OBJECTIVES: Iron deficiency (ID) is highly prevalent in chronic heart failure (CHF) patients and imposes a significant disease burden. CHF with ID is a major reason for hospitalization and represents important costs for national health care budgets. In France, Intravenous iron therapy with ferric carboxymaltose (FCM) is the only treatment recommended for those patients. This analyze aims to evluate the budget impact of FCM versus placebo for patients with chronic heart failure and iron deficiency in the French health care setting.

METHODS: An event-based budget impact model was adapted to forecast the budget impact from the French health insurance perspective over a 5-year horizon. The main objective of the model is to assess the costs associated with changes of disease progression in patients treated with FCM versus placebo. In the model, cost saving may occur through NYHA class improvement and rate of hospitalization.

Epidemiological parameters for France are derived from a literature review. Clinical evidence is based on a pooled analysis of four clinical trials (FER-CARS-01, FAIR-HF, EFFICACY-HF and CONFIRM-HF). Cost parameters use the French Diagnostic-Related Groups and hospital activity from the French national hospitalizations database (PMSI). Market shares of FCM versus placebo are provided by Vifor Pharma. Scenario analysis assess the influence of various factors, including FCM dose, cost of other medication, cost of hospitalization, cost of outpatient visits by NHYA levels.

RESULTS: Compared to placebo, the use of FCM in France for patients with CHF and ID results in a decrease in costs associated with hospitalizations due to CHF, outpatient visits, and other medications than FCM.

CONCLUSIONS: In this study, costs of the use of FCM in iron deficient CHF from the national health insurance perspective are expected to be in favor of an increase use in France. A final round of validation with expert is carried out to ensure robustness.