Objectives Infantile hemangioma (IH) is the most common childhood benign tumour. A recent phase II/III study has demonstrated the success of propranolol for in-volution of infantile hemangioma as well as a better efficacy and safety when indirectly compared with corticosteroids. The purpose of this study was to estimate the cost-utility of propranolol (Hemangiol), a new medicinal product and the first to be authorized for this specific paediatric indication, versus corticosteroids in the treatment of proliferating infan-tile hemangioma requiring systemic therapy. Methods A life-time mixed decision tree and Markov model was developed to describe the pathway of infants with infan-tile hemangioma and to assess costs and outcomes in terms of Quality Adjusted Life Years (QALYs) from the perspec-tive of the Italian National Health Service. Clinical inputs were derived from the MA holder’s pivotal trial and lit-erature review, and were validated by disease key opinion leaders in Italy. The economic evaluation considered direct medical costs associated with infantile hemangioma, derived from public sources. Atopic dermatitis utilities were used as a proxy for infantile hemangioma Probabilistic sensitivity analysis was performed to investigate model parameter vari-abilities. Results The cumulative costs were €2,399.32 and €1,859. 68, while cumulative QALYs were 19.11 and 18.95, respec-tively for propranolol and orticosteroids (Prednisolone-Deltacortene), corresponding to an incremental cost-utility ratio of €3,372.75 per QALY. Probabilistic sensitivity anal-ysis showed that 94.60% of the 1,000 iterations fall within an a priori €30,000/QALY cost-effectiveness threshold. Conclusions Propranolol oral solution for the treatment of proliferating infantile hemangioma requiring systemic ther-apy can be considered cost-effective compared to corticos-teroids from the Italian National Health Service (NHS) per-spective at a threshold fixed at €30,000/QALY.

• Cost-utility analysis of propranolol versus corticosteroids in the treatment of proliferating infantile hemangioma in Italy