• Value Health · Dec 2012

    Challenges in the development and reimbursement of personalized medicine-payer and manufacturer perspectives and implications for health economics and outcomes research: a report of the ISPOR personalized medicine special interest group.

    • Eric Faulkner, Lieven Annemans, Lou Garrison, Mark Helfand, Anke-Peggy Holtorf, John Hornberger, Dyfrig Hughes, Tracy Li, Daniel Malone, Katherine Payne, Uwe Siebert, Adrian Towse, David Veenstra, John Watkins, and Personalized Medicine Development and Reimbursement Working Group.
    • Quintiles Global Consulting, Durham, NC 13979, USA. Eric.Faulkner@quintiles.com
    • Value Health. 2012 Dec 1; 15 (8): 1162-71.

    BackgroundPersonalized medicine technologies can improve individual health by delivering the right dose of the right drug to the right patient at the right time but create challenges in deciding which technologies offer sufficient value to justify widespread diffusion. Personalized medicine technologies, however, do not neatly fit into existing health technology assessment and reimbursement processes.ObjectivesIn this article, the Personalized Medicine Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research evaluated key development and reimbursement considerations from the payer and manufacturer perspectives.MethodsFive key areas in which health economics and outcomes research best practices could be developed to improve value assessment, reimbursement, and patient access decisions for personalized medicine have been identified.ResultsThese areas are as follows: 1 research prioritization and early value assessment, 2 best practices for clinical evidence development, 3 best practices for health economic assessment, 4 addressing health technology assessment challenges, and 5 new incentive and reimbursement approaches for personalized medicine.ConclusionsKey gaps in health economics and outcomes research best practices, decision standards, and value assessment processes are also discussed, along with next steps for evolving health economics and outcomes research practices in personalized medicine.Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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