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

Abstract

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.

A review of the cost-effectiveness of genetic testing for germline variants in familial cancer

“…A few recent studies 17,20,21,25,45,46 saw a reduction in price of testing, yet for the most part costs remained highly variable across settings. 27,47 Assumptions on uptake of prophylactic risk reduction surgeries also influenced results and was the most predominant factor affecting cost-effectiveness in HBOC studies. Uptake rates for RRM were usually lower than those for RRSO.…”

“…26 Next-generation sequencing (NGS) has also become affordable. 27 Therefore, it would be interesting to see if the reduction in testing costs expands the utility of germline testing to populations where testing was previously known to be beneficial but cost-prohibitive. In this context, the aim of the current systematic review was to undertake a contemporary and comprehensive assessment of economic evaluations that studied the cost-effectiveness of germline testing for breast, ovarian, prostate and colorectal cancer.…”

Positive predictive value of ERBB2 copy number gain by tissue or circulating tumor DNA next-generation sequencing across advanced cancers

“…The utilization of NGS testing in advanced malignancies continues to increase dramatically as options for targeted therapies have expanded and accessibility, affordability, and efficiency of NGS testing have improved [ 8 , 9 ]. As a result, ERBB2 CNG may be discovered by NGS testing but its correlation with standard HER2 testing by IHC for overexpression or FISH for amplification, which have been validated in breast and GEA cancers to predict benefit from HER2-therapy, is less well understood.…”

State legislative trends related to biomarker testing

“…14 Between 2016 and 2019, the average amount allowed for NGS tests varied from $1269 to $2058 per test for all payees. 15 Between 2013 and 2015, the average commercial payer reimbursed amounts for single genes in patients with lung cancer ranged from $406 to $1127. 16 Based on the average reimbursement for individual mutation tests, the total reimbursement for sequential testing comprising KRAS, EGFR, ALK, ROS1, and BRAF tests was $3763, whereas the cost of NGS was $2860.…”

“…In a 2022 landscape study of biomarker testing, the average allowed unit cost per test (i.e., the negotiated rate between payers and providers before member cost sharing) for biomarker testing (single‐gene and panel tests) was $224 for commercial payers and $78.80 for Medicaid 14 . Between 2016 and 2019, the average amount allowed for NGS tests varied from $1269 to $2058 per test for all payees 15 . Between 2013 and 2015, the average commercial payer reimbursed amounts for single genes in patients with lung cancer ranged from $406 to $1127 16 .…”