Inebilizumab Versus Rituximab in AQP4-IgG-Positive Neuromyelitis Optica Spectrum Disorder: Evidence, Cost and Coverage Policy from a Gulf and Middle East–North Africa Perspective

Objective: Inebilizumab and rituximab provide B-cell-depleting treatment for aquaporin-4 im-munoglobulin G (AQP4-IgG)-positive neuromyelitis optica spectrum disorder (NMOSD) but differ in regulatory status, comparative evidence and acquisition cost. This review examines how uncertain comparative evidence should inform treatment selection and funding from a Gulf and Middle East–North Africa perspective. Methods: This narrative policy review synthesizes ran-domized and observational evidence, health technology assessments, regional guidance and pricing policy (sources updated 15 October 2026) and appraises three coverage approaches: pref-erential inebilizumab for all eligible patients, universal rituximab-first step therapy, and individ-ualized access within a transparent formulary. Results: Five observational cohorts comparing maintenance-treatment relapse outcomes yield heterogeneous, endpoint-dependent findings; re-sidual confounding, unequal follow-up, regimen variation and small inebilizumab samples pre-clude a reliable treatment hierarchy. Published Canadian acquisition costs favor rituximab but do not establish regional cost-effectiveness, while Saudi regulatory listing and economic-evaluation guidance offer a basis for local assessment. Conclusion: The individualized approach is proposed as a proportionate response to uncertainty, preserving rituximab alongside clinically justified ac-cess to licensed therapies. Implementation requires documented clinical selection, safety surveil-lance, timely authorization and appeals, local microcosting and registry-based reassessment. Neither regulatory approval nor acquisition price alone determines individual value, and the framework requires prospective evaluation while randomized comparative evidence matures.

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Publication Details

Journal
Preprints.org
Published
2026-10-27
DOI
https://doi.org/10.20944/preprints202610.2633.v1
Primary Topic
Multiple Sclerosis Research Studies
Type
preprint
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preprint

Inebilizumab Versus Rituximab in AQP4-IgG-Positive Neuromyelitis Optica Spectrum Disorder: Evidence, Cost and Coverage Policy from a Gulf and Middle East–North Africa Perspective

Eslam Shosha
3 links
Preprints.org
Multiple Sclerosis Research Studies
preprint

Inebilizumab Versus Rituximab in AQP4-IgG-Positive Neuromyelitis Optica Spectrum Disorder: Evidence, Cost and Coverage Policy from a Gulf and Middle East–North Africa Perspective

Eslam Shosha
preprint en

Abstract

Objective: Inebilizumab and rituximab provide B-cell-depleting treatment for aquaporin-4 im-munoglobulin G (AQP4-IgG)-positive neuromyelitis optica spectrum disorder (NMOSD) but differ in regulatory status, comparative evidence and acquisition cost. This review examines how uncertain comparative evidence should inform treatment selection and funding from a Gulf and Middle East–North Africa perspective. Methods: This narrative policy review synthesizes ran-domized and observational evidence, health technology assessments, regional guidance and pricing policy (sources updated 15 October 2026) and appraises three coverage approaches: pref-erential inebilizumab for all eligible patients, universal rituximab-first step therapy, and individ-ualized access within a transparent formulary. Results: Five observational cohorts comparing maintenance-treatment relapse outcomes yield heterogeneous, endpoint-dependent findings; re-sidual confounding, unequal follow-up, regimen variation and small inebilizumab samples pre-clude a reliable treatment hierarchy. Published Canadian acquisition costs favor rituximab but do not establish regional cost-effectiveness, while Saudi regulatory listing and economic-evaluation guidance offer a basis for local assessment. Conclusion: The individualized approach is proposed as a proportionate response to uncertainty, preserving rituximab alongside clinically justified ac-cess to licensed therapies. Implementation requires documented clinical selection, safety surveil-lance, timely authorization and appeals, local microcosting and registry-based reassessment. Neither regulatory approval nor acquisition price alone determines individual value, and the framework requires prospective evaluation while randomized comparative evidence matures.

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Multiple Sclerosis Research Studies
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