Inebilizumab for neuromyelitis optica spectrum disorders in Italy: a budget impact model

BackgroundThe Italian National Health Service (INHS) has recently reimbursed the monoclonal antibody inebilizumab as a second line monotherapy after rituximab (RTX) use for neuromyelitis optica spectrum disorders (NMOSD) patients >= 18 years anti-aquaporin 4 antibody-immunoglobulin G positive, who experienced a relapse in the last year or cannot receive RTX, if incident patients. Other INHS-reimbursed drugs for NMOSD treatment are satralizumab, eculizumab and, off-label, besides RTX, ocrelizumab, tocilizumab, and immunosuppressants.Research design and methodsA 3-year (2023-2025) prevalence-based budget impact model following the INHS viewpoint compared the costs and the NMOSD attacks without (1st scenario) and with inebilizumab (2nd scenario). The epidemiology of NMOSD, and the INHS-funded healthcare resources (drugs and their administration; specialist visits; hospitalizations due to drug-related adverse events and NMOSD attacks) were obtained from the literature. One-way, threshold value and scenario sensitivity analyses investigated the robustness of the baseline findings.ResultsDuring 2023-2025 inebilizumab saves the INHS euro8,373,125.13 (1st scenario: euro176,770,028.63; 2nd scenario: euro168,396,903.50) and 12.74 NMOSD attacks (1st scenario: 213.94; 2nd scenario: 201.19). Sensitivity analyses confirmed the robustness of the baseline results.ConclusionInebilizumab reduces the INHS expenditure for NMOSD drugs. Future research should explore the cost-effectiveness of inebilizumab vs other NMOSD-targeting drugs in Italy.

Automated summary

In Italy, the Italian National Health Service (INHS) has started reimbursing the treatment costs for NMOSD patients with inebilizumab as a second line monotherapy after rituximab use. It is eligible for patients aged 18 or above, who are anti-aquaporin 4 antibody-immunoglobulin G positive and experienced a relapse in the last year or cannot receive rituximab. Other reimbursed drugs for NMOSD treatment in Italy include satralizumab, eculizumab, and off-label use of ocrelizumab, tocilizumab, and immunosuppressants.