Economic analysis of oral and topical therapies for onychomycosis of the toenails and fingernails.

OBJECTIVE Several antifungal agents are indicated for onychomycosis, a fungal infection of the toenails and fingernails. These agents differ in their dosing regimen, efficacy, adverse events profile, potential for drug interaction, and cost. We conducted a pharmacoeconomic analysis of oral and topical therapies for onychomycosis from the perspective of a hypothetical managed care payer to determine the most cost-effective agent. DESIGN A decision analytic model was developed to evaluate the pharmacoeconomic profiles of itraconazole-continuous (Sporanox, Janssen Pharmaceutica), itraconazole-pulse (Sporanox, Janssen Pharmaceutica), terbinafine (Lamisil, Novartis Pharmaceuticals), and ciclopirox (Penlac, Dermik Laboratories) in the treatment of fingernail and toenail onychomycosis. METHODOLOGY We conducted a meta-analysis of the available literature to populate the decision analytic model with clinical point estimates for success, failure, and relapse. A panel of expert dermatologists defined resources consumed during the onychomycosis treatment process. These resources were then assigned values, using publicly available data sources, to reflect the U.S. managed care perspective. These clinical and economic data elements were integrated in the decision analytic model to arrive at the expected cost of treatment for each drug. Additionally, incremental cost-effectiveness was calculated for treatment success and disease-free days achieved by each therapy. Finally, a policy-level analysis of the budgetary impact of using the therapies for onychomycosis in a managed care setting was conducted. RESULTS The meta-analysis demonstrated terbinafine to be the therapeutic alternative with the highest success rate for both fingernails (96.55 percent) and toenails (81.15 percent). Terbinafine also had the lowest relapse rate (6.42 percent) and the highest number of disease-free days for both fingernails and toenails. Subsequently, in terms of cost-effectiveness, terbinafine dominated all other comparators for fingernails and toenails. CONCLUSIONS Based on the patient-level analysis, we concluded that terbinafine is the most cost-effective therapy in the treatment of onychomycosis from a managed care perspective. Furthermore, at the policy level, increased utilization of terbinafine among onychomycosis patients is likely to reduce the managed care organizations' per member per month cost.