title: Pharmacoeconomic analysis of ciclopirox nail lacquer solution 8% and the new oral antifungal agents used to treat dermatophyte toe onychomycosis in the United States.
abstract: BACKGROUND
  Recently a novel topical nail lacquer, ciclopirox solution 8%, has been approved for the treatment of onychomycosis.
  
  
  OBJECTIVE
  This was undertaken to determine the most cost-effective treatment for the treatment of dermatophyte onychomycosis of the toes in the United States in 2000.
  
  
  METHODS
  The nature of the problem was defined. The drug comparators were ciclopirox nail lacquer, terbinafine, itraconazole (pulse), itraconazole (continuous), fluconazole, and griseofulvin. A decision analytic model that reflected the manner in which pedal tinea unguium is managed was produced. Studies that have evaluated the efficacy of the nail lacquer and the oral antifungal agents for this indication were identified. Appropriate studies were used in a meta-analysis to determine the mycologic and clinical response rates when the drug comparators are used for the treatment for toe dermatophyte onychomycosis. For each drug comparator a cost of regimen analysis was carried out. This is the sum of the drug acquisition cost, the cost of medical management, and the cost of managing adverse effects. Next, the expected cost of management was calculated, disease free days were determined, and a sensitivity analysis was conducted.
  
  
  RESULTS
  For each comparator the meta-analytic average mycologic cure (MC) rate and clinical response (CR) rates were: ciclopirox nail lacquer (MC: 52.6 +/- 4.2%, CR: 52.4 +/- 9.0%), griseofulvin (MC: 41.1 +/- 20.4%, CR: 33.7 +/- 14.1%), itraconazole (continuous) (MC: 66.3 +/- 4.2%, CR: 70.3 +/- 4.2%), itraconazole (pulse) (MC: 70.8 +/- 5.7%, CR: 73.6 +/- 4.6%), terbinafine (MC: 77.2 +/- 4.0%, CR: 75.3 +/- 2.9%), and fluconazole (MC: 65.6 +/- 7.1%, CR: 66.5 +/- 11.7%). The cost of regimen for the drug comparators was: ciclopirox nail lacquer $325.2, griseofulvin $1413.1, itraconazole (continuous) $1410.2, itraconazole (pulse) $811.7, terbinafine $890.1, and fluconazole $966.8. The cost/mycologic cure rate and expected cost/expected symptom free day were, ciclopirox nail lacquer ($618.2, 1.69), griseofulvin $3438.2, 5.3), itraconazole (continuous) ($2126.9, 3.52), itraconazole (pulse) ($1146.4, 2.01), terbinafine ($1153.0, 2.14), and fluconazole ($1473.7, 2.10). The relative cost-effectiveness was ciclopirox nail lacquer 1.00, itraconazole (pulse) 1.19, fluconazole 1.24, terbinafine 1.27, itraconazole (continuous) 2.08, and griseofulvin 3.13. Sensitivity analysis indicated that ciclopirox nail lacquer was a cost effective alternative compared with the oral regimens of terbinafine, itraconazole (continuous), and griseofulvin when clinical response rate was used as the primary efficacy parameter.
  
  
  CONCLUSIONS
  Ciclopirox nail lacquer solution 8% is a recent addition to the armamentarium of therapies available to the physician and patient for the treatment of onychomycosis. The nail lacquer is a cost effective agent compared with the oral antifungal therapies, terbinafine, itraconazole, fluconazole, and griseofulvin.
authors.affiliation: Department of Medicine, Sunnybrook and Women's College Health Sciences Center, and University of Toronto, Ontario, Canada.
authors.forename: A K
authors.initials: AK
authors.lastname: Gupta
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000935:Antifungal Agents / Q000191:economics* / Q000627:therapeutic use; D003883:Arthrodermataceae / Q000187:drug effects*; D000077768:Ciclopirox; D003365:Costs and Cost Analysis; D016527:Drug Costs; D017850:Economics, Pharmaceutical; D005260:Female; D015725:Fluconazole / Q000191:economics / Q000627:therapeutic use; D005533:Foot Dermatoses / Q000188:drug therapy* / Q000191:economics; D006118:Griseofulvin / Q000191:economics / Q000627:therapeutic use; D006801:Humans; D017964:Itraconazole / Q000191:economics / Q000627:therapeutic use; D008297:Male; D018803:Models, Economic; D009281:Naphthalenes / Q000191:economics / Q000627:therapeutic use; D014009:Onychomycosis / Q000188:drug therapy* / Q000191:economics; D011728:Pyridones / Q000191:economics* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D000077291:Terbinafine; D014481:United States
chemical_list: D000935:Antifungal Agents; D009281:Naphthalenes; D011728:Pyridones; D000077768:Ciclopirox; D017964:Itraconazole; D006118:Griseofulvin; D015725:Fluconazole; D000077291:Terbinafine