OBJECTIVES: Efficient implementation of biosimilars policy at hospital level involves different internal and external stakeholders. This research aims to provide a detailed description and an efficiency assessment of the policy implemented by Centro Hospitalar e Universitário de Coimbra (CHUC) as a hospital pharmacy centralized, Fully Integrated Biosimilars utilization management System (FIBS).

METHODS: A mapping of the entire FIBS process was performed, from initial prescription to until dispensing and monitoring of biologics therapy. The step by step process and interdependencies between different stakeholders were implemented in Anylogic, a multi-paradigm simulation software. Efficiency assessment was performed by the extend of switching to or initiation of biosimilars by month, after policy implementation in October 2017 for etanercept, infliximab and rituximab.

RESULTS: FIBS relies on prescription and dispensing by international non-proprietary name. Hospital Medicines and Therapeutic Committee (HMTC) recommends the initiation of or switching to (for patients with at least 12 months on same biologic brand) the option with the best economic value. Non-biosimilar utilization has to be clinically justified on a patient by patient basis by prescribing physicians. The latter decision needs to be validated by the Hospital board, HMTC and Hospital Pharmacy which acts as system gate keeper. Total traceability including biologic identification by tradename and batch number was fully demonstrated (100% of dispensed biologics) for the 602 patients analysed: rheumatic (36.2%), gastrointestinal (28.6%) and hematologic (20.4%) diseases. Utilization of biosimilars (54.6%) surpassed branded drugs (45.4%) after just 3 months of FIBS implementation. In May 2018 biosimilars quota were: etanercept (87.7%); infliximab (88.4%); rituximab (61.9%). Overall rapid biosimilar utilization was more related to switching to (70%) than initiation of biosimilars (30%) in naïve patients to biologics.

CONCLUSIONS: The Fully Integrated Biosimilars utilization management System of CHUC demonstrate high levels of efficiency, integration and control over the utilization of biosimilars at hospital level.