Real-World Comparative Cost-Effectiveness Analysis of Different Classes of Disease-Modifying Therapies for Relapsing-Remitting Multiple Sclerosis in Saudi Arabia

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.

Real‐World Healthcare Cost Savings and Reduced Relapse Rate with Off‐Label Rituximab versus Disease‐Modifying Treatments Approved for Relapsing–Remitting Multiple Sclerosis: A Nationwide Cost‐Effectiveness Study

“…The only previous cost-effectiveness studies of rituximab in MS were two smaller observational studies from Saudi Arabia (including 146 and 93 patients, of which 12 and 26 were treated with rituximab, respectively) and 2 simulation studies from Iran and Thailand, respectively. [28][29][30][31] Although severely limited by their size or use of simulation instead of real-world data, the results were broadly in line with our findings. Additionally, a study by a US healthcare provider indirectly assessed the cost-effectiveness of rituximab as part of the evaluation of their MS treatment optimization program.…”

“…This is the first large cost‐effectiveness analysis of rituximab for MS using real‐world data. The only previous cost‐effectiveness studies of rituximab in MS were two smaller observational studies from Saudi Arabia (including 146 and 93 patients, of which 12 and 26 were treated with rituximab, respectively) and 2 simulation studies from Iran and Thailand, respectively 28–31 . Although severely limited by their size or use of simulation instead of real‐world data, the results were broadly in line with our findings.…”

Clinical and economic evaluations of natalizumab, rituximab, and ocrelizumab for the management of relapsing-remitting multiple sclerosis in Saudi Arabia

“…[ 24 – 26 ] In a recently published study that evaluated different classes of DMTs for the management of RRMS in Saudi Arabia, mAbs (e.g., natalizumab and rituximab) were found to be the most effective DMTs in reducing the risk of physical disability progression, clinical relapse, and formation of new MRI lesions at 12 months follow–up compared to interferons (e.g., Rebif®), and orally administered DMTs (e.g., fingolimod, dimethyl fumarate, and teriflunomide). [ 27 ] However, no study has thus far examined the effectiveness and costs of individual mAbs in Saudi Arabia using real-world data. Therefore, this study aimed to compare the effectiveness of rituximab versus natalizumab in reducing the risk of disability progression, formation of new MRI lesions, and clinical relapse as well as their annual direct medical costs among RRMS patients.…”

The impact of monoclonal antibody drugs on healthcare economics in the treatment of multiple sclerosis and neuromyelitis optica spectrum disorders

“…The results showed that anti-mAb drugs were more expensive, but more effective than IFN β-1a s.c. injections and orally administered DMDs; anti-mAb drugs, compared with IFN β-1a s.c. and orally administered DMDs, yielded higher efficacy rates of 43.11% and 35%, respectively, and required average additional annual costs of $US1381.54 and $US5717.88, respectively. 15 The extent of cost-effectiveness that is expected to be achieved by reducing the indirect costs (by preventing the accumulation of disability) and the additional costs (arising from the use of anti-mAb drugs from the early phase of the disease) has not been fully elucidated.…”

“…An analysis of real‐world data was also carried out in Saudi Arabia to compare the cost‐effectiveness of orally administered DMDs (e.g., fingolimod, dimethyl fumarate, teriflunomide), IFN‐based therapy and anti‐mAb drugs (e.g., NTZ, rituximab [RTX]) in the treatment of relapsing–remitting MS. The results showed that anti‐mAb drugs were more expensive, but more effective than IFN β‐1a s.c. injections and orally administered DMDs; anti‐mAb drugs, compared with IFN β‐1a s.c. and orally administered DMDs, yielded higher efficacy rates of 43.11% and 35%, respectively, and required average additional annual costs of $US1381.54 and $US5717.88, respectively 15 …”