OBJECTIVES: To estimate the budgetary impact from the introduction of ivosidenib in combination with azacitidine (IVO+AZA) in previously untreated patients with isocitrate dehydrogenase 1 mutated (mIDH1+) acute myeloid leukemia (AML), ineligible for intensive induction chemotherapy in Greece.

METHODS: A budget impact model was developed from a public payer perspective over a 5-year time frame to estimate the financial impact of introducing IVO to the currently available treatments for the previously untreated AML patients with mIDH1+ in Greece. Currently, therapeutic schemes based on AZA, venetoclax+azacitidine (VEN+AZA) and decitabine are available. Moreover, the model framework considered epidemiological data, market share scenarios with and without IVO and costing data. The number of eligible patients was estimated based on internal published data. The cost inputs include drug acquisition and administration, disease management, adverse events (AE) management and end-of-life costs. All unit costs correspond to the year of analysis, namely 2024 (€). The model-measured outcome was incremental budget impact from the introduction of IVO in the Greek market.

RESULTS: The introduction of IVO is forecasted to lead to increased number of patients with AML under treatment, ranging from 14 to 37 over the first and fifth year, respectively. Patients receiving IVO are expected to range from 1 to 7 in the first and fifth year, respectively. Moreover using in the model the public prices available in the Greek Ministry of Health site, the progressive adoption of IVO was associated with an incremental cost of €198,381 and €1,380,295 in the first and fifth year, respectively.

CONCLUSIONS: The inclusion of IVO for AML treatment was predicted to result in an annual average budget impact of €804,074, over a five-year time frame. This increase is notable, especially considering the low annual mortalities associated with IVO, which in turn lead to an increase in the total number of patients under treatment.