title: Cost-Effectiveness of an Individualized First-Line Treatment Strategy Offering Erlotinib Based on EGFR Mutation Testing in Advanced Lung Adenocarcinoma Patients in Germany.
abstract: BACKGROUND
  Lung cancer is among the top causes of cancer-related deaths. Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors can increase progression-free survival compared with standard chemotherapy in patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC).
  
  
  OBJECTIVE
  The aim of the study was to evaluate the cost-effectiveness of EGFR mutation analysis and first-line therapy with erlotinib for mutation-positive patients compared with non-individualized standard chemotherapy from the perspective of German statutory health insurance.
  
  
  METHODS
  A state transition model was developed for a time horizon of 10 years (reference year 2014). Data sources were published data from the European Tarceva versus Chemotherapy (EURTAC) randomized trial for drug efficacy and safety and German cost data. We additionally performed deterministic, probabilistic and structural sensitivity analyses.
  
  
  RESULTS
  The individualized strategy incurred 0.013 additional quality-adjusted life-years (QALYs) and additional costs of € 200, yielding an incremental cost-effectiveness ratio (ICER) of € 15,577/QALY. Results were most sensitive to uncertainty in survival curves and changes in utility values. Cross-validating health utility estimates with recent German data increased the ICER to about € 58,000/QALY. The probabilistic sensitivity analysis indicated that the individualized strategy is cost-effective, with a probability exceeding 50 % for a range of possible willingness-to-pay thresholds.
  
  
  CONCLUSIONS
  The uncertainty of the predicted survival curves is substantial, particularly for overall survival, which was not a primary endpoint in the EURTAC study. Also, there is limited data on quality of life in metastatic lung cancer patients.
  
  
  CONCLUSIONS
  Individualized therapy based on EGFR mutation status has the potential to provide a cost-effective alternative to non-individualized care for patients with advanced adenocarcinoma. Further clinical research is needed to confirm these results.
authors.affiliation: Helmholtz Zentrum München (GmbH), German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (CPC-M), Ingolstädter Landstraße 1, 85758, Neuherberg, Germany. katharina.schremser@helmholtz-muenchen.de.
authors.forename: Katharina
authors.initials: K
authors.lastname: Schremser
authors.affiliation: Helmholtz Zentrum München (GmbH), German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (CPC-M), Ingolstädter Landstraße 1, 85758, Neuherberg, Germany.|Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Clinical Center, University of Munich, Munich, Germany.
authors.forename: Wolf H
authors.initials: WH
authors.lastname: Rogowski
authors.affiliation: Division of Hematology and Oncology, Medical Clinic and Policlinic IV, University of Munich, Munich, Germany.
authors.forename: Sigrid
authors.initials: S
authors.lastname: Adler-Reichel
authors.affiliation: Division of Respiratory Medicine and Thoracic Oncology, Medical Clinic and Policlinic V, Thoracic Oncology Centre Munich, University of Munich, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (CPC-M), Munich, Germany.
authors.forename: Amanda L H
authors.initials: AL
authors.lastname: Tufman
authors.affiliation: Division of Respiratory Medicine and Thoracic Oncology, Medical Clinic and Policlinic V, Thoracic Oncology Centre Munich, University of Munich, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (CPC-M), Munich, Germany.
authors.forename: Rudolf M
authors.initials: RM
authors.lastname: Huber
authors.affiliation: Helmholtz Zentrum München (GmbH), German Research Center for Environmental Health (GmbH), Institute of Health Economics and Health Care Management, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (CPC-M), Ingolstädter Landstraße 1, 85758, Neuherberg, Germany.
authors.forename: Björn
authors.initials: B
authors.lastname: Stollenwerk
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000191:economics* / Q000235:genetics / Q000401:mortality; D000077192:Adenocarcinoma of Lung; D003362:Cost-Benefit Analysis; D004252:DNA Mutational Analysis / Q000191:economics*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000235:genetics*; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D005858:Germany; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000191:economics* / Q000235:genetics / Q000401:mortality; D018803:Models, Economic; D009154:Mutation; D009361:Neoplasm Invasiveness; D057285:Precision Medicine / Q000191:economics*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
chemical_list: D047428:Protein Kinase Inhibitors; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors