Abstract

The very fact that multiple sclerosis (MS) is incurable and necessitates life-long care makes it one of the most burdensome illnesses. The aim of this study was to compare the cost-effectiveness of orally administered medications (e.g., fingolimod, dimethyl fumarate, and teriflunomide), interferon (IFN)-based therapy, and monoclonal antibodies (MABs) (e.g., natalizumab and rituximab) in the management of relapsing-remitting multiple sclerosis (RRMS) in Saudi Arabia using real-world data. This was a retrospective cohort study in which patients with RRMS aged ≥18 years without any other chronic health conditions with non-missing data for at least 12 months were recruited from the electronic health records of a university-affiliated tertiary care center. Multiple logistic regressions controlling for age, sex, and duration of therapy were conducted to examine the odds of disability progression, clinical relapse, MRI lesions, and composite outcome (e.g., relapse, lesion development on MRI, disability progression). The number of patients who met the inclusion criteria and were included in the analysis was 146. Most of the patients were female (70.51%) and young (e.g., ≤35 years of age). There were 40 patients on the orally administered agents (e.g., dimethyl fumarate, teriflunomide, fingolimod), 66 patients were on IFN-based therapy (e.g., Rebif®), and 40 patients were on monoclonal antibodies (e.g., rituximab and natalizumab). Patients on MABs had lower odds of the composite outcome (OR = 0.17 (95% CI: 0.068–0.428)). The use of orally administered agents was dominant (e.g., more effective and less costly), with average annual cost savings of USD −4336.65 (95% CI: −5207.89–−3903.32) and 8.11% higher rate of effectiveness (95% CI: −14.81–18.07) when compared with Rebif®. With regard to the use of MABs in comparison to Rebif®, MABs were associated with higher cost but a better rate of effectiveness, with an average additional annual cost of USD 1381.54 (95% CI: 421.31–3621.06) and 43.11% higher rate of effectiveness (95% CI: 30.38–61.15) when compared with Rebif®. In addition, the use of MABs was associated with higher cost but a better rate of effectiveness, with an average additional annual cost of USD 5717.88 (95% CI: 4970.75–8272.66) and 35% higher rate of effectiveness (95% CI: 10.0–42.50) when compared with orally administered agents. The use of MABs in the management of RRMS among the young patient population has shown to be the most effective therapy in comparison to both IFN-based therapy (e.g., Rebif®) and orally administered agents, but with higher cost. Orally administered agents resulted in better outcomes and lower costs in comparison to IFN-based therapy. Future studies should further examine the cost-effectiveness of different disease-modifying therapies for the management of RRMS using more robust study designs.

Highlights

  • Multiple sclerosis (MS) is a complex neurodegenerative inflammatory disease that affects the central nervous system (CNS) by demyelinating the myelin sheaths resulting in severe physical and/or cognitive disability [1,2]

  • About 27% of the patients were treated with oral agents, 45.21% were treated with interferon beta-1a (e.g., Rebif®), and 27.39% were treated with monoclonal antibodies (MABs)

  • The mean age of patients who were treated with oral agents, MABs, and interferon beta-1a were 33.66 years, 29.87 years, and 30.97 years, respectively, with no statistically significant difference between the three treatment groups (p > 0.05)

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Summary

Introduction

Multiple sclerosis (MS) is a complex neurodegenerative inflammatory disease that affects the central nervous system (CNS) by demyelinating the myelin sheaths resulting in severe physical and/or cognitive disability [1,2]. It is estimated that approximately 2.8 million patients worldwide have multiple sclerosis, with a prevalence rate of 35.9 cases per 100,000 people [4,5]. The reported prevalence of MS in Saudi Arabia is estimated to be 40.4 per 100,000 people, including non-Saudis [5,6]. The prevalence is much higher among Saudis, with an estimated prevalence rate of 61.95 per 100,000 people based on a recently published study that used a national registry of MS in Saudi Arabia [6]. The mean age of MS onset was 27.8 years, which is similar to the published estimates from other Middle Eastern countries [6]

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