Balancing innovation and affordability in relapsing-remitting multiple sclerosis: a budget impact analysis from Saudi...

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.

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.

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.

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.