OBJECTIVES To determine the budget impact of incorporating midostaurin to induction and consolidation therapies in combination with chemotherapy agents and as monotherapy during the maintenance phase in FLT3 mutation-positive acute myeloid leukemia (AML) compared with chemotherapy with no midostaurin from the social security perspective in Argentina.

METHODS A budget impact model provided by Novartis and developed by Purple Squirrel Economics was adapted for a hypothetical healthcare payer with a population of 1,000,000 subjects covered at five years. The model included four main components: 1) Population eligible to receive midostaurin, 2) Market share of the different chemotherapy agents (scenarios with or without midostaurin), 3) Purchase costs of the drugs and the standard of care costs involved in each treatment stage (induction, consolidation, maintenance and relapse) and 4) Costs related to managing adverse events. The clinical and epidemiological parameters of the model were obtained through comprehensive bibliographic searches and a modified Delphi technique, which included local hematologists. The costs were expressed in United States dollars (USD), 2018.

RESULTS Incorporating midostaurin to the standard FLT3+ AML therapy generated savings for the healthcare payer in terms of medical costs and adverse event management, which partially compensated the higher cost of the drug. This represented a cumulative increase of USD 244,302 every 1,000,000 people in the budget of an Argentine social security healthcare payer; this accounts for an increase of 3.6% in the disease management budget when compared with the standard of care.

CONCLUSIONS Incorporating midostaurin in combination with standard chemotherapy for the induction and consolidation phases and monotherapy as maintenance therapy for patients with FLT3+ acute myeloid leukemia (AML) is associated with an increase of 0.20 USD per member per month (PMPM) in the budget of a social security healthcare payer in Argentina.