Plasma-Based Comprehensive Genomic Profiling DNA Assays for Non-Small Cell Lung Cancer: A Health Technology Assessment.

Background: Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. While some cases of NSCLC with actionable genomic alterations in the tumour cells may respond to standard therapies, they often show greater improvement with targeted therapies. The current standard of care in Ontario involves testing for actionable genomic alterations using both DNA and RNA panels via tissue testing alone. However, liquid biopsy testing may complement tissue testing by addressing some of its limitations. We conducted a health technology assessment of liquid biopsy testing using DNA panels for people with NSCLC, which included an evaluation of analytical validity, clinical validity, clinical utility, cost-effectiveness, the budget impact of publicly funding this technology, and patient preferences and values. Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the QUADAS-2, QUADAS-C, ROBINS-I, and ROBINS-E tools and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis of 4 potential liquid biopsy testing strategies in which liquid biopsy testing was added to tissue testing in various ways; our model used a 20-year time horizon and was conducted from a public payer perspective. We also analyzed the budget impact of publicly funding liquid biopsy testing for people with NSCLC in Ontario. To contextualize the potential value of liquid biopsy testing, we spoke with people with NSCLC and family members and care partners of people with NSCLC. Results: We included 61 studies in the clinical evidence review. Liquid biopsy testing demonstrated a modest sensitivity in detecting actionable genomic alterations in the Conclusions: Liquid biopsy testing has moderate to high sensitivity for detecting actionable genomic alterations in the