OBJECTIVES: Atopic dermatitis (AD) is a chronic, relapsing, inflammatory systemic condition. Recently, dupilumab has been reimbursed by Italian Medicines Agency (AIFA) for the treatment of adolescents (according to the AIFA registry criteria) and adults with severe AD. Furthermore, it has been authorized by European Medicines Agency in children with severe AD. The objective of this analysis was to estimate the incremental cost-effectiveness ratio (ICER) of dupilumab versus current supportive care (SC), for the treatment of severe AD in children (6-11 years) and adolescents (12-17 years) in Italy.

METHODS: A 1-year decision tree followed by a lifetime horizon Markov model were used to conduct the cost-effectiveness analysis. The base-case analysis was performed on the overall population of the studies LIBERTY AD ADOL 1526 and LIBERTY AD PEDS 1652, adopting the Italian National Health Service (NHS) perspective. The following costs were considered: treatment acquisition, disease, adverse events, and complication management. Model robustness was tested through sensitivity analyses.

RESULTS: In the base-case, over lifetime, dupilumab was more effective than SC, in both children and adolescent populations (+2.42 and +1.60 quality-adjusted life years -QALYs-, respectively). The introduction of dupilumab led to an increase in treatment costs (+€64,675 and +€52,578, respectively for children and adolescents), partially offset by a decrease in the costs of disease and complication management. The incremental cost-effectiveness ratios (ICER) were €21,462 per QALY gained, for the children, and €26,886 per QALY gained, for the adolescent population. In both cases, the resulting ICER was below the willingness-to-pay threshold considered in Italy (€50,000 per QALY gained). Both one-way deterministic and probabilistic sensitivity analyses confirmed the robustness of base-case results.

CONCLUSIONS: Dupilumab is a cost-effective option for the treatment of adolescent and children with uncontrolled severe AD in Italy compared with SC, from the NHS perspective, validating the results obtained in the adult population.