title: Cost-effectiveness analysis of trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2): positive advanced breast cancer.
abstract: OBJECTIVE
  The EMILIA trial demonstrated that trastuzumab emtansine (T-DM1) significantly increased the median profession-free and overall survival relative to combination therapy with lapatinib plus capecitabine (LC) in patients with HER2-positive advanced breast cancer (ABC) previously treated with trastuzumab and a taxane. We performed an economic analysis of T-DM1 as a second-line therapy compared to LC and monotherapy with capecitabine (C) from both perspectives of the US payer and society.
  
  
  METHODS
  We developed four possible Markov models for ABC to compare the projected life-time costs and outcomes of T-DM1, LC, and C. Model transition probabilities were estimated from the EMILIA and EGF100151 clinical trials. Direct costs of the therapies, major adverse events, laboratory tests, and disease progression, indirect costs (productivity losses due to morbidity and mortality), and health utilities were obtained from published sources. The models used 3 % discount rate and reported in 2015 US dollars. Probabilistic sensitivity analysis and model averaging were used to account for model parametric and structural uncertainty.
  
  
  RESULTS
  When incorporating both model parametric and structural uncertainty, the resulting incremental cost-effectiveness ratios (ICER) comparing T-DM1 to LC and T-DM1 to C were $183,828 per quality-adjusted life year (QALY) and $126,001/QALY from the societal perspective, respectively. From the payer's perspective, the ICERs were $220,385/QALY (T-DM1 vs. LC) and $168,355/QALY (T-DM1 vs. C).
  
  
  CONCLUSIONS
  From both perspectives of the US payer and society, T-DM1 is not cost-effective when comparing to the LC combination therapy at a willingness-to-pay threshold of $150,000/QALY. T-DM1 might have a better chance to be cost-effective compared to capecitabine monotherapy from the US societal perspective.
authors: Western University of Health Sciences, College of Pharmacy, 302 E. Second Street, Pomona, CA, 91766-1854, USA. qle@westernu.edu.
authors: Quang A
authors: QA
authors: Le
authors: Western University of Health Sciences, College of Pharmacy, 302 E. Second Street, Pomona, CA, 91766-1854, USA.
authors: Yuna H
authors: YH
authors: Bae
authors: Western University of Health Sciences, College of Pharmacy, 302 E. Second Street, Pomona, CA, 91766-1854, USA.
authors: Jenny H
authors: JH
authors: Kang
mesh_terms: D000080044:Ado-Trastuzumab Emtansine; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics; D000069287:Capecitabine / Q000191:economics* / Q000627:therapeutic use; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D000077341:Lapatinib; D008390:Markov Chains; D008453:Maytansine / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D008875:Middle Aged; D019057:Quality-Adjusted Life Years; D011799:Quinazolines / Q000191:economics* / Q000627:therapeutic use; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D000068878:Trastuzumab / Q000191:economics* / Q000627:therapeutic use; D016896:Treatment Outcome; D014481:United States
chemical_list: D000080044:Ado-Trastuzumab Emtansine; D000069287:Capecitabine; D000077341:Lapatinib; D008453:Maytansine; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Cost-effectiveness analysis; HER2-positive advanced breast cancer; Kadcyla; T-DM1; Trastuzumab emtansine