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Defining and quantifying the use of personalized medicines

Nature Reviews Drug Discovery volume 12, pages 896–897 (2013)Cite this article

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Despite the great attention given to personalized medicines, the pace at which they are being added to the pharmacopaeia and adopted into clinical practice has been limited. Quantifying the use of personalized medicines in multiple geographical regions over time would help monitor the extent to which different policies and health care systems might support their adoption. Here, we propose a definition for personalized medicines and provide — to our knowledge — the first replicable, objective and longitudinal quantification of worldwide use of personalized medicines, which could serve as a baseline from which to measure their future uptake.

To establish a reliable baseline, a standardized definition of personalized medicines is necessary. Here, we define a personalized medicine on the basis of it meeting one of the following two criteria:

  • A medicine that has a US Food and Drug Administration (FDA) or a European Medicines Agency label stating that its choice as a treatment must be governed by results from a companion diagnostic test.

  • A medicine that has a label that recommends (but does not require) the companion diagnostic, and at least one authoritative professional organization also recommends use of the test to guide treatment.

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Figure 1: Standard unit level and per capita utilization of personalized medicines: 1998–2009.

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Authors and Affiliations

  1. Sean X. Hu is at BioStrat Advisory LLC, 521 Topping Hill Road, Westfield, New Jersey 07090, USA.,

    Sean X. Hu

  2. Murray L. Aitken is at the IMS Institute for Healthcare Informatics, 11 Waterview Boulevard, Parsippany, New Jersey 07054, USA.,

    Murray L. Aitken

  3. Arnold M. Epstein is at the Harvard School of Public Health, 677 Huntington Avenue, Boston, Massachusetts 02115, USA.,

    Arnold M. Epstein

  4. Mark R. Trusheim and Ernst R. Berndt are at the Massachusetts Institute of Technology, Alfred P. Sloan School of Management, 100 Main Street, E62-518, Cambridge, Massachusetts 02142, USA.,

    Mark R. Trusheim & Ernst R. Berndt

Authors
  1. Sean X. Hu
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  2. Murray L. Aitken
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  3. Arnold M. Epstein
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  4. Mark R. Trusheim
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  5. Ernst R. Berndt
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Corresponding authors

Correspondence to Sean X. Hu or Mark R. Trusheim.

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Competing interests

Sean Hu, Murray Aitken, Mark Trusheim and Ernst Berndt consult for biopharmaceutical and other healthcare related firms.

Supplementary information

Supplementary information S1 (box)

Data and analysis methods (PDF 306 kb)

Supplementary information S2 (table)

Characterization of 27 unique personalized medicines identified (PDF 346 kb)

Supplementary information S3 (figure)

Personalized medicine characteristics. (PDF 306 kb)

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Hu, S., Aitken, M., Epstein, A. et al. Defining and quantifying the use of personalized medicines. Nat Rev Drug Discov 12, 896–897 (2013). https://doi.org/10.1038/nrd4177

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