ECONOMIC-EVALUATION OF ANTIFUNGAL AGENTS IN THE TREATMENT OF TOENAIL ONYCHOMYCOSIS IN GERMANY

Background: The strategies for the management of onychomycosis have ch anged since the availability of the newer generation of antifungal age nts, particularly, itraconazole and terbinafine. Itraconazole (I-week pulse) therapy may have higher efficacy and an improved adverse-effect s profile compared to the continuous therapy regimen. Objective: We pe rformed a pharmacoeconomic evaluation of the most commonly used treatm ents in Germany for toenail onychomycosis from a health care payer per spective. Methods: A 5-step approach was used. Firstly, the purpose of the study, the comparator drugs, their dosage regimens and the time f rame of the analysis were defined. Next, the medical practice and reso urce consumption patterns associated with the treatment of onychomycos is 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 p erformed, Finally, a sensitivity analysis was carried out. Results: Fo r the four main comparator drugs used to treat toenail onychomycosis i n Germany, the clinical response rates (clinical cure plus marked impr ovement) at the end of the follow-up period (month 12 after starting t herapy) were, for itraconazole (1-week pulse dosing): 89.8 +/- 3% (mea n +/- 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 ind icated that itraconazole (1-week pulse dosing) and terbinafine had sim ilar cost-effectiveness ratios. Conclusion: Itraconazole is an effecti ve, broad-spectrum triazole used as continuous or pulse therapy in the treatment of onychomycosis. Itraconazole (1-week pulse) and terbinafi ne are the most cost-effective therapies for toenail onychomycosis.