Multi-Indication Budget Impact Analysis of Subcutaneous IgPro20 Pre-filled Syringes for the Treatment of Primary Immunodeficiency Syndromes, Secondary Immunodeficiencies, and Chronic Inflammatory Demyelinating Polyneuropathy in Italy.

چکیده اصلی

INTRODUCTION: Primary immunodeficiency (PID) and secondary immunodeficiency (SID) are chronic conditions associated with impaired immune function and increased susceptibility to infections. Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune neurological disorder characterized by progressive motor and sensory deficits due to immune-mediated demyelination of peripheral nerves. Patients with these diseases often require long-term immunoglobulin (IG) therapy, which can be costly and burdensome, particularly when administered intravenously in hospital settings. IgPro20 pre‑filled syringes (PFS) offer a simplified, subcutaneous IG alternative that may reduce treatment burden and improve cost‑efficiency. The aim of this study was to estimate the budget impact of introducing IgPro20 PFS into the Italian healthcare system for patients with PID, SID, and CIDP. METHODS: A population-based budget impact model was developed in Microsoft Excel® from the perspective of the Italian National Health Service (Servizio Sanitario Nazionale). The model used a 3-year time horizon and incorporated drug acquisition, administration, and adverse event costs. Model comparators included intravenous and subcutaneous IG and IgPro20 vials. Population estimates and market shares were informed by Italian affiliates. RESULTS: The introduction of IgPro20 PFS resulted in total cost savings of €31,524,488 for 4794 patients over 3 years. Savings were distributed across PID (€8,840,041), SID (€5,413,035), and CIDP (€17,271,412). Sensitivity analyses identified IgPro20 PFS and vial pricing as key drivers. CONCLUSION: IgPro20 PFS are a cost-saving, patient-centric treatment option for PID, SID, and CIDP. These findings support their adoption in Italy's healthcare system and may inform policy and payer decisions at regional and national levels.

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