ABSTRACT

The use of biomarkers combined with targeted therapies is a growing trend in many clinical areas, defining the era of “personalized medicine.” Biomarkers are indicators of normal biological processes, pathogenic processes, or responses to exposures or interventions. Molecular, histologic, radiographic, or physiologic characteristics can all be biomarkers. As newer therapeutic agents target persons with a specific genotype or specific characteristics, biomarkers allow a more targeted therapy. Biomarkers are critical to the identification of patients who would benefit from these new highly targeted therapeutic agents. This section reviews how payers use biomarkers and develop medical policy for their use; in addition, advantages for payers are reviewed. Payers want to ensure their members are receiving effective and appropriate care. Biomarker results can qualify costly therapeutic agents for insurance coverage. If a health care provider (HCP) does not submit the required biomarker result as required, the requested therapeutic agent may be denied for payment. Biomarkers can be used by payers in many ways including selecting patients, assessing the risk and severity of disease, tracking disease progression, predicting events, informing therapeutic selection, and serving as diagnostic and prognostic markers. Trends in payer biomarker adoption and management, as well as in the health economic value of biomarker use, are reviewed and provide an understanding of the value of biomarkers in the administrative as well as the clinical world.