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Multicenter Study
. 2023 Apr;40(4):1803-1817.
doi: 10.1007/s12325-023-02464-7. Epub 2023 Mar 3.

Cost Analysis of Aprotinin Reintroduction in French Cardiac Surgery Centres: A Real-World Data-Based Analysis

Pascal Colson  1   2 , Jean-Luc Fellahi  3   4 , Philippe Gaudard  5   6 , Sophie Provenchère  7   8 , Bertrand Rozec  9   10 ; from the ARCOTHOVA Group
Affiliations
Multicenter Study

Cost Analysis of Aprotinin Reintroduction in French Cardiac Surgery Centres: A Real-World Data-Based Analysis

Pascal Colson et al. Adv Ther. 2023 Apr.

Abstract

Introduction: The European Medicines Agency restored aprotinin (APR) use for preventing blood loss in patients undergoing isolated coronary artery bypass graft (iCABG) in 2016 but requested the collection of patient and surgery data in a registry (NAPaR). The aim of this analysis was to evaluate the impact of APR reintroduction in France on the main hospital costs (operating room, transfusion and intensive unit stay) compared to the current use of tranexamic acid (TXA), which was the only antifibrinolytic available before APR reinstatement.

Methods: A multicenter before-after post-hoc analysis to compare APR and TXA was carried out in four French university hospitals. APR use followed the ARCOTHOVA (French Association of Cardiothoracic and Vascular Anesthetists) protocol, which had framed three main indications in 2018. Data from 236 APR patients were retrieved from the NAPaR (N = 874); 223 TXA patients were retrospectively retrieved from each center database and matched to APR patients upon indication classes. Budget impact was evaluated using both direct costs associated with antifibrinolytics and transfusion products (within the first 48 h) and other costs such as surgery duration and ICU stay.

Results: The 459 collected patients were distributed as: 17% on-label; 83% off-label. Mean cost per patient until ICU discharge tended to be lower in the APR group versus the TXA group, which resulted in an estimated gross saving of €3136 per patient. These savings concerned operating room and transfusion costs but were mainly driven by reduced ICU stays. When extrapolated to the whole French NAPaR population, the total savings of the therapeutic switch was estimated at around €3 million.

Conclusion: The budget impact projected that using APR according to ARCOTHOVA protocol resulted in decreased requirement for transfusion and complications related to surgery. Both were associated with substantial cost savings from the hospital's perspective compared with exclusive use of TXA.

Keywords: Aprotinin; Budget impact; Cardiac surgery; France; ICU stay; Tranexamic acid.

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Figures

Fig. 1
Fig. 1
Scenario assessed in the budget impact model
Fig. 2
Fig. 2
Flow chart illustrating the assessed population. *Participating centres (APR patients): Bichat-Claude Bernard Hospital, Paris: 139; Laennec Hospital, Nantes: 109; Arnaud de Villeneuve Hospital, Montpellier: 87; Louis Pradel Hospital, Lyon: 64. **In the pooled data set, centres were anonymised prior to analysis. Patient distribution was as follows: centre 1: 50 (APR) and 49 (TXA); centre 2: 64 (APR) and 64 (TXA); centre 3: 35 (APR) and 35 (TXA); centre 4: 87 (APR) and 75 (TXA)
Fig. 3
Fig. 3
One-way sensitivity analysis: difference in the budget-impact between APR and TXA settings. Central value: base case budget-impact cost saving of €2.78 million. One-way sensitivity analysis: difference in budget impact according to a variability of ± 20% for variable such as ICU length of stay, indication distribution, need for transfusion and surgery duration
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References

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