Healthcare payers represent stakeholders who can act as either a bridge or a gate to the translation of personalized medicine into routine clinical practice. To date, the slow realization of the promise of personalized medicine has been partly attributable to the lack of clear evidence supporting the clinical utility of genetic and genomic tests and the lag in development of clinical guidelines for the use and interpretation of tests. These factors, along with a paucity of clear guidance from healthcare payers and clinical experience with genomic tests, serve as impediments to timely and consistent reimbursement decisions. The design of alternative strategies for collaborative evidence-generation, clinical decision support and educational initiatives for healthcare providers, patients and the payers themselves are critical needs to achieve the full benefit of personalized medicine in day-to-day healthcare settings.
Keywords: clinical utility; comparative effectiveness; genetic testing; healthcare payers; pharmacogenomics; practical clinical trials; reimbursement.