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Assessing Personalized Medicines in Australia

Author

Listed:
  • Tracy Merlin
  • Claude Farah
  • Camille Schubert
  • Andrew Mitchell
  • Janet E. Hiller
  • Philip Ryan

Abstract

Background . Since the mapping of the human genome in 2003, the development of biomarker targeted therapy and clinical adoption of “personalized medicine†has accelerated. Models for insurance subsidy of biomarker/test/drug packages (“codependent technologies†or technologies that work better together) are not well developed. Our aim was to create a framework to assess the safety, effectiveness, and cost-effectiveness of these technologies for a national coverage or reimbursement decision. Methods . We extracted information from assessments of recent Australian reimbursement applications that concerned genetic tests and treatments to identify items and evidence gaps considered important to the decision-making process. Relevant international regulatory and reimbursement guidance documents were also reviewed. Items addressing causality theory were included to help explain the relationship between biomarker and treatment. The framework was reviewed by policy makers and technical experts, prior to a public consultation process. Results . The framework consists of 5 components—context, clinical benefit, evidence translation, cost-effectiveness, and financial impact—and a checklist of 79 items. To determine whether the biomarker test, the drug, both, or neither should be subsidized, we considered it crucial to identify whether the biomarker is a treatment effect modifier or a prognostic factor. To aid in this determination, the framework explicitly allows the linkage of different types of evidence to examine whether targeting the biomarker varies the likely clinical benefit of the drug, and if so, to what extent. Conclusions . The first national framework to assess personalized medicine for coverage or reimbursement decisions has been developed and introduced and may be a suitable model for other health systems.

Suggested Citation

  • Tracy Merlin & Claude Farah & Camille Schubert & Andrew Mitchell & Janet E. Hiller & Philip Ryan, 2013. "Assessing Personalized Medicines in Australia," Medical Decision Making, , vol. 33(3), pages 333-342, April.
  • Handle: RePEc:sae:medema:v:33:y:2013:i:3:p:333-342
    DOI: 10.1177/0272989X12452341
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    References listed on IDEAS

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    1. Meckley, Lisa M. & Neumann, Peter J., 2010. "Personalized medicine: Factors influencing reimbursement," Health Policy, Elsevier, vol. 94(2), pages 91-100, February.
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    Cited by:

    1. Veronika Kalouguina & Joël Wagner, 2020. "Challenges and Solutions for Integrating and Financing Personalized Medicine in Healthcare Systems: A Systematic Literature Review," JRFM, MDPI, vol. 13(11), pages 1-22, November.

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