health Coverage With Evidence Development Improve Patient Health Outcome 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

This work was supported by the Intramural Research Program of the NIH Clinical Center.

Conflict of interest

Peter Herscovitch declares no conflicts of interest.

Ethical standard

This article does not contain any studies with human or animal subjects performed by any of the authors.

References

  1. 1.
    Yang L, Rieves D, Ganley C (2012) Brain amyloid imaging—FDA approval of florbetapir F18 injection. N Engl J Med 367:885–887CrossRefPubMedGoogle Scholar
  2. 2.
    Hillman BJ, Frank RA, Abraham BC (2013) The medical imaging and technology alliance conference on research endpoints appropriate for medicare coverage of new PET radiopharmaceuticals. J Nucl Med 54:1675–1679CrossRefPubMedGoogle Scholar
  3. 3.
    Johnson KA, Minoshima S, Bohnen NI, Donohoe KJ, Foster NL, Herscovitch P, Karlawish JH, Rowe CC, Carrillo MC, Hartley DM, Hedrick S, Pappas V, Thies WH (2013) Appropriate use criteria for amyloid PET. J Nucl Med 54:476–490CrossRefPubMedGoogle Scholar
  4. 4.
    Fryback DG, Thornbury JR (1991) The efficacy of diagnostic imaging. Med Decis Making 11:88–94CrossRefPubMedGoogle Scholar

Copyright information

© Italian Association of Nuclear Medicine and Molecular Imaging (outside the USA) 2015

Authors and Affiliations

  1. 1.Positron Emission Tomography DepartmentNational Institutes of Health Clinical CenterBethesdaUSA

Personalised recommendations