title: Human epidermal growth factor receptor 2 expression in early breast cancer patients: a Swiss cost-effectiveness analysis of different predictive assay strategies.
abstract: Trastuzumab has conferred significant clinical benefits in HER-2-positive breast carcinomas. HER-2 status is determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridisation (FISH), but appropriate assessment of HER2 status remains subject to considerable debate. Data on the health economic impact of HER-2 test strategies are limited. A life-long Markov state transition model was used to assess costs and effectiveness of HER-2 assay strategies (based on IHC, FISH, both combined or FISH confirmation of IHC2+) for a hypothetical cohort of early breast cancer patients from the perspective of the Swiss health system. We compared clinically relevant strategies of predictive testing and subsequent trastuzumab treatment of HER-2-positive patients only. FISH testing was the most cost-effective strategy with an incremental cost-effectiveness ratio of €12,245 per additional quality-adjusted life-year (QALY) gained, compared to no trastuzumab treatment. The next best strategy was parallel IHC and FISH, with costs of €400,154/QALY gained compared to FISH alone. FISH as primary HER-2 testing modality remained the preferred option in deterministic and probabilistic sensitivity analysis. Predictive testing to identify adjuvant breast cancer patients who benefit from trastuzumab treatment is a clinical and economic necessity. Our model identifies FISH as the most cost-effective approach.
authors.affiliation: Institute of Social and Preventive Medicine, University of Zurich, Hirschengraben 84, 8001, Zurich, Switzerland. patricia.blank@ifspm.uzh.ch
authors.forename: Patricia R
authors.initials: PR
authors.lastname: Blank
authors.forename: Matthias
authors.initials: M
authors.lastname: Schwenkglenks
authors.forename: Holger
authors.initials: H
authors.lastname: Moch
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Szucs
mesh_terms: D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000032:analysis* / Q000235:genetics; D001943:Breast Neoplasms / Q000737:chemistry* / Q000188:drug therapy / Q000235:genetics / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007150:Immunohistochemistry / Q000191:economics*; D017404:In Situ Hybridization, Fluorescence / Q000191:economics*; D008390:Markov Chains; D008403:Mass Screening / Q000191:economics* / Q000379:methods; D018803:Models, Economic; D009313:National Health Programs / Q000191:economics*; D011237:Predictive Value of Tests; D019057:Quality-Adjusted Life Years; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis* / Q000235:genetics; D012680:Sensitivity and Specificity; D013557:Switzerland; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human