Economic Burden of Intravenous Decitabine Administration in Patients Affected by Acute Myeloid Leukemia Ineligible for Induction Chemotherapy and Impact of Oral Formulation Introduction: A Micro-Costing Study in Italy.

Purpose: Intravenous (IV) decitabine is a therapeutic option for patients with newly diagnosed acute myeloid leukemia (AML) ineligible for induction chemotherapy. Recently, the oral formulation of decitabine-cedazuridine demonstrated comparable efficacy and safety to IV decitabine, and pharmacokinetic equivalence. This study estimates the direct non-drug healthcare costs of IV decitabine administration in Italy, including central venous catheter (CVC) and infection management, and assesses the economic impact of oral decitabine introduction.

Methods: A micro-costing analysis from the Italian National Health Service (NHS) perspective was developed in four steps: 1) identification of the phases of IV and oral decitabine administration process, including CVC and infection management; 2) estimation of resource consumption, frequencies and proportion of patients for each phase; 3) collection of unit costs; 4) development of a cost analysis model. Inputs were retrieved from literature, public sources, IQVIA proprietary databases and a panel composed of clinicians, nurses and hospital pharmacists working in oncology departments. Two scenarios were explored: the first applying the economic impact to the population of interest over three years, the second including the cost of blood transfusions.

Results: The analysis estimated a total non-drug administration cost per patient of € 3574.6 and € 781.4 for a treatment course with IV and oral decitabine, respectively, leading to a cost impact of oral drug introduction of - € 2793.2 (-78.1%). The first scenario estimated a total saving for the Italian NHS of € 1.09 million over three years, the second scenario estimated a potential additional impact of - € 3418.6/patient due to transfusions.

Conclusion: The administration of oral versus IV decitabine is expected to generate cost savings for the Italian NHS in terms of drug administration, CVC and infection management, in patients with AML ineligible for induction chemotherapy.