title: Budget impact analysis of the use of oral and intravenous anti-cancer drugs for the treatment of HER2-positive metastatic breast cancer.
abstract: OBJECTIVE
  Two anti-cancer drugs are currently approved for the treatment of HER2-positive metastatic breast cancer (MBC): trastuzumab-based therapy (TBT) administered intravenously as first line therapy until disease progression and lapatinib, an oral self-administered dual therapy with capecitabine (L+C) as second intention for patients who continue to progress despite TBT. In current practice, TBT is still prescribed beyond disease progression. In addition to medical reasons, the difficulty to switch eligible patients to oral drugs may also be explained by economic reasons. Thus, we aimed at comparing the budgetary impact of TBT and L+C for progressing HER2+MBC after TBT from the French Health Insurance perspective.
  
  
  METHODS
  A budget impact analysis was performed on a 3-year time horizon (2012-2014) to simulate a dynamic cohort of 4182 HER2-positive patients with a progressing MBC treated with TBT (73%) and L + C (27%). The model was adjusted on progression-free survival (PFS). Office visits, clinical evaluations, drug acquisition, administration costs, and transportation costs obtained from the literature and published databases were considered.
  
  
  RESULTS
  In the base case analysis (2012), the annual treatment cost per patient for TBT (€36,077) was 2-times higher than that of L + C (€17,165). Using L + C for all patients (n = 4182) would avoid €34.8 million of drug administration and transportation costs. Hospital costs represented 1% vs 88%, while community costs represented 99% vs 12% of L + C and TBT treatment costs, respectively. The lack of direct comparison PFS and treatment dosage modification data were the main limitations. However, no major changes from baseline results were observed from sensitivity analyses.
  
  
  CONCLUSIONS
  Despite a slightly higher acquisition cost, the treatment cost of L + C remains lower than that of TBT, and it is the only approved anti-HER2 treatment for HER2-positive patients with progressing MBC. Based on this, it seems important to consider the potential savings for Health Insurance with the use of oral drug due to the reduction of outpatient hospitalizations. Such reductions may result in a subsequent budget reduction for hospitals, but may also provide those facing acute medical activity with opportunities to better manage other diseases whose treatment cannot be externalized.
authors.affiliation: Epidémiologie, évaluation et politiques de santé, Université Paris Descartes, Sorbonne Paris Cité, France. laure.l.benjamin@gsk.com
authors.forename: Laure
authors.initials: L
authors.lastname: Benjamin
authors.forename: Valérie
authors.initials: V
authors.lastname: Buthion
authors.forename: Michaël
authors.initials: M
authors.lastname: Iskedjian
authors.forename: Bechara
authors.initials: B
authors.lastname: Farah
authors.forename: Catherine
authors.initials: C
authors.lastname: Rioufol
authors.forename: Gwenaëlle
authors.initials: G
authors.lastname: Vidal-Trécan
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000191:economics / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality; D000069287:Capecitabine; D003365:Costs and Cost Analysis; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D005602:France; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D000077341:Lapatinib; D008875:Middle Aged; D017059:Models, Econometric; D009362:Neoplasm Metastasis; D011799:Quinazolines / Q000191:economics / Q000627:therapeutic use; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D000077341:Lapatinib; D011799:Quinazolines; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab