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 C Malone, Katherine Payne, Uwe Siebert, Adrian Towse, David Veenstra, John Watkins

Research output: Contribution to journalArticle

77 Scopus citations


Background: Personalized 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. Objectives: In 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. Methods: Five 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. Results: These 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. Conclusions: Key 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.

Original languageEnglish (US)
Pages (from-to)1162-1171
Number of pages10
JournalValue in Health
Issue number8
Publication statusPublished - Dec 2012



  • diagnostics
  • health economics and outcomes research
  • health technology assessment
  • personalized medicine
  • reimbursement

ASJC Scopus subject areas

  • Health Policy
  • Public Health, Environmental and Occupational Health

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