Where Do We Need Best Practices In Development And Reimbursement Of Personalized Medicine?

Durham, NC, USA – Personalized medicine technologies are currently caught between high expectations of improving health outcomes and uncertainty about navigating the rapidly changing regulatory and reimbursement environment. This is because they do not fit neatly into the existing routes by which traditional biopharmaceuticals and diagnostics reach the market — including health technology assessment and reimbursement processes. In order for the field to optimally evolve, establishment of HEOR best practices that are consistent and transparent to both manufacturers and payers will be required.

In the article, “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 Development and Reimbursement Working Group,” published in Value in Health, the Personalized Medicine Special Interest Group (SIG) of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) examined challenges relating to development and reimbursement from the payer and manufacturer perspectives. These two stakeholder groups have a major impact on development and uptake of novel, personalized therapies.

The SIG sought to address key challenges associated with personalized medicine including the translation of knowledge into clinical practice, demonstrating value and delivering the new technologies through evolving health care models and the implications for HEOR. The paper identified five major areas in particular need of best practice development: research prioritization and early value assessment; clinical evidence development; health economic assessment; addressing health technology assessment challenges; and new incentive and reimbursement approaches for personalized medicine.

“Personalized medicine is a rapidly evolving field and many markets are beginning to develop processes and criteria focused on evaluation and uptake of these technologies.” says Eric Faulkner, Chair of the ISPOR Personalized Medicine Reimbursement & Development Working Group, and Director, Global Market Access, Consulting at Quintiles. “As with any new area, there are decision and methodological challenges, including those where new HEOR approaches can help streamline value assessment – ISPOR is a driving force toward this objective. The SIG paper seeks to identify key areas where development of best practices may help ensure appropriate evaluation of personalized medicine technologies.”


Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research as well as policy papers to help health care leaders make evidence-based decisions. The journal is published bi-monthly and has over 8,000 subscribers (clinicians, decision makers, and researchers worldwide).

International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.

For more information: www.ispor.org

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