Access to personalized medicine: Factors influencing the use and value of gene expression profiling in treatment decision making.

10 Background: Genomic information is increasingly used to personalize health care. One example is gene-expression profiling (GEP) tests that estimate recurrence risk to inform chemotherapy decisions in breast cancer treatment. Recently, GEP tests were publicly funded in Ontario. We assessed the clinical utility of GEP tests, exploring the factors facilitating their use and value in treatment decision-making. Methods: As part of a mixed-methods clinical utility study, we conducted interviews with oncologists (n=14), and focus groups and interviews with breast cancer patients (n=28) who underwent GEP, recruited through oncology clinics in Ontario. Data were analyzed using content analysis and constant comparison. Results: Various factors governing access to GEP have given rise to challenges for patients and oncologists. Oncologists are positioned as gatekeepers of GEP, providing access in medically appropriate cases. However, varying perceptions of appropriateness led to perceived inequities in access and negative impacts on the doctor-patient relationship. Media attention facilitated patient awareness of GEP but complicated gatekeeping. Additional administration burden and long waits for results led to increased patient anxiety and delayed treatment. Collectively, these factors inadvertently heightened GEP’s perceived value for patients relative to other prognostic indicators because of barriers to access. Conclusions: This study delineates the factors facilitating and restricting access to GEP, and highlights the roles of the media and organization of services in GEP’s perceived value and utilization. Results identify a need for administrative changes and practice guidelines to support streamlined and standardized utilization of the test.