OBJECTIVE: To compare the cost-effectiveness of a Elidel (pimecrolimus cream 1%) in the long-term management of children with atopic dermatitis. METHODS: Data were taken from a double-blind, multicenter, randomized, parallel-group study. Patients were randomised (2:1) to receive pimecrolimus treatment paradigm (i.e. emollients, pimecrolimus, medium potency topical corticosteroids) or standard of care (emollients, vehicle, medium potency topical corticosteroids). The study was conducted in children and adolescents (2 to 18 years of age, 474 patients on pimecrolimus and 237 patients on standard of care). Costs were estimated by linking severity of disease as defined by Investigator's Global Assessment (IGA) to average treatment costs. Drug costs were estimated from the clinical trial data. Efficacy was measured in number of patients with 0 flares over 12 months ("successfully treated patient", STP) and average number of flares as reported in the clinical trial. RESULTS: In the children and adolescent study, 68.4% of patients on pimecrolimus and 43.5% of patients on standard of care had no flare over the total study period of 12 months, a difference of 24.9%. The average number of flares in the pimecrolimus treatment group was 0.48, compared to 3.36 in the standard of care group, a reduction of 2.88 flares. Patients on pimecrolimus cost GBP 1009, patients on standard of care GBP 448, an incremental cost of GBP 561 over 12 months. 4.0 patients needed to be treated to achieve one STP, the cost per STP was GBP 2255 and the cost per flare avoided was GBP 195. The results were sensitive to the assumption of drug substance used, which is closely linked to the cost of treatment. CONCLUSIONS: Pimecrolimus has a very reasonable cost-effectiveness as measured by the incremental cost per additional successfully treated patient and the incremental cost per flare avoided.