OBJECTIVES: This study aims to estimate the budget impact of deferasirox (a once-daily oral iron chelator recently marketed in Italy) in patients with beta-thalassaemia major and chronic iron overload from blood transfusions, who live in the Veneto region. Our analysis compares the costs of deferasirox versus deferoxamine (which is the current standard of care for these patients) and versus deferiprone, another oral iron chelator that is licensed only for the treatment of iron-overloaded thalassaemic patients, when deferoxamine is contraindicated or inadequate. METHODS: Our analyses was conducted from the perspective of the Italian healthcare system. The following direct medical care costs were considered: drug costs (cost to the hospital at the dosage range reported in the SPC), administration costs (medical devices for deferoxamine, hospital cost), laboratory assessments (cost of laboratory exams from SPC, using hospital reimbursement tariff). All costs are expressed as Euros (year 2007 values). We considered the patients with beta thalassaemia major that live in the Veneto region. RESULTS: According to the Regional Rare Diseases Register, in Veneto 170 patients are affected by thalassaemia. 153 are eligible for deferasirox treatment. Switching all patients from deferoxamine (estimated annual costs: €734,808 – 1,327,797), to deferasirox (estimated annual costs: €3,615,382 – 5,575,618), would cause an expenditure increase of  €2,881,074 – 4,247,823/ year.  From drug utilization data, it is estimated that about 15 patients with beta-talassemia are treated with deferiprone.  In this scenario, the budget impact of switching all patients to deferasirox would be €2,858,547 – 4,283,481. CONCLUSIONS: Besides the advantage of the oral administration instead of continous subcutaneous infusion by pump, the impact of deferasirox on the regional budget is relevant. Alternative scenarios may take into account switching to the new drug only patients subgroups (e.g., patients who do not respond to deferoxamine) or patients for whom quality of life is strongly affected by the infusion pump.