ORIGINAL RESEARCH article
Front. Public Health
Sec. Health Economics
This article is part of the Research TopicAdvancing Health Technology Assessment and Patient-Reported Outcomes: Innovations and Implications for Health Economics and Outcomes ResearchView all 9 articles
Balancing Innovation and Affordability in Relapsing-Remitting Multiple Sclerosis: A Budget Impact Analysis from Saudi Arabia
Provisionally accepted
Ahmed Al-Jedai1
Hajer Almudaiheem2
Faisal Al-Suweidan3
Mohammed Al Jumah4Ahmed al-Thobaiti5Fahad Alzureiqan2
Wejdan Abu Ras2Fahad M Al-Dosari2
Yaser Al Malik6Pratik Dhopte7
Rita Ojeil8*- 1Alfaisal University, Riyadh, Saudi Arabia
- 2Ministry of Health, Riyadh, Saudi Arabia
- 3Security Forces Hospital Program, Riyadh, Saudi Arabia
- 4King Abdullah International Medical Research Center, Riyadh, Saudi Arabia
- 5King Saud Medical City, Riyadh, Saudi Arabia
- 6King Saud bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia
- 7CareXso, Dubai, United Arab Emirates
- 8PDC-CRO, Dubai, United Arab Emirates
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Introduction: Relapsing-Remitting Multiple Sclerosis (RRMS) is the most prevalent form of multiple sclerosis, characterized by episodic neurological deterioration and recovery. The rising burden of RRMS in Saudi Arabia, underscores the need for cost-effective treatment strategies. This study evaluates the economic impact of disease-modifying therapies (DMTs) for RRMS from a national healthcare payer perspective, with a focus on the role of managed entry agreements (MEAs) in optimizing affordability. Methods: A budget impact analysis was conducted using an Excel-based model over a 5-year period. The model incorporated real-world uptake scenarios derived from expert opinion and hypothetical 100% uptake. The eligible population was stratified by treatment status and disease severity. Costs included drug acquisition, administration, monitoring, relapse management, and adverse event management. Scenarios with and without MEAs were analyzed to estimate net budget impact. Results: MEAs were associated with reduced treatment and relapse-related costs across all patient subgroups. Ofatumumab showed favorable economic profiles under MEA conditions, while cladribine (Mavenclad®) emerged as the most cost-efficient option. Siponimod (without MEA) in Active RRMS naïve (100% uptake) resulted in the highest overall expenditure, totaling SAR 732,484,106.83, highlighting the importance of strategic pricing and reimbursement models for high-cost DMTs in RRMS. Conclusion: This is the first comprehensive exploratory economic evaluation comparing first-in-class RRMS therapies in Saudi Arabia. Findings support the adoption of MEAs and performance-based reimbursement to ensure sustainable RRMS care in resource-constrained settings.
Keywords: Budget impact analysis, relapsing-remitting multiple sclerosis, Managed entry agreements, Disease-modifying therapies, Multiple Sclerosis
Received: 25 Sep 2025; Accepted: 17 Nov 2025.
Copyright: © 2025 Al-Jedai, Almudaiheem, Al-Suweidan, Al Jumah, al-Thobaiti, Alzureiqan, Abu Ras, Al-Dosari, Al Malik, Dhopte and Ojeil. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Rita Ojeil, rita.ojeil@pdc-cro.com
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