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Updated: Sep 29, 2025
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Clinical and economic impact of 'ROS1-testing' strategy compared to a 'no-ROS1-testing' strategy in advanced NSCLC in
Federico Rojo1, Esther Conde2, Héctor Torres3
1Hospital Universitario Fundación Jiménez Diaz - CIBERONC, Madrid, Spain.
Background:
Detection of the ROS1 rearrangement is mandatory in patients with advanced or metastatic non-small cell lung cancer (NSCLC) to allow targeted therapy with specific inhibitors. However, in Spanish clinical practice ROS1 determination is not yet fully widespread. The aim of this study is to determine the clinical and economic impact of sequentially testing ROS1 in addition to EGFR and ALK in Spain.
Methods:
A joint model (decision-tree and Markov model) was developed to determine the cost-effectiveness of testing ROS1 strategy versus a no-ROS1 testing strategy in Spain. Distribution of ROS1 techniques, rates of testing, positivity, and invalidity of biomarkers included in the analysis (EGFR, ALK, ROS1 and PD-L1) were based on expert opinion and Lungpath real-world database. Treatment allocation depending on the molecular testing results was defined by expert opinion. For each treatment, a 3-states Markov model was developed, where progression-free survival (PFS) and overall survival (OS) curves were parameterized using exponential extrapolations to model transition of patients among health states. Only medical direct costs were included (€ 2021). A lifetime horizon was considered and a discount rate of 3% was applied for both costs and effects. Both deterministic and probabilistic sensitivity analyses were performed to address uncertainty.
Results:
A target population of 8755 patients with advanced NSCLC (non-squamous or never smokers squamous) entered the model. Over a lifetime horizon, the ROS1 testing scenario produced additional 157.5 life years and 121.3 quality-adjusted life years (QALYs) compared with no-ROS1 testing scenario. Total direct costs were increased up to € 2,244,737 for ROS1 testing scenario. The incremental cost-utility ratio (ICUR) was 18,514 €/QALY. Robustness of the base-case results were confirmed by the sensitivity analysis.
Conclusions:
Our study shows that ROS1 testing in addition to EGFR and ALK is a cost-effective strategy compared to no-ROS1 testing, and it generates more than 120 QALYs in Spain over a lifetime horizon. Despite the low prevalence of ROS1 rearrangements in NSCLC patients, the clinical and economic consequences of ROS1 testing should encourage centers to test all advanced or metastatic NSCLC (non-squamous and never-smoker squamous) patients.
Insights
Testing for ROS1 rearrangements in non-small cell lung cancer (NSCLC) patients is cost-effective in Spain. This strategy improves life years and quality-adjusted life years (QALYs) compared to no ROS1 testing.
Area of Science:
- Oncology
- Health Economics
- Biomarker Testing
Background:
- Detection of ROS1 rearrangement is mandatory for targeted therapy in advanced non-small cell lung cancer (NSCLC).
- ROS1 testing is not yet widespread in Spanish clinical practice.
- This study evaluates the clinical and economic impact of adding ROS1 testing to EGFR and ALK in Spain.
Purpose of the Study:
- To determine the cost-effectiveness of a ROS1 testing strategy versus no ROS1 testing in Spain.
- To assess the clinical benefits, including life years and QALYs gained.
- To analyze the direct medical costs associated with ROS1 testing.
Main Methods:
- A joint decision-tree and Markov model was developed for cost-effectiveness analysis.
- Data on biomarker testing rates and outcomes were sourced from expert opinion and the Lungpath real-world database.
- Patient survival curves (PFS and OS) were modeled using exponential extrapolations over a lifetime horizon with a 3% discount rate.
Main Results:
- The ROS1 testing scenario yielded an additional 157.5 life years and 121.3 QALYs compared to no ROS1 testing.
- Total direct medical costs increased by €2,244,737 for the ROS1 testing strategy.
- The incremental cost-utility ratio (ICUR) was €18,514 per QALY, indicating cost-effectiveness.
Conclusions:
- ROS1 testing, alongside EGFR and ALK, is a cost-effective strategy for advanced NSCLC in Spain.
- The strategy generates significant clinical benefits, adding over 120 QALYs over a lifetime.
- Despite low ROS1 prevalence, widespread testing in advanced NSCLC patients is clinically and economically justified.
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