Clinical and economic impact of 'ROS1-testing' strategy compared to a 'no-ROS1-testing' strategy in advanced NSCLC in Spain.
Biomarkers, Tumor
/ genetics
Biopsy
/ economics
Carcinoma, Non-Small-Cell Lung
/ economics
Cost-Benefit Analysis
Female
Gene Rearrangement
Humans
Lung Neoplasms
/ economics
Male
Molecular Diagnostic Techniques
/ economics
Protein-Tyrosine Kinases
/ metabolism
Proto-Oncogene Proteins
/ metabolism
Quality-Adjusted Life Years
Spain
Biomarker guided selection
C-ros oncogene 1
Cost-effectiveness analysis
Molecular testing
Non-small cell lung cancer
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
19 Mar 2022
19 Mar 2022
Historique:
received:
22
11
2021
accepted:
08
03
2022
entrez:
19
3
2022
pubmed:
20
3
2022
medline:
25
3
2022
Statut:
epublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 35303812
doi: 10.1186/s12885-022-09397-4
pii: 10.1186/s12885-022-09397-4
pmc: PMC8933896
doi:
Substances chimiques
Biomarkers, Tumor
0
Proto-Oncogene Proteins
0
Protein-Tyrosine Kinases
EC 2.7.10.1
ROS1 protein, human
EC 2.7.10.1
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
292Informations de copyright
© 2022. The Author(s).
Références
BMC Cancer. 2021 Jun 10;21(1):689
pubmed: 34112097
Lancet Oncol. 2017 Nov;18(11):1454-1466
pubmed: 28958502
Clin Transl Oncol. 2015 Feb;17(2):103-12
pubmed: 25351175
N Engl J Med. 2018 Jan 11;378(2):113-125
pubmed: 29151359
Breast Cancer Res Treat. 2016 Jan;155(2):223-34
pubmed: 26749360
J Thorac Oncol. 2018 Oct;13(10):1474-1482
pubmed: 29935306
Pharmacoeconomics. 2018 Apr;36(4):495-504
pubmed: 29488070
J Thorac Oncol. 2014 Dec;9(12):1816-20
pubmed: 25393795
J Clin Oncol. 2021 Jul 20;39(21):2339-2349
pubmed: 33872070
N Engl J Med. 2018 Jun 14;378(24):2288-2301
pubmed: 29863955
Lung Cancer. 2019 Jan;127:44-52
pubmed: 30642550
Clin Transl Oncol. 2015 Sep;17(9):702-9
pubmed: 25990507
Discov Med. 2019 Mar;27(148):167-170
pubmed: 31095926
Curr Oncol. 2021 Aug 25;28(5):3268-3279
pubmed: 34449580
ESMO Open. 2020 Nov;5(6):e001021
pubmed: 33214227
Diagnostics (Basel). 2016 Jan 06;6(1):
pubmed: 26838801
N Engl J Med. 2006 Dec 14;355(24):2542-50
pubmed: 17167137
BMC Cancer. 2020 Sep 14;20(1):875
pubmed: 32928143
J Thorac Oncol. 2021 Feb;16(2):197-204
pubmed: 33109473
Cancer. 2019 Mar 15;125(6):892-901
pubmed: 30512189
Ann Oncol. 2020 Aug;31(8):1056-1064
pubmed: 32418886
J Thorac Oncol. 2016 Jul;11(7):1140-52
pubmed: 27094798
J Clin Oncol. 2018 May 10;36(14):1405-1411
pubmed: 29596029
Ann Oncol. 2018 Jun 1;29(6):1409-1416
pubmed: 29668860
Pharmacoeconomics. 2000 May;17(5):479-500
pubmed: 10977389
Clin Lung Cancer. 2017 Jan;18(1):60-67
pubmed: 27919627
J Clin Pathol. 2022 Mar;75(3):193-200
pubmed: 33722840
N Engl J Med. 2016 Nov 10;375(19):1823-1833
pubmed: 27718847
Lancet. 2021 Aug 7;398(10299):535-554
pubmed: 34273294
N Engl J Med. 2020 Jan 2;382(1):41-50
pubmed: 31751012
Clin Chem. 2017 Mar;63(3):751-760
pubmed: 28073897
Expert Rev Mol Diagn. 2021 May;21(5):437-444
pubmed: 33899645
Gac Sanit. 2010 Mar-Apr;24(2):154-70
pubmed: 19959258
Discov Med. 2018 Oct;26(143):155-166
pubmed: 30586539
Gac Sanit. 2020 Mar - Apr;34(2):189-193
pubmed: 31558385
Arch Pathol Lab Med. 2018 Mar;142(3):321-346
pubmed: 29355391
Transl Lung Cancer Res. 2019 Aug;8(4):461-475
pubmed: 31555519
Health Econ. 2018 Apr;27(4):746-761
pubmed: 29282798
Ann Oncol. 2018 Oct 1;29(Suppl 4):iv192-iv237
pubmed: 30285222
Lung Cancer. 2021 Apr;154:161-175
pubmed: 33690091
J Thorac Oncol. 2019 Dec;14(12):2120-2132
pubmed: 31349061
BMJ Open. 2019 Dec 11;9(12):e031019
pubmed: 31831534
J Clin Pathol. 2022 Mar;75(3):145-153
pubmed: 33875457
J Clin Oncol. 2020 May 10;38(14):1505-1517
pubmed: 32150489
Clin Transl Oncol. 2020 Jul;22(7):989-1003
pubmed: 31598903
Oncotarget. 2016 Nov 15;7(46):75145-75154
pubmed: 27738334
Cancer Med. 2016 Oct;5(10):2688-2693
pubmed: 27544536
Ann Oncol. 2019 Jul 1;30(7):1121-1126
pubmed: 30980071
Lung Cancer (Auckl). 2017 Jul 07;8:45-55
pubmed: 28740441