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Pharmacogenetic Testing & Characteristics and Metrics

    Basic Details
    Last Updated
    Friday, June 14, 2024
    Original Posting Date
    Health Outcome(s)
    characteristics and metrics
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    The increasing use of genomic tests for diseases has great potential to improve health outcomes because of the trend toward targeted therapeutics such as personalizing treatments by genotype. Prescribing information for FDA-approved drugs may contain information on genomic biomarkers that can identify responders and non-responders to medications. However, few assessments on the use of genomic tests have been completed, because of the limitation of the existing administrative healthcare data, given the laboratories have traditionally billed for genetic testing using stacking codes that describe each step of the procedure required to perform a genetic test. Therefore, the goal of this study was to assess the feasibility of identifying genetic tests, their rates of use, and baseline characteristics of tested patients in the Sentinel Distributed Database (SDD).

    Using the SDD for the time period of January 1, 2013, to December 31, 2015, FDA estimated the number of incident users of cetuximab, panitumumab, trametinib, dabrafenib, vemurafenib, cobimetinib, afatinib, erlotinib, tagrisso, gefitinib, dasatinib, imatinib, bosutinib, nilotinib, and ponatinib, and the utilization of five different genetic tests of the respective genes V-Ki-ras2 Kirsten rat sarcoma viral oncogene (KRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), epidermal growth factor receptor (EGFR), breakpoint cluster region-abelson (BCR-ABL), and the breast cancer susceptibility gene (BRCA) were estimated. Cetuximab and panitumumab were reported in 5,220 new users (0.08 new users/1000 eligible members). Dasatinib, imatinib, bosutinib, nilotinib, and ponatinib were reported in 3,545 new users (0.06 new users/1000 eligible members). The KRAS, BRAF, EGFR, BCR-AB and BRCA genetic tests were received by 5,210, 4,907, 4,730, 5,360, and 23,111 participants respectively.
    These results informed the FDA about the feasibility and limitations of using the Sentinel System and existing tools to assess the use of genetic testing.