OBJECTIVES: Surgical bleeding remains a costly complication during surgery. The aim of this study is to estimate the budget impact (BI) on the Spanish National Health System (SNHS) after introducing a novel sealant to stop bleeding during surgery, based on a combination of human fibrinogen and human thrombin (HF/HT), Veraseal^®.

METHODS: A BI analysis was developed over a 3-year time horizon from the perspective of the SNHS. The targeted procedures were cardiovascular, colorectal, hepatic, and general surgeries. The therapeutic alternatives evaluated were HF/HT and the incumbent comparator.

RESULTS: The model estimated the total number of the above targeted surgeries in 2021, 2022 and 2023; 47,636; 51,252 and 54,869 surgical procedures would be potentially eligible for treatment. The results showed that the gradual introduction of HF/HT (11.02%, 13.66% and 15.95% respectively), with a list price of €287 (4mg) and €428 (10mg), could generate savings at SNHS level of €248,902 in the first year, €331,765 in the second year and €414,784 in the third year, leading to a cumulative BI of -€995,451 in three years, due to a reduced need for HF/HT use. The sensitivity analysis confirmed the robustness of the model and indicated that savings could be increased by 36% when including the optimization of vials. Reducing the list price by 43.1% produced savings of €566,412 in three years.

CONCLUSIONS: The introduction of HF/HT as a supportive treatment in adults when routine surgical techniques are insufficient to achieve hemostasia would result in important savings for the Spanish NHS: €995,451, during the first three years of its introduction.