title: Economic evaluation of antifungal agents in the treatment of toenail onychomycosis in Germany.
abstract: BACKGROUND
  The strategies for the management of onychomycosis have changed since the availability of the newer generation of antifungal agents, particularly, itraconazole and terbinafine. Itraconazole (1-week pulse) therapy may have higher efficacy and an improved adverse-effects profile compared to the continuous therapy regimen.
  
  
  OBJECTIVE
  We performed a pharmacoeconomic evaluation of the most commonly used treatments in Germany for toenail onychomycosis from a health care payer perspective.
  
  
  METHODS
  A 5-step approach was used. Firstly, the purpose of the study, the comparator drugs, their dosage regimens and the time frame of the analysis were defined. Next, the medical practice and resource consumption patterns associated with the treatment of onychomycosis were identified. In step III, a meta-analysis was used to determine the relative efficacy of the comparator drugs. In step IV, a decision tree of the treatment algorithms was constructed for each comparator. The expected cost analysis and cost-effectiveness analysis were also performed. Finally, a sensitivity analysis was carried out.
  
  
  RESULTS
  For the four main comparator drugs used to treat toenail onychomycosis in Germany, the clinical response rates (clinical cure plus marked improvement) at the end of the follow-up period (month 12 after starting therapy) were, for itraconazole (1-week pulse dosing): 89.8 +/- 3% (mean +/- SE), terbinafine: 79.4 +/- 10%, itraconazole (continuous dosing): 77.5 +/- 9%, and ciclopirox nail varnish: 55 +/- 5%. Itraconazole (1-week pulse dosing) was most cost-effective at DM 1,107 per successful treatment, followed by oral terbinafine at DM 1,224, ciclopirox nail varnish and itraconazole (continuous dosing). Sensitivity analyses indicated that itraconazole (1-week pulse dosing) and terbinafine had similar cost-effectiveness ratios.
  
  
  CONCLUSIONS
  Itraconazole is an effective, broad-spectrum triazole used as continuous or pulse therapy in the treatment of onychomycosis. Itraconazole (1-week pulse) and terbinafine are the most cost-effective therapies for toenail onychomycosis.
authors.affiliation: Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands.
authors.forename: E K
authors.initials: EK
authors.lastname: Van Doorslaer
authors.forename: G
authors.initials: G
authors.lastname: Tormans
authors.forename: A K
authors.initials: AK
authors.lastname: Gupta
authors.forename: K
authors.initials: K
authors.lastname: Van Rossem
authors.forename: A
authors.initials: A
authors.lastname: Eggleston
authors.forename: D J
authors.initials: DJ
authors.lastname: Dubois
authors.forename: P
authors.initials: P
authors.lastname: De Doncker
authors.forename: E
authors.initials: E
authors.lastname: Haneke
mesh_terms: D000465:Algorithms; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D000077768:Ciclopirox; D003362:Cost-Benefit Analysis; D003365:Costs and Cost Analysis; D003663:Decision Trees; D004334:Drug Administration Schedule; D016527:Drug Costs; D005069:Evaluation Studies as Topic; D005500:Follow-Up Studies; D005533:Foot Dermatoses / Q000188:drug therapy; D005858:Germany; D006295:Health Resources; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D015201:Meta-Analysis as Topic; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D014009:Onychomycosis / Q000188:drug therapy*; D010150:Paint; D010818:Practice Patterns, Physicians'; D011728:Pyridones / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D012680:Sensitivity and Specificity; D000077291:Terbinafine
chemical_list: D000935:Antifungal Agents; D009281:Naphthalenes; D011728:Pyridones; D000077768:Ciclopirox; D017964:Itraconazole; D000077291:Terbinafine