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Costs of biomarker testing in advanced non-small cell lung cancer: a global study comparing next-generation sequencing and single-gene testing

U. Malapelle, CC. Chen, E. de Álava, P. Hofman, D. Kazdal, TJ. Kim, TKH. Lim, A. Ryška, AA. Saetta, E. Schuuring, G. Troncone, M. Biscuola, YL. Chen, GS. Tan, CH. Marquette, M. Michelli, A. Ter Elst, H. Vošmiková, J. Kapp, S. Gonzalez-McQuire, A....

. 2025 ; 11 (2) : e70018. [pub] -

Language English Country England, Great Britain

Document type Journal Article, Observational Study, Comparative Study, Multicenter Study

Grant support
Amgen (Europe), Rotkreuz, Switzerland

Current European/US guidelines recommend that molecular testing in advanced non-small cell lung cancer (aNSCLC) be performed using next-generation sequencing (NGS). However, the global uptake of NGS is limited, largely owing to reimbursement constraints. We compared real-world costs of NGS and single-gene testing (SGT) in nonsquamous aNSCLC. This observational study was conducted across 10 pathology centers in 10 different countries worldwide. Biomarker data collected via structured questionnaires (1 January-31 December 2021) were used to feed micro-costing analyses for three scenarios ['Starting Point' (SP; 2021-2022), 'Current Practice' (CP; 2023-2024), and 'Future Horizons' (FH; 2025-2028)] in both a real-world model, comprising all biomarkers tested by each center, and a standardized model, comprising the same sets of biomarkers across centers. Testing costs (including retesting) encompassed personnel costs, consumables, equipment, and overheads. Overall, 4,491 patients with aNSCLC were evaluated. Mean per-patient costs decreased for NGS relative to SGT over time, with real-world model costs 18% lower for NGS than for SGT in the SP scenario, and 26% lower for NGS than for SGT in the CP scenario. Mean per-biomarker costs also decreased over time for NGS relative to SGT. In the standardized model, the tipping point for the minimum number of biomarkers required for NGS to result in cost savings (per patient) was 10 and 12 in the SP and CP scenarios, respectively. Retesting had a negligible impact on cost analyses, and results were robust to variation in cost parameters. This study provides robust real-world global evidence for cost savings with NGS-based panels over SGT to evaluate predictive biomarkers in nonsquamous aNSCLC when the number of biomarkers to be tested exceeds 10. Widespread adoption of NGS may enable more efficient use of limited healthcare resources.

Amgen Rotkreuz Switzerland

Department of Hospital Pathology Yeouido St Mary's Hospital College of Medicine The Catholic University of Korea Seoul Republic of Korea

Department of Normal and Pathological Cytology and Histology School of Medicine University of Seville Seville Spain

Department of Pathology and Medical Biology University Medical Center Groningen University of Groningen Groningen The Netherlands

Department of Pathology Ditmanson Medical Foundation Chia Yi Christian Hospital Chia Yi Taiwan

Department of Pathology National Cheng Kung University Hospital College of Medicine National Cheng Kung University Tainan Taiwan

Department of Public Health University of Naples Federico 2 Naples Italy

Department of Thoracic Oncology University Cote d'Azur CHU de Nice IHU RespirERA Nice France

Division of Pathology Singapore General Hospital Singapore

Institute of Pathology University Hospital Heidelberg Center for Personalized Medicine Heidelberg Germany

Laboratory of Clinical and Experimental Pathology IHU RespirERA FHU OncoAge Biobank 0033 00025 University Côte d'Azur Nice France

Life Sciences Division BIP Consulting Milan Italy

Molecular Diagnostic Unit 1st Department of Pathology School of Medicine National and Kapodistrian University of Athens Athens Greece

The Fingerland Department of Pathology Charles University Faculty of Medicine and University Hospital Hradec Králové Czech Republic

Translational Lung Research Center Heidelberg Heidelberg Germany

Virgen del Rocio University Hospital Institute of Biomedicine of Sevilla CSIC University of Sevilla CIBERONC Seville Spain

References provided by Crossref.org

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