OBJECTIVES: To estimate the budget impact from the introduction of Ivosidenib for the treatment of patients with locally advanced or metastatic cholangiocarcinoma (CCA) with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy in Greece.

METHODS: A budget impact model was adapted from a public payer perspective over a 5-year time horizon to estimate the financial impact of Ivosidenib taking market shares from oxaliplatin-L-folinic-acid-fluorouracil (FOLFOX) and best supportive care. The number of eligible patients was estimated using data from the published literature, while the projected uptake of Ivosidenib was provided by Servier Hellas. Drug list prices as they were published in the bulletin issued on 19-March-2024 by the Greek Ministry of Health were used in the model as drug acquisition cost, while the other healthcare unit costs such as administration, monitoring, adverse events and end of life care were retrieved from published studies (€,2024). The model measured outcome was incremental budget impact from the introduction of Ivosidenib as a treatment option in patients with an IDH1 R132 mutated CCA.

RESULTS: Over the 5-year horizon, considering a constant incident number of eligible Greek patients per year, the corresponding Ivosidenib market shares were 30% in first year, 50% in third year and 70% in fifth year and the respective total expenditure increases were €355,788, €594,782 and €832,901. Using in the model analysis the published drug list prices, the cumulative budget impact over 3 and 5 years was calculated at €1,425,930 and €2,972,710 respectively.

CONCLUSIONS: The severity of CCA, in combination with the limited number of effective treatments, results in a high level of unmet need. The advent of Ivosidenib has brought a new on-label treatment option with increased clinical benefits, improving patient’s survival and their health-related quality of life, and a limited budget impact for the Greek payer.