Cost-effectiveness of NTRK testing strategies for detecting NTRK fusions in solid tumors in China.

3131 Background: Neurotrophic tyrosine receptor kinase (NTRK) gene fusions are oncogenic drivers in many solid tumors. With the inclusion of the targeted drug Entrectinib in China's national reimbursement drug list, the demand for NTRK testing has also increased. This study evaluates the cost-effectiveness of a two-step testing strategy (initial pan-TRK IHC testing followed by next-generation sequencing (NGS) confirmation for positive results) compared to directly conducting NGS testing, with treatment of positive cases using Entrectinib. Methods: A decision tree model was established from a health system perspective, based on clinical practices in China. The study included 17 cancer types as reported in the latest clinical trial of Entrectinib (n = 194). Diagnostic performance data were sourced from literature and validated by pathologists and clinicians. Clinical efficacy, treatment phase costs, and utility for progression-free survival (PFS) were obtained from open databases and literature. Turnaround time and costs for testing was gathered from expert interviews. The time horizon was set to include the duration of NTRK testing and the period of PFS associated with the medication. A one-way sensitivity analysis was conducted to assess the model's robustness. Results: In China, the NGS testing alone produced 0.55507 life years (LY) and 0.42646 quality-adjusted life years (QALY) at a total cost of $5932.57，whereas the pan-TRK IHC + NGS testing strategy yielded 0.55530 LY and 0.42665 QALY at a total cost of $4176.67. The pan-TRK IHC+NGS testing strategy was dominant, offering higher QALY at lower costs than NGS testing alone. Additionally, the average wait time for pan-TRK IHC + NGS testing was reduced by 10 days. The robustness of the base case results was confirmed through sensitivity analysis. Conclusions: Initial pan-TRK IHC testing, followed by NGS confirmation for positive results, is the optimal strategy for NTRK fusion detection in patients with locally advanced or metastatic solid tumors in China, providing superior cost-effectiveness compared to NGS testing alone. Cost-effectiveness analysis results. Testing Total Cost(USD$) Effectiveness (LYs) Effectiveness(QALY) Incremental cost ($) Incremental QALYs ICER (Cost/QALY) NGS $5932.57 0.55507 0.42646 pan-TRK IHC +NGS was dominant pan-TRK IHC+NGS $4176.67 0.55530 0.42665 -$1755.90 0.000187 ICER: Incremental cost-effectiveness ratio.