![]() Sequential testing: Patients received a sequence of single-gene tests for alterations with FDA-approved therapies ( EGFR, ALK, ROS1, and BRAF). Upfront NGS: At mNSCLC diagnosis, patients received a panel that tested simultaneously for all alterations with and without FDA-approved therapies ( EGFR, ALK, ROS1, BRAF, MET, HER2, RET, and NTRK1). Four genomic testing strategies were considered. Alterations included in the model involved the programmed cell death protein 1 and its ligand programmed death protein 1 ligand (PD -L1), as well as genes EGFR, ALK, ROS1, BRAF, KRAS, MET, HER2, RET, and NTRK1. In addition, the budget impact of increasing NGS testing was assessed from the perspective of both CMS and a US commercial payer.Ī decision analytic model was developed in Microsoft Excel 2016 from the perspective of CMS and a US commercial payer for patients with newly diagnosed mNSCLC who were eligible for genomic testing to determine mNSCLC alteration status and inform treatment selection. We also estimated the proportion of patients with mNSCLC identified by each testing strategy as harboring alterations with and without FDA-approved therapies. Therefore, a decision analytic model was developed to estimate the difference in testing costs and time-to-test results between NGS and commonly used single-gene testing strategies among patients with mNSCLC from the perspective of the Centers for Medicare & Medicaid Services (CMS) and a US commercial payer. 16, 17 In addition, given the relatively recent development of NGS, there is a need to better understand the economic implications of using NGS versus other testing strategies in real-world clinical practice. In recent years, next-generation sequencing (NGS) has emerged as a reliable strategy to simultaneously test for multiple alterations using a single tissue sample 14 however, only a small percentage of patients with NSCLC currently receive NGS, 15 as a number of practical barriers hinder its wider adoption, including limited patient access, a lack of awareness and communication within medical care teams about the benefits of NGS, limited coverage, and low reimbursement rates. However, a biopsy may fail, lead to complications, add to costs, and cause inconvenience and discomfort to patients even when successful. 11- 13 As a result, one or more rebiopsies may be needed to complete the sequence. 10 In either case, running a sequence of single-gene tests can be time consuming and may require a relatively large tissue sample, which is not always available as NSCLC is often detected at an advanced stage and only small biopsy samples are usually attainable. 10 Sequences of single-gene tests can also be used without hotspot panel, typically testing for the most common alterations first and less common alterations last. 10 In the case of negative results, the panel is generally followed by a sequence of single-gene tests for less common alterations. Frequently, a hotspot panel is used to test patients for a handful of common genomic alterations. 2, 9 Currently, a number of testing strategies are available with which to identify genomic alterations in NSCLC. ![]() Targeted therapies have been demonstrated to significantly improve treatment response and progression-free survival 7- 9 therefore, it is important to identify patients with specific genomic alterations to individualize treatment and optimize outcomes. Stakeholders should consider moving to NGS as the preferred method for biomarker testing. Our model illustrates that moving from sequential single-gene tests or even panels of tests to broader NGS testing for patients with advanced NSCLC is already the best strategy in these three areas and will only become more relevant as the list of tests grows. Upfront NGS testing also results in the largest number of patients with targetable genetic alterations being identified in the shortest period of time.Īs more clinically relevant genetic targets in NSCLC emerge that require routine testing at diagnosis, it is vital to identify the molecular testing strategy that is timeliest, spares the most tissue, and is most cost efficient, as this must be done in every new patient. Upfront next-generation sequencing (NGS) testing for all relevant molecular targets in NSCLC is less costly than performing single-gene testing, no matter what testing strategy is used. To determine the least costly strategy for testing for all recommended molecular abnormalities in patients with non–small-cell lung cancer (NSCLC) at diagnosis.
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