Analisi costo-utilità di dupilumab per il trattamento della dermatite atopica grave negli adulti in Italia

BACKGROUND: Atopic dermatitis (AD) is a chronic, multifactorial, inflammatory skin disease with significant impact on patients’ quality of life. OBJECTIVE: The objective of this analysis was to estimate the incremental cost-utility ratio (ICUR) of dupilumab, administered every other week, plus supportive care (SC), vs SC, in the Italian adult population with severe AD, for whom ciclosporin treatment is contraindicated, ineffective or not tolerated. METHODS: Simulation of outcomes and costs was conducted using a 1-year decision tree, followed by a lifetime horizon Markov model. Clinical data were derived from a pooled analysis of two studies. The analysis was conducted adopting the Italian National Health Service (NHS) perspective. In the model, the following costs were considered: i) Drug acquisition costs; ii) Disease management costs; iii) Costs of adverse events. Robustness of findings was tested using both one-way deterministic and probabilistic sensitivity analyses. RESULTS: In the base case, dupilumab plus SC was more effective than SC (+2.42 quality adjusted life years, QALYs). The total lifetime cost per patient treated with dupilumab was higher than SC (€ 137,267 and € 56,744, respectively). Dupilumab plus SC was cost-effective vs. SC, with an ICUR of € 33,263 per QALY gained. The ICUR fell in the informal range of ICUR acceptability proposed for Italy (range: € 25,000-€ 40,000 per QALY gained). Sensitivity analyses confirmed robustness and reliability of base case results. CONCLUSIONS: Dupilumab plus SC is a cost-effective option for the treatment of patients with severe AD in Italy, compared with SC, when NHS perspective is considered.