Fabienne Englmeier1, Annalen Bleckmann2,3, Wolfgang Brückl4, Frank Griesinger5, Annette Fleitz6, Klaus Nagels7. 1. Chair of Healthcare Management and Health Services Research, University of Bayreuth, Parsifalstraße 25, 95445, Bayreuth, Germany. 2. Medical Clinic A, Haematology, Haemostaseology, Oncology and Pulmonology, University Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany. 3. Department of Haematology and Medical Oncology, University of Medicine Goettingen, Robert-Koch-Straße 40, 37075, Göttingen, Germany. 4. Department of Respiratory Medicine, Allergology and Sleep Medicine, Nuremberg Lung Cancer Center, General Hospital Nuremberg, Paracelsus Medical University, Prof.-Ernst-Nathan-Straße 1, 90419, Nuremberg, Germany. 5. Pius-Hospital Oldenburg, University Clinic Internal Medicine, Georgstraße 12, 26121, Oldenburg, Germany. 6. Clinical Epidemiology and Health Economics, iOMEDICO, Ellen-Gottlieb-Straße 19, 79108, Freiburg, Germany. 7. Chair of Healthcare Management and Health Services Research, University of Bayreuth, Parsifalstraße 25, 95445, Bayreuth, Germany. klaus.nagels@uni-bayreuth.de.
Abstract
PURPOSE: Targeted therapies are effective therapeutic approaches in advanced stages of NSCLC and require precise molecular profiling to identify oncogenic drivers. Differential diagnosis on a molecular level contributes to clinical decision making. Liquid biopsy (LB) use has demonstrated its potential to serve as an alternative to tissue biopsy (TB) particularly in cases where tissue sampling is not feasible or insufficient. We aimed at evaluating the cost-effectiveness of ctDNA-based LB use (molecular multigene testing) according to German care guidelines for metastatic NSCLC. METHODS: A Markov model was developed to compare the costs and clinical benefits associated with the use of LB as an add-on to TB according to the guidelines for NSCLC patients. Usual care TB served as comparator. A microsimulation model was used to simulate a cohort of non-squamous NSCLC patients stage IV. The parameters used for modelling were obtained from the literature and from the prospective German CRISP registry ("Clinical Research platform Into molecular testing, treatment, and outcome of non-Small cell lung carcinoma Patients"). For each pathway, average direct medical costs, and QALYs gained per patient were used for calculating incremental cost-effectiveness ratios (ICER). RESULTS: The use of LB as an add-on was costlier (€144,981 vs. €144,587) but more effective measured in QALYs (1.20 vs. 1.19) for the care pathway of NSCLC patients (ICER €53,909/QALY). Cost-effectiveness was shown for EGFR-mutated patients (ICER €-13,247/QALY). CONCLUSION: Including LB as an add-on into the care pathway of advanced NSCLC has positive clinical effects in terms of QALYs accompanied by a moderate cost-effectiveness.
PURPOSE: Targeted therapies are effective therapeutic approaches in advanced stages of NSCLC and require precise molecular profiling to identify oncogenic drivers. Differential diagnosis on a molecular level contributes to clinical decision making. Liquid biopsy (LB) use has demonstrated its potential to serve as an alternative to tissue biopsy (TB) particularly in cases where tissue sampling is not feasible or insufficient. We aimed at evaluating the cost-effectiveness of ctDNA-based LB use (molecular multigene testing) according to German care guidelines for metastatic NSCLC. METHODS: A Markov model was developed to compare the costs and clinical benefits associated with the use of LB as an add-on to TB according to the guidelines for NSCLC patients. Usual care TB served as comparator. A microsimulation model was used to simulate a cohort of non-squamous NSCLC patients stage IV. The parameters used for modelling were obtained from the literature and from the prospective German CRISP registry ("Clinical Research platform Into molecular testing, treatment, and outcome of non-Small cell lung carcinoma Patients"). For each pathway, average direct medical costs, and QALYs gained per patient were used for calculating incremental cost-effectiveness ratios (ICER). RESULTS: The use of LB as an add-on was costlier (€144,981 vs. €144,587) but more effective measured in QALYs (1.20 vs. 1.19) for the care pathway of NSCLC patients (ICER €53,909/QALY). Cost-effectiveness was shown for EGFR-mutated patients (ICER €-13,247/QALY). CONCLUSION: Including LB as an add-on into the care pathway of advanced NSCLC has positive clinical effects in terms of QALYs accompanied by a moderate cost-effectiveness.
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