Health and Budget Impact of Liquid-Biopsy-Based Comprehensive Genomic Profile (CGP) Testing in Tissue-Limited Advanced Non-Small Cell Lung Cancer (aNSCLC) Patients

Abstract

BACKGROUND AND OBJECTIVES: Molecular genetic testing using tissue biopsies can be challenging for patients due to unfavorable tumor sites, the invasive nature of a tissue biopsy, and the added time of booking a repeat biopsy (re-biopsy). Centers in Canada have found insufficient tissue rates to be approximately 10%, and even among successful biopsies, insufficient DNA in tissue samples is approximately 16%, triggering the lengthy process of re-biopsies. Using aNSCLC as an example, this study sought to characterize the health and budget impact of alternative liquid-biopsy(LBx)-based comprehensive genomic profile (CGP) testing in tissue-limited patients (TL-LBx-CGP) from a Canadian publicly funded healthcare perspective. MATERIAL AND METHODS: An economic model was developed to estimate the incremental cost and life-years gained as a population associated with adopting TL-LBx-CGP. The eligible patient population was modeled using a top-down epidemiological approach based on the published literature and expert clinician input. Treatment allocation was modeled based on biomarker prevalence in the published literature, and the availability of funded therapies. Costs included molecular testing, as well as drug, administrative, and supportive costs, and relevant health data included median overall survival and median progression-free survival data. RESULTS: Incorporation of TL-LBx-CGP demonstrated an overall impact of $14.7 million with 168 life-years gained to the Canadian publicly funded healthcare system in the 3-year time horizon.

Economic Analysis of Tissue-First, Plasma-First, and Complementary NGS Approaches for Treatment-Naïve Metastatic Lung Adenocarcinoma

“…Although previous studies have demonstrated that the prevailing tissue-based NGS is a cost-efficient and time-saving strategy ( 5 ) and liquid-based NGS for patients, with insufficient tissue specimens, adds lives with a modest budget impact ( 8 ), there has been no research comparing the testing costs and testing turnaround times of three NGS approaches. This study addressed the false-negative results of liquid-based NGS and re-biopsy issues.…”

“…Cost evaluation studies using Italian multicenter data also highlighted that the adoption of NGS saves personnel time and reduces the overall cost of testing ( 6 , 7 ). Another study found that in patients with insufficient tissue specimens, liquid-based NGS adds lives with a modest budget impact ( 8 ). However, to date, there is no study directly comparing the testing costs and testing turnaround times of tissue-first, plasma-first, and complementary NGS approaches for patients with treatment-naïve metastatic lung adenocarcinoma.…”

An Overview of Comprehensive Genomic Profiling Technologies to Inform Cancer Care

“…Tissue exhaustion may limit the number of repeat samples that can be collected for further tissue-based assays. 27 Some tissue-based CGP tests are emerging that can detect multiple genes at once, which may help reduce some of these limitations. For example, the Oncomine Comprehensive Assay (Thermo Fisher Scientific, US) can profile more than 500 genes, and both Foundation Medicine and Imagia Canexia Health have tissue-based CGP assays that characterize a similar panel of mutations as their liquid-based tests, but with different sampling requirements.…”

“…9 Sample collection and analysis, testing infrastructure, the need for sufficient volume of tests, determining which cancer types may be eligible for testing, and the effect on access to targeted therapies will be important for estimating overall cost implications for health systems. 9,27,40 The costs of different tests may not be comparable because they may have different analysis capabilities and/or requirements for sending samples to central laboratories or performing in-house analysis or assessing different genomic features. As such, prices of some tests presented in this report are not for direct comparison but to provide a general indication about the variability in potential costs.…”

Patient and Clinician Preferences for Genetic and Genomic Testing in Non-Small Cell Lung Cancer: A Discrete Choice Experiment

“…Current standard of care diagnostic testing for NSCLC in Australia includes sequential single-gene testing for EGFR , ALK and ROS1 which are prioritised due to their population prevalence and subsidised treatments [ 9 , 10 , 12 ]. Unfortunately, this approach has several disadvantages, including testing inefficiencies and tissue exhaustion, resulting in high rates of repeat biopsy (approximately 30%) [ 13 , 14 ]. Given the rapid and exponential emergence of new clinically relevant genomic alterations and associated targeted therapies, there is a substantial unmet need for a more comprehensive and efficient approach to identify genetic and genomic alterations.…”