title: A cost-effectiveness and budget impact analysis of first-line fidaxomicin for patients with Clostridium difficile infection (CDI) in Germany.
abstract: OBJECTIVE
  Clostridium difficile infection (CDI) represents a significant economic healthcare burden, especially the cost of recurrent disease. Fidaxomicin produced significantly lower recurrence rates and higher sustained cure rates in clinical trials. We evaluated the cost-effectiveness and budget impact of fidaxomicin compared with vancomycin in Germany in the first-line treatment of patient subgroups with CDI at increased risk of recurrence.
  
  
  METHODS
  A semi-Markov model was used to compare the cost-effectiveness and budget impact of fidaxomicin vs. vancomycin from a payer perspective in Germany. The model cycle length was 10 days. The time horizon was 1 year. Model inputs were probability of clinical cure, 30-day probability of recurrence, and 30-day attributable mortality based on evidence from two randomized controlled trials comparing fidaxomicin and vancomycin in patients with CDI. Cost-effectiveness outcomes were cost per quality-adjusted life year gained, cost per bed-day saved, and cost per recurrence avoided.
  
  
  RESULTS
  Despite higher drug acquisition costs, fidaxomicin was dominant in the cancer subgroup (less costly and more effective) and cost-effective in the other subgroups, with incremental cost-effectiveness ratios vs. vancomycin ranging from €26,900 to €44,500. Hospitalization costs of the first-line treatment of CDI with fidaxomicin vs. vancomycin were lower in every patient subgroup, resulting in budget impacts ranging from -€1325 (in patients ≥65 years) to -€2438 (in cancer patients). Reductions in the cost of treating recurrence with fidaxomicin ranged from -€574.32 per patient in those receiving concomitant antibiotics to -€1500.68 per patient in renally impaired patients.
  
  
  CONCLUSIONS
  In patient subgroups with CDI at increased recurrence risk, fidaxomicin was cost-effective vs. vancomycin, and less costly and more effective in patients with cancer.
authors.affiliation: Astellas EMEA, Chertsey, UK. maureen.watt@astellas.com.|Astellas Pharma Europe Ltd., 2000 Hillswood Drive, Chertsey, KT16 0RS, UK. maureen.watt@astellas.com.
authors.forename: Maureen
authors.initials: M
authors.lastname: Watt
authors.affiliation: PAREXEL Access Consulting, London, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: McCrea
authors.affiliation: PAREXEL Access Consulting, London, UK.
authors.forename: Sukhvinder
authors.initials: S
authors.lastname: Johal
authors.affiliation: PAREXEL Access Consulting, London, UK.
authors.forename: John
authors.initials: J
authors.lastname: Posnett
authors.affiliation: Astellas EMEA, Chertsey, UK.
authors.forename: Jameel
authors.initials: J
authors.lastname: Nazir
mesh_terms: D000617:Aminoglycosides / Q000191:economics* / Q000494:pharmacology / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000191:economics / Q000494:pharmacology / Q000627:therapeutic use; D016360:Clostridioides difficile / Q000187:drug effects; D003362:Cost-Benefit Analysis; D004761:Enterocolitis, Pseudomembranous / Q000188:drug therapy* / Q000191:economics; D000077732:Fidaxomicin; D005858:Germany; D006801:Humans; D008390:Markov Chains; D012008:Recurrence
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077732:Fidaxomicin
keywords: Budget impact; Clostridium difficile; Cost-effectiveness; Fidaxomicin; Vancomycin