Drug design, development and therapy · 2025
Health Technology Assessment: Evaluation of Monoclonal Antibodies for the Treatment of Neuromyelitis Optica Spectrum Disorders.
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Wang Changsheng, Wu Hanbiao, Huang Yeqing, Liu Aiqun, Lai Sha
Аннотация
OBJECTIVE: To systematically evaluate the clinical value of monoclonal antibodies for neuromyelitis optica spectrum disorders (NMOSD), a multidimensional assessment of three monoclonal antibody therapies (eculizumab, inebilizumab, and satralizumab) was conducted using the updated drug evaluation framework from the Rapid Guide for Drug Evaluation and Selection in Chinese Medical Institutions (2nd Edition). This study aims to provide evidence-based guidance for optimizing monoclonal antibody selection in clinical practice.
METHODS: A quantitative scoring system was employed across five distinct domains: pharmacological properties (28 points), efficacy (27 points), safety (25 points), economics (10 points), and other attributes (10 points).
RESULTS: The comprehensive evaluation scores, with a maximum of 100 points, were as follows: eculizumab (70.43), satralizumab (69.33), and inebilizumab (68).
CONCLUSION: Eculizumab is strongly endorsed as the first-line therapeutic option due to its optimal benefit-risk profile. Satralizumab and inebilizumab may be considered as conditional alternatives, contingent upon institutional resources and individual patient factors. This tiered recommendation framework facilitates adaptive formulary management that aligns with the evolving therapeutic landscape and socioeconomic conditions, thereby providing a replicable model for healthcare systems worldwide.
METHODS: A quantitative scoring system was employed across five distinct domains: pharmacological properties (28 points), efficacy (27 points), safety (25 points), economics (10 points), and other attributes (10 points).
RESULTS: The comprehensive evaluation scores, with a maximum of 100 points, were as follows: eculizumab (70.43), satralizumab (69.33), and inebilizumab (68).
CONCLUSION: Eculizumab is strongly endorsed as the first-line therapeutic option due to its optimal benefit-risk profile. Satralizumab and inebilizumab may be considered as conditional alternatives, contingent upon institutional resources and individual patient factors. This tiered recommendation framework facilitates adaptive formulary management that aligns with the evolving therapeutic landscape and socioeconomic conditions, thereby providing a replicable model for healthcare systems worldwide.