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

Abstract 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...

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Main Authors: Umberto Malapelle, Chien‐Chin Chen, Enrique deÁlava, Paul Hofman, Daniel Kazdal, Tae‐Jung Kim, Tony Kiat Hon Lim, Aleš Ryška, Angelica A Saetta, Ed Schuuring, Giancarlo Troncone, Michele Biscuola, Yi‐Lin Chen, Gek San Tan, Charles Hugo Marquette, Maria Michelli, Arja terElst, Hana Vošmiková, Joshua Kapp, Sebastian Gonzalez‐McQuire, Andromachi Giannopoulou, Jean Marie Franzini, Victoria Lucia Rabsiun Aramburu, Anna Baggi, Albrecht Stenzinger
Format: Article
Language:English
Published: Wiley 2025-03-01
Series:The Journal of Pathology: Clinical Research
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Online Access:https://doi.org/10.1002/2056-4538.70018
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author Umberto Malapelle
Chien‐Chin Chen
Enrique deÁlava
Paul Hofman
Daniel Kazdal
Tae‐Jung Kim
Tony Kiat Hon Lim
Aleš Ryška
Angelica A Saetta
Ed Schuuring
Giancarlo Troncone
Michele Biscuola
Yi‐Lin Chen
Gek San Tan
Charles Hugo Marquette
Maria Michelli
Arja terElst
Hana Vošmiková
Joshua Kapp
Sebastian Gonzalez‐McQuire
Andromachi Giannopoulou
Jean Marie Franzini
Victoria Lucia Rabsiun Aramburu
Anna Baggi
Albrecht Stenzinger
author_facet Umberto Malapelle
Chien‐Chin Chen
Enrique deÁlava
Paul Hofman
Daniel Kazdal
Tae‐Jung Kim
Tony Kiat Hon Lim
Aleš Ryška
Angelica A Saetta
Ed Schuuring
Giancarlo Troncone
Michele Biscuola
Yi‐Lin Chen
Gek San Tan
Charles Hugo Marquette
Maria Michelli
Arja terElst
Hana Vošmiková
Joshua Kapp
Sebastian Gonzalez‐McQuire
Andromachi Giannopoulou
Jean Marie Franzini
Victoria Lucia Rabsiun Aramburu
Anna Baggi
Albrecht Stenzinger
author_sort Umberto Malapelle
collection DOAJ
description Abstract 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.
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spelling doaj-art-e5f2c7a5b1b34f7dad03b0b12b5362ed2025-08-20T01:50:06ZengWileyThe Journal of Pathology: Clinical Research2056-45382025-03-01112n/an/a10.1002/2056-4538.70018Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testingUmberto Malapelle0Chien‐Chin Chen1Enrique deÁlava2Paul Hofman3Daniel Kazdal4Tae‐Jung Kim5Tony Kiat Hon Lim6Aleš Ryška7Angelica A Saetta8Ed Schuuring9Giancarlo Troncone10Michele Biscuola11Yi‐Lin Chen12Gek San Tan13Charles Hugo Marquette14Maria Michelli15Arja terElst16Hana Vošmiková17Joshua Kapp18Sebastian Gonzalez‐McQuire19Andromachi Giannopoulou20Jean Marie Franzini21Victoria Lucia Rabsiun Aramburu22Anna Baggi23Albrecht Stenzinger24Department of Public Health University of Naples Federico II Naples ItalyDepartment of Pathology Ditmanson Medical Foundation Chia‐Yi Christian Hospital Chia‐Yi TaiwanVirgen del Rocio University Hospital, Institute of Biomedicine of Sevilla (IBiS), CSIC University of Sevilla, CIBERONC Seville SpainLaboratory of Clinical and Experimental Pathology, IHU RespirERA, FHU OncoAge, Biobank 0033‐00025 University Côte d'Azur Nice FranceInstitute of Pathology University Hospital Heidelberg, Center for Personalized Medicine (ZPM) Heidelberg GermanyDepartment of Hospital Pathology, Yeouido St. Mary's Hospital, College of Medicine The Catholic University of Korea Seoul Republic of KoreaDivision of Pathology Singapore General Hospital SingaporeThe Fingerland Department of Pathology Charles University Faculty of Medicine and University Hospital Hradec Králové Czech RepublicMolecular Diagnostic Unit, First Department of Pathology, School of Medicine National and Kapodistrian University of Athens Athens GreeceDepartment of Pathology and Medical Biology University Medical Center Groningen, University of Groningen Groningen The NetherlandsDepartment of Public Health University of Naples Federico II Naples ItalyVirgen del Rocio University Hospital, Institute of Biomedicine of Sevilla (IBiS), CSIC University of Sevilla, CIBERONC Seville SpainDepartment of Pathology, National Cheng Kung University Hospital, College of Medicine National Cheng Kung University Tainan TaiwanDivision of Pathology Singapore General Hospital SingaporeDepartment of Thoracic Oncology University Cote d'Azur, CHU de Nice, IHU RespirERA Nice FranceMolecular Diagnostic Unit, First Department of Pathology, School of Medicine National and Kapodistrian University of Athens Athens GreeceDepartment of Pathology and Medical Biology University Medical Center Groningen, University of Groningen Groningen The NetherlandsThe Fingerland Department of Pathology Charles University Faculty of Medicine and University Hospital Hradec Králové Czech RepublicAmgen (Europe) Rotkreuz SwitzerlandAmgen (Europe) Rotkreuz SwitzerlandAmgen (Europe) Rotkreuz SwitzerlandLife Sciences Division BIP Consulting Milan ItalyLife Sciences Division BIP Consulting Milan ItalyLife Sciences Division BIP Consulting Milan ItalyInstitute of Pathology University Hospital Heidelberg, Center for Personalized Medicine (ZPM) Heidelberg GermanyAbstract 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.https://doi.org/10.1002/2056-4538.70018cost comparisonnext‐generation sequencingNSCLCprecision medicinepredictive biomarkersingle‐gene testing
spellingShingle Umberto Malapelle
Chien‐Chin Chen
Enrique deÁlava
Paul Hofman
Daniel Kazdal
Tae‐Jung Kim
Tony Kiat Hon Lim
Aleš Ryška
Angelica A Saetta
Ed Schuuring
Giancarlo Troncone
Michele Biscuola
Yi‐Lin Chen
Gek San Tan
Charles Hugo Marquette
Maria Michelli
Arja terElst
Hana Vošmiková
Joshua Kapp
Sebastian Gonzalez‐McQuire
Andromachi Giannopoulou
Jean Marie Franzini
Victoria Lucia Rabsiun Aramburu
Anna Baggi
Albrecht Stenzinger
Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing
The Journal of Pathology: Clinical Research
cost comparison
next‐generation sequencing
NSCLC
precision medicine
predictive biomarker
single‐gene testing
title Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing
title_full Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing
title_fullStr Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing
title_full_unstemmed Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing
title_short Costs of biomarker testing in advanced non‐small cell lung cancer: a global study comparing next‐generation sequencing and single‐gene testing
title_sort costs of biomarker testing in advanced non small cell lung cancer a global study comparing next generation sequencing and single gene testing
topic cost comparison
next‐generation sequencing
NSCLC
precision medicine
predictive biomarker
single‐gene testing
url https://doi.org/10.1002/2056-4538.70018
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