Paper

Pharmacogenomics, Evidence, and the Role of Payers
P.A. Deverka

UNC Institute for Pharmacogenomics and Individualized Therapy, Division of Pharmacotherapy and Experimental Therapeutics, University of North Carolina, Chapel Hill, N.C., USA

Address of Corresponding Author

Public Health Genomics 2009;12:149-157 (DOI: 10.1159/000189627)

  Key Words

• Evidence-based medicine
• Health policy
• Insurance coverage
• Pharmacogenomics
• Reimbursement incentive
• Reimbursement mechanisms

  Abstract

Initial enthusiasm for the potential of pharmacogenomics (PGx) to transform medical practice has been tempered by the reality that the process of biomarker discovery, validation, and clinical qualification has been disappointingly slow, with a limited number of PGx tests entering the marketplace since the initial publication of the human genome sequence. Reasons for the delays include the complexity of the underlying science as well as clinical, economic, and organizational barriers to the effective delivery of personalized health care. Nevertheless, payers are interested in using PGx services to ensure that drug use is safer and more effective, particularly in the settings of medications that are widely used, have significant risks of serious adverse events, have poor or highly variable drug response, or are very expensive. However, public and private payers have specific evidence requirements for new health care technologies that must be met prior to obtaining favorable coverage and reimbursement status. These evaluation criteria are frequently more rigorous than the current level of evidence required for regulatory approval of new PGx tests or PGx-related drug labeling. To support payer decision-making, researchers will need to measure the impact of PGx testing on clinical and economic outcomes and demonstrate the net benefit of PGx testing as compared to usual care. By linking payer information needs with the current PGx research agenda, there is the opportunity to develop the data required for informed decision-making. This strategy will increase the likelihood that PGx services will be both reimbursed and used appropriately in clinical practice.

Copyright © 2009 S. Karger AG, Basel

  Author Contacts

Patricia Deverka, MD, MS, MBE
UNC Institute for Pharmacogenomics and Individualized Therapy
University of North Carolina, Chapel Hill
Campus Box 7360, Kerr Hall, Chapel Hill, NC 27599-7360 (USA)
Tel. +1 480 248 6416, E-Mail pat_deverka@unc.edu

  Article Information

Published online: February 10, 2009
Number of Print Pages : 9
Number of Figures : 0, Number of Tables : 3, Number of References : 56