Abstract:

Objective: To compare the costs and effectiveness of 2 oral antifungal treatment regimens in patients with dermatophyte toenail onychomycosis.

Design and methods: A cost-effectiveness analysis using a model based on data from the Lamisil versus Itraconazole in Onychomycosis (L.I.ON.) study, a randomised controlled trial comparing continuous terbinafine with intermittent itraconazole. The trial included 4 treatment arms: terbinafine 250 mg/day for 12 or 16 weeks (T, T) and itraconazole 400 mg/day for 1 week in every 4 weeks for 12 or 16 weeks (I, I). Cost calculations for 6 countries (Finland, Germany, Iceland, Italy, The Netherlands, UK) included costs for medication, physician visits, laboratory tests, management of adverse events and management of relapse. Effectiveness was based on complete cure rates (mycological cure plus 100% toenail clearing). Costs per complete cure were determined and both average and incremental cost-effectiveness ratios were calculated.

Perspective: Healthcare system.

Main outcome measures and results: In the L.I.ON. study, terbinafine was seen to be more effective than itraconazole (cure rates, 45.8 vs 23.4%). In most comparisons (5 of the 6 countries), the costs of T were statistically significantly lower than those of I [range: -37 to -173 euros (EUR); 1998 values; 1.172 US dollars = EUR1], indicating that T was the dominant strategy (i.e. less expensive and more effective). One exception (Finland) showed an incremental cost-effectiveness ratio of EUR524 per additional cure. In the other 5 countries, T and I were essentially equal in cost, but the greater effectiveness of T (cure rates, 55.1 vs 25.9%) resulted in a situation of extended dominance.

Conclusion: From a healthcare system perspective, continuous terbinafine is less costly and more effective than intermittent itraconazole in the treatment of dermatophyte toenail onychomycosis.

Keywords: Antifungals, therapeutic use; Cost effectiveness; Itraconazole, therapeutic use; Onychomycosis, treatment; Pharmacoeconomics; Terbinafine, therapeutic use

Document Type: Original article

Affiliations: 1: Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands