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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

. 2025 Mar ; 11 (2) : e70018.

Language English Country England, Great Britain Media print

Document type Journal Article, Comparative Study, Observational 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

See more in PubMed

American Cancer Society . Cancer Facts & Figures 2024. [Accessed 13 January 2025]. Available from: https://www.cancer.org/content/dam/cancer‐org/research/cancer‐facts‐and‐statistics/annual‐cancer‐facts‐and‐figures/2024/2024‐cancer‐facts‐and‐figures‐acs.pdf

Ganti AK, Klein AB, Cotarla I, et al. Update of incidence, prevalence, survival, and initial treatment in patients with non‐small cell lung cancer in the US. JAMA Oncol 2021; 7: 1824–1832. PubMed PMC

Michelotti A, de Scordilli M, Bertoli E, et al. NSCLC as the paradigm of precision medicine at its finest: the rise of new druggable molecular targets for advanced disease. Int J Mol Sci 2022; 23: 6748. PubMed PMC

Sholl LM, Cooper WA, Kerr KM, et al. In: IASLC Atlas of Molecular Testing for Targeted Therapy in Lung Cancer, Sholl LM, Cooper WA, Kerr KM, et al. (Eds). International Association for the Study of Lung Cancer, 2023.

de Jager VD, Timens W, Bayle A, et al. Developments in predictive biomarker testing and targeted therapy in advanced stage non‐small cell lung cancer and their application across European countries. Lancet Reg Health Eur 2024; 38: 100838. PubMed PMC

Hendriks LE, Kerr KM, Menis J, et al. Oncogene‐addicted metastatic non‐small‐cell lung cancer: ESMO clinical practice guideline for diagnosis, treatment and follow‐up. Ann Oncol 2023; 34: 339–357. PubMed

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non‐Small Cell Lung Cancer V.5.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. [Accessed 1 May 2024]. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

Hendriks LE, Kerr KM, Menis J, et al. Non‐oncogene‐addicted metastatic non‐small‐cell lung cancer: ESMO clinical practice guideline for diagnosis, treatment and follow‐up. Ann Oncol 2023; 34: 358–376. PubMed

Mosele MF, Westphalen CB, Stenzinger A, et al. Recommendations for the use of next‐generation sequencing (NGS) for patients with advanced cancer in 2024: a report from the ESMO Precision Medicine Working Group. Ann Oncol 2024; 35: 588–606. PubMed

Bestvina CM, Waters D, Morrison L, et al. Cost of genetic testing, delayed care, and suboptimal treatment associated with polymerase chain reaction versus next‐generation sequencing biomarker testing for genomic alterations in metastatic non‐small cell lung cancer. J Med Econ 2024; 27: 292–303. PubMed

de Alava E, Pareja MJ, Carcedo DA‐O, et al. Cost‐effectiveness analysis of molecular diagnosis by next‐generation sequencing versus sequential single testing in metastatic non‐small cell lung cancer patients from a south Spanish hospital perspective. Expert Rev Pharmacoecon Outcomes Res 2022; 22: 1033–1042. PubMed

Pennell NA, Mutebi A, Zhou Z‐Y, et al. Economic impact of next‐generation sequencing versus single‐gene testing to detect genomic alterations in metastatic non–small‐cell lung cancer using a decision analytic model. JCO Precis Oncol 2019; 3: 1–9. PubMed

Wolff HB, Steeghs EMP, Mfumbilwa ZA, et al. Cost‐effectiveness of parallel versus sequential testing of genetic aberrations for stage IV non‐small‐cell lung cancer in the Netherlands. JCO Precis Oncol 2022; 6: e2200201. PubMed PMC

Cainap C, Balacescu O, Cainap SS, et al. Next generation sequencing technology in lung cancer diagnosis. Biology (Basel) 2021; 10: 864. PubMed PMC

Nesline MK, Subbiah V, Previs RA, et al. The impact of prior single‐gene testing on comprehensive genomic profiling results for patients with non‐small cell lung cancer. Oncol Ther 2024; 12: 329–343. PubMed PMC

Bayle A, Bonastre J, Chaltiel D, et al. ESMO study on the availability and accessibility of biomolecular technologies in oncology in Europe. Ann Oncol 2023; 34: 934–945. PubMed

Pinto C, Biffoni M, Popoli P, et al. Molecular tests and target therapies in oncology: recommendations from the Italian workshop. Future Oncol 2021; 17: 3529–3539. PubMed

Thunnissen E, Weynand B, Udovicic‐Gagula D, et al. Lung cancer biomarker testing: perspective from Europe. Transl Lung Cancer Res 2020; 9: 887–897. PubMed PMC

Hofman P, Calabrese F, Kern I, et al. Real‐world EGFR testing practices for non‐small‐cell lung cancer by thoracic pathology laboratories across Europe. ESMO Open 2023; 8: 101628. PubMed PMC

Horgan D, Hamdi Y, Lal JA, et al. Framework for adoption of next‐generation sequencing (NGS) globally in the oncology area. Healthcare 2023; 11: 431. PubMed PMC

Phillips KA, Douglas MP, Wordsworth S, et al. Availability and funding of clinical genomic sequencing globally. BMJ Glob Health 2021; 6: e004415. PubMed PMC

Ehman M, Punian J, Weymann D, et al. Next‐generation sequencing in oncology: challenges in economic evaluations. Expert Rev Pharmacoecon Outcomes Res 2024; 24: 1115–1132. PubMed

Arriola E, Bernabe R, Campelo RG, et al. Cost‐effectiveness of next‐generation sequencing versus single‐gene testing for the molecular diagnosis of patients with metastatic non‐small‐cell lung cancer from the perspective of Spanish reference centers. JCO Precis Oncol 2023; 7: e2200546. PubMed PMC

Lemmon CA, Zhou J, Hobbs B, et al. Modeling costs and life‐years gained by population‐wide next‐generation sequencing or single‐gene testing in nonsquamous non‐small‐cell lung cancer in the United States. JCO Precis Oncol 2023; 7: e2200294. PubMed PMC

Matsuda H, Ogawa T, Sadatsuki Y, et al. Budget impact analysis of next‐generation sequencing versus sequential single‐gene testing in Japanese patients with advanced non‐small‐cell lung cancer. Respir Investig 2023; 61: 61–73. PubMed

Pruneri G, De Braud F, Sapino A, et al. Next‐generation sequencing in clinical practice: is it a cost‐saving alternative to a single‐gene testing approach? Pharmacoecon Open 2021; 5: 285–298. PubMed PMC

Stenzinger A, Cuffel B, Paracha N, et al. Supporting biomarker‐driven therapies in oncology: a genomic testing cost calculator. Oncologist 2023; 28: e242–e253. PubMed PMC

Vanderpoel J, Stevens AL, Emond B, et al. Total cost of testing for genomic alterations associated with next‐generation sequencing versus polymerase chain reaction testing strategies among patients with metastatic non‐small cell lung cancer. J Med Econ 2022; 25: 457–468. PubMed

Krebs E, Weymann D, Ho C, et al. Real‐world cost‐effectiveness of multi‐gene panel sequencing to inform therapeutic decisions for advanced non‐small cell lung cancer: a population‐based study. Lancet Reg Health Am 2024; 40: 100936. PubMed PMC

Schluckebier L, Caetano R, Garay OU, et al. Cost‐effectiveness analysis comparing companion diagnostic tests for EGFR, ALK, and ROS1 versus next‐generation sequencing (NGS) in advanced adenocarcinoma lung cancer patients. BMC Cancer 2020; 20: 875. PubMed PMC

van Amerongen RA, Retel VP, Coupe VM, et al. Next‐generation sequencing in NSCLC and melanoma patients: a cost and budget impact analysis. Ecancermedicalscience 2016; 10: 684. PubMed PMC

Pisapia P, Pepe F, Baggi A, et al. Next generation diagnostic algorithm in non‐small cell lung cancer predictive molecular pathology: the KWAY Italian multicenter cost evaluation study. Crit Rev Oncol Hematol 2022; 169: 103525. PubMed

Mfumbilwa ZA, Simons M, Ramaekers B, et al. Exploring the cost effectiveness of a whole‐genome sequencing‐based biomarker for treatment selection in patients with advanced lung cancer ineligible for targeted therapy. Pharmacoeconomics 2024; 42: 419–434. PubMed PMC

Simons M, Retel VP, Ramaekers BLT, et al. Early cost effectiveness of whole‐genome sequencing as a clinical diagnostic test for patients with inoperable stage IIIB,C/IV non‐squamous non‐small‐cell lung cancer. Pharmacoeconomics 2021; 39: 1429–1442. PubMed PMC

Simons M, Uyl‐de Groot CA, Retel VP, et al. Cost‐effectiveness and budget impact of future developments with whole‐genome sequencing for patients with lung cancer. Value Health 2023; 26: 71–80. PubMed

Gordon LG, White NM, Elliott TM, et al. Estimating the costs of genomic sequencing in cancer control. BMC Health Serv Res 2020; 20: 492. PubMed PMC

Hamblin A, Wordsworth S, Fermont JM, et al. Clinical applicability and cost of a 46‐gene panel for genomic analysis of solid tumours: retrospective validation and prospective audit in the UK National Health Service. PLoS Med 2017; 14: e1002230. PubMed PMC

Kumar S, Bennett A, Campbell PA, et al. Costs of next‐generation sequencing assays in non‐small cell lung cancer: a micro‐costing study. Curr Oncol 2022; 29: 5238–5246. PubMed PMC

Tan AC, Lai GGY, Tan GS, et al. Utility of incorporating next‐generation sequencing (NGS) in an Asian non‐small cell lung cancer (NSCLC) population: incremental yield of actionable alterations and cost‐effectiveness analysis. Lung Cancer 2020; 139: 207–215. PubMed

de Jager VD, Timens W, Bayle A, et al. Future perspective for the application of predictive biomarker testing in advanced stage non‐small cell lung cancer. Lancet Reg Health Eur 2024; 38: 100839. PubMed PMC

Liu X, Deng J, Zhang R, et al. The clinical development of antibody‐drug conjugates for non‐small cell lung cancer therapy. Front Immunol 2023; 14: 1335252. PubMed PMC

Penault‐Llorca F, Kerr KM, Garrido P, et al. Expert opinion on NSCLC small specimen biomarker testing – part 2: analysis, reporting, and quality assessment. Virchows Arch 2022; 481: 351–366. PubMed PMC

Pezzuto F, Hofman V, Bontoux C, et al. The significance of co‐mutations in EGFR‐mutated non‐small cell lung cancer: optimizing the efficacy of targeted therapies? Lung Cancer 2023; 181: 107249. PubMed

Hynes SO, Pang B, James JA, et al. Tissue‐based next generation sequencing: application in a universal healthcare system. Br J Cancer 2017; 116: 553–560. PubMed PMC

Coquerelle S, Darlington M, Michel M, et al. Impact of next generation sequencing on clinical practice in oncology in France: better genetic profiles for patients improve access to experimental treatments. Value Health 2020; 23: 898–906. PubMed

Zou D, Ye W, Hess LM, et al. Diagnostic value and cost‐effectiveness of next‐generation sequencing‐based testing for treatment of patients with advanced/metastatic non‐squamous non‐small‐cell lung cancer in the United States. J Mol Diagn 2022; 24: 901–914. PubMed

Loong HH, Shimizu T, Prawira A, et al. Recommendations for the use of next‐generation sequencing in patients with metastatic cancer in the Asia‐Pacific region: a report from the APODDC working group. ESMO Open 2023; 8: 101586. PubMed PMC

World Medical Association . WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. [Accessed 13 January 2025]. Available from: https://www.wma.net/policies‐post/wma‐declaration‐of‐helsinki‐ethical‐principles‐for‐medical‐research‐involving‐human‐subjects

Schwarze K, Buchanan J, Fermont JM, et al. The complete costs of genome sequencing: a microcosting study in cancer and rare diseases from a single center in the United Kingdom. Genet Med 2020; 22: 85–94. PubMed PMC

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