Real-world trends in costs of next generation sequencing (NGS) testing in US setting.

e18824 Background: Recent advances in NGS testing have revolutionized the scope for personalized medicine. The goal of this study was to describe historic trends in the average allowed cost for NGS testing. Methods: This was a retrospective database study evaluating biomarker testing claims in patients undergoing tumor and/or germline sequencing tests between 2016-2019. Molecular testing claims data and marketplace data of tests currently sold in the U.S. were analyzed in the proprietary Concert Genetics Medical Claims Data Warehouse. Results: Analysis of data highlighted high variability in utilization rates as well as allowed amounts for NGS testing. The average allowed amounts for NGS Tests varied from $1269 to $2058 per test during the study period. Higher variability in billing codes and price was also observed when analysis was done for subgroups, which included region, age, gender and cancer type. Similar trends were also observed for panels containing NGS-derived tests such as Tumor Mutation Burden (TMB), an upcoming biomarker. Average allowed amounts for NGS tests that included TMB testing varied from $438 to $3700 per test. To gain a better perspective on evolution of coding, utilization and pricing trends, additional analyses were done in hereditary cancer, given longer availability of these tests in the US Market. For Hereditary cancers, the average allowed amounts varied from $1722 to $2249 per test during the study period. Greater consistency in price was observed in hereditary cancer. Utilization is also more consistent over time and price showed a gradual decreasing trend over time. Coding was also less variable per claim for hereditary cancer and showed a converging trend. Conclusions: Understanding and quantifying the trends in cost of NGS testing for novel biomarkers is critical to predict evolution of testing costs and provide insights essential for minimizing barriers to availability and affordability of these tests. NGS testing can play an important role in improving quality of care and making the clinical decision-making process more efficient. Currently, coverage and reimbursement of NGS tests is one of the key policy challenges that needs to be addressed. Hence, development and adoption of policies is needed to ensure efficient integration of NGS testing in the US health care system.