Feasibility study of centralizing biotherapy preparations at the Annecy Genevois Hospital Center

Introduction
At the Annecy Genevois Hospital Center, biological therapies prescribed for the pharmacological management of chronic inflammatory diseases—gastrointestinal, rheumatologic, and neurologic—are currently prepared through a decentralized workflow. In the absence of specific regulatory requirements governing their in-hospital compounding, these therapies are presently prepared by nursing staff in day-care units under non-aseptic conditions. In light of the need to optimize the management and preparation pathway for biologics, the objective of this study is to assess the feasibility of centralizing the preparation of non-oncology biological therapies within the hospital pharmacy. This evaluation will be complemented by a medico-economic analysis to support decision-making and resource allocation.

Materials and methods
This retrospective study was conducted over a six-month period, from January 1 to June 30, 2024, through data collection and analysis. A decision tree was developed to identify the molecule(s) for which centralized preparation within the hospital pharmacy would be most beneficial. An analysis of the distribution of prescribed doses was carried out in order to propose standardized dosing regimens. Furthermore, a medico-economic evaluation was performed based on the collected data and extrapolated over a one-year period.

Results
According to our decision tree analysis, infliximab was identified as the most suitable biological therapy for centralized preparation. On average, 3.2 infliximab preparations are administered daily [range: 1–9], with a total of 34 different dosages prescribed, ranging from 200 mg to 1000 mg. A range of standardized infliximab doses was developed, allowing for a maximum deviation of 10% between the calculated theoretical dose (based on patient weight) and the proposed standard dose.
By centralizing the preparation of infliximab, we estimate an average annual cost saving of €4,047 (including tax) for the hospital through the substitution of Remicade^® with Remsima^®, as well as an additional saving of €9,172 (including tax) for the national health insurance system through optimized management of leftover volumes (remnants). This centralization also results in a reduction of 278.4 hours of nursing time and improves workflow efficiency for both pharmacists and pharmacy technicians.

Discussion
The centralization of biological therapy preparation within the hospital pharmacy, particularly for infliximab using standardized doses, appears to be a relevant and beneficial approach. The medico-economic evaluation highlighted both nursing time savings and economic benefits. This study serves as a starting point for implementing a centralized preparation process that could be extended to other non-oncology biologics. Such an approach ensures compliance with good preparation practices and enhances the safety of the compounding process, ultimately improving patient safety.

Key-words : pharmaceutical préparation, cost-benefit analysis, feasibility studies

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