Subcutaneous Ocrelizumab for the Treatment of Relapsing Forms of Multiple Sclerosis: A Budget Impact Model

OBJECTIVES: The aim of this study was to evaluate the budget impact of introducing the subcutaneous (SC) form of ocrelizumab for patients with relapsing forms of multiple sclerosis (RMS) with high disease activity (HA) despite previous treatment or with rapidly evolving severe (RES) disease in Italy from the hospital perspective. METHODS: A 3-year dynamic budget impact model with a Markov structure was developed de novo to simulate patient transitions across Expanded Disability Status Scale-defined health states. The current scenario (without ocrelizumab SC) was compared with an alternative scenario reflecting expected ocrelizumab SC uptake. Number of eligible patients reflected Italian population and projected market shares. Efficacy inputs were obtained from published literature, with adherence and persistence sourced from Italian real-world data. Unit costs-including drug administration, monitoring, adverse events, disease management, and relapse-were collected from Italian sources. Drug acquisition costs were considered in a scenario analysis. Parameter uncertainty was explored through deterministic sensitivity and scenario analyses. RESULTS: Over 3 years, 22,128 patients were eligible, of whom 5389 were assumed to receive ocrelizumab SC. Ocrelizumab SC introduction would generate cumulative savings of about €2.0 million, mainly from reduced administration and monitoring costs, with additional savings from relapse and disease management expenditures. When drug acquisition costs were included, total savings rose to roughly €7.1 million. Sensitivity analyses confirmed the robustness of these findings. CONCLUSIONS: Ocrelizumab SC may be a cost-saving and resource-efficient option for HA/RES RMS management in Italy. By reducing administration time while maintaining the established clinical profile of the intravenous (IV) formulation of ocrelizumab, its adoption can enhance hospital efficiency and deliver meaningful budgetary savings.