Abstract

Atopic dermatitis (AD) is a chronic, multifactorial, inflammatory skin disease. Dupilumab, a fully human monoclonal antibody, has been recently approved for the treatment of adolescents (aged 12-17) with uncontrolled moderate to severe AD. The objective of this analysis was to estimate the incremental cost-effectiveness ratio (ICER) of dupilumab versus current supportive care (SC) used to treat AD in Italy. Simulation of outcomes and costs was undertaken using a 1-year decision tree, followed by a lifetime horizon Markov model. The base-case analysis was conducted on the overall population of the study LIBERTY AD ADOL 1526 (full analysis set). A secondary analysis was conducted on a subgroup of patients treated with prior use of topical corticosteroids or calcineurin inhibitors. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (treatment acquisition, disease management, adverse events, management of complication – i.e. flares-) were analysed. Model robustness was tested through sensitivity analyses. In the base-case, dupilumab was more effective than SC (+1.53 quality adjusted life years, QALYs). The introduction of dupilumab led to an increase in treatment costs (+ €61,121.17), which are partially offset by a decrease in the costs of disease management and the management of complications of the disease (respectively - €8,349.80 and - €907.84). The incremental cost-effectiveness ratio (ICER) was €33,918.29 per QALY gained, below the directional willingness-to-pay threshold considered in Italy (€ 50,000 per QALY gained).The results of the alternative analysis confirmed the base-case results with a modest reduction of the ICER vs. base-case (€33,648 vs €33,918, respectively). Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. Dupilumab is a cost-effective option for the treatment of adolescent patients with uncontrolled moderate to severe AD in Italy, compared with SC, from the NHS perspective.

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