Objectives: Subcutaneous (SC) formulations of monoclonal antibodies (mAbs) allow faster and less invasive administration than intravenous (IV) routes, with comparable efficacy and safety. Beyond clinical equivalence, SC administration may reduce hospital resource use, improve patient experience, and increase treatment capacity, contributing to the sustainability of oncology care. This study aimed to develop and apply a hospital-based, multidisciplinary model to assess the economic and organizational impact of IV-to-SC transitions in oncology. Methods: A scenario-based economic and organizational analysis was conducted using real-world institutional data from a high-volume oncology center, collected before price renegotiations, to estimate the budget impact and resource implications of transitioning from intravenous to subcutaneous mAbs. The analysis included drug acquisition, pharmacy preparation, nursing administration, chair occupancy, and staff time, with preparation costs estimated using Time-Driven Activity-Based Costing (TDABC). The model was applied to two mAbs (X and Y); eligible patients were identified through institutional registries, and scenario analyses simulated partial and complete IV-to-SC substitution across clinical settings. Results: For antibody X, a full transition to SC administration increased annual treatment capacity by ~36 percent, with an additional drug expenditure of €123,354 and an overall budget impact of €66,778. For antibody Y, full SC adoption increased treatment capacity by ~19 percent, with an additional drug expenditure of €42,473 and a total budget impact of €6,671. Conclusions: SC-related efficiency gains are highly context-dependent and are maximized in settings with latent capacity demand. The proposed hospital-based HTA framework supports evidence-based adoption strategies and informs sustainable pricing and organizational decision making in oncology.
A hospital-based HTA model to assess the economic and organizational impact of intravenous-to-subcutaneous monoclonal antibody transitions in oncology
Guarneri, Valentina;Dieci, Maria Vittoria;Pasello, Giulia;
2026
Abstract
Objectives: Subcutaneous (SC) formulations of monoclonal antibodies (mAbs) allow faster and less invasive administration than intravenous (IV) routes, with comparable efficacy and safety. Beyond clinical equivalence, SC administration may reduce hospital resource use, improve patient experience, and increase treatment capacity, contributing to the sustainability of oncology care. This study aimed to develop and apply a hospital-based, multidisciplinary model to assess the economic and organizational impact of IV-to-SC transitions in oncology. Methods: A scenario-based economic and organizational analysis was conducted using real-world institutional data from a high-volume oncology center, collected before price renegotiations, to estimate the budget impact and resource implications of transitioning from intravenous to subcutaneous mAbs. The analysis included drug acquisition, pharmacy preparation, nursing administration, chair occupancy, and staff time, with preparation costs estimated using Time-Driven Activity-Based Costing (TDABC). The model was applied to two mAbs (X and Y); eligible patients were identified through institutional registries, and scenario analyses simulated partial and complete IV-to-SC substitution across clinical settings. Results: For antibody X, a full transition to SC administration increased annual treatment capacity by ~36 percent, with an additional drug expenditure of €123,354 and an overall budget impact of €66,778. For antibody Y, full SC adoption increased treatment capacity by ~19 percent, with an additional drug expenditure of €42,473 and a total budget impact of €6,671. Conclusions: SC-related efficiency gains are highly context-dependent and are maximized in settings with latent capacity demand. The proposed hospital-based HTA framework supports evidence-based adoption strategies and informs sustainable pricing and organizational decision making in oncology.
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