title: Cost-effectiveness analysis on the use of fidaxomicin and vancomycin to treat Clostridium difficile infection in France.
abstract: BACKGROUND
  Fidaxomicin is a macrocyclic antibiotic with proven efficacy against Clostridium difficile infection (CDI) in adults. It was licensed in France in 2012, but, due to higher acquisition costs compared with existing treatments, healthcare providers require information on its cost/benefit profile.
  
  
  OBJECTIVE
  To compare healthcare costs and health outcomes of fidaxomicin and vancomycin, as reference treatment for CDI.
  
  
  METHODS
  A Markov model was used to simulate the treatment pathway, over 1 year, of adult patients with CDI receiving fidaxomicin or vancomycin. Several patient sub-groups (severe CDI; recurrent CDI; concomitant antibiotics; cancer; renal failure; elderly) were evaluated. Cost-effectiveness was analyzed based on cure and recurrence rates derived from published randomized clinical trials comparing fidaxomicin and vancomycin, and costs calculated from the payer perspective using French hospitalization data and drug cost databases. Model outputs included costs in euros (reference year 2014) and health outcomes (recurrence; sustained cure rates). Alternative scenario and sensitivity analyses were performed using data from other clinical trials in CDI, including one conducted in real-life clinical practice in France.
  
  
  RESULTS
  Drug acquisition costs were €1,692 higher in fidaxomicin-treated patients, but this was offset by the lower hospitalization costs with fidaxomicin, which were reduced by €1,722. The reduction in the cost of hospitalization was driven by the significantly lower number of recurrences in fidaxomicin-treated patients, offsetting the acquisition cost of fidaxomicin in all sub-groups except recurrent CDI and concomitant antibiotics.
  
  
  CONCLUSIONS
  This study demonstrated that, despite higher acquisition costs, the lower recurrence rate with fidaxomicin resulted in cost savings or low incremental costs compared with vancomycin.
authors.affiliation: a Health Economics and Outcomes Research, Astellas Pharma EMEA , Chertsey , UK.
authors.forename: Maureen
authors.initials: M
authors.lastname: Watt
authors.affiliation: b Département de Médecine Aiguë Spécialisée , Hopital Raymond Poincaré , Garches , France.
authors.forename: Aurélien
authors.initials: A
authors.lastname: Dinh
authors.affiliation: c Microbiologie Clinique, Groupe Hospitalier Paris Saint-Joseph , Paris , France.
authors.forename: Alban
authors.initials: A
authors.lastname: Le Monnier
authors.affiliation: d Pharmacie à Usage Intérieur, Groupe Hospitalier Pitié-Salpêtrière AP-HP , Paris , France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Tilleul
mesh_terms: D000367:Age Factors; D000617:Aminoglycosides / Q000191:economics* / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000191:economics* / Q000627:therapeutic use; D003015:Clostridium Infections / Q000188:drug therapy* / Q000453:epidemiology; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D000077732:Fidaxomicin; D005602:France / Q000453:epidemiology; D006760:Hospitalization / Q000191:economics; D006801:Humans; D008390:Markov Chains; D018803:Models, Economic; D009369:Neoplasms / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D051437:Renal Insufficiency / Q000453:epidemiology; D012720:Severity of Illness Index; D014640:Vancomycin / Q000191:economics* / Q000627:therapeutic use
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D014640:Vancomycin; D000077732:Fidaxomicin
keywords: Clostridium difficile; France; cost-effectiveness; fidaxomicin; vancomycin