Cost-Effectiveness Analysis of Ofatumumab versus Teriflunomide for Relapsing-Remitting Multiple Sclerosis: A 10-Year Markov Model.

Background and Objectives: Ofatumumab, a fully human anti-CD20 monoclonal antibody, is a promising disease-modifying therapy (DMT) for relapsing-remitting multiple sclerosis (RRMS). This study investigates its cost-effectiveness compared to teriflunomide from the perspective of Saudi healthcare payers. This comparison is crucial for informing treatment strategies and resource allocation in Saudi Arabia, where RRMS poses a significant healthcare burden and access to newer DMTs is evolving. Patients and Methods: A Markov model was constructed to evaluate the long-term cost-effectiveness of ofatumumab compared to teriflunomide for treating RRMS in Saudi Arabia. This model simulates disease progression over 10 years, a timeframe chosen for its clinical relevance and consistency with similar studies. To reflect the Saudi patient population, the model uses a hypothetical cohort with characteristics mirroring those in the ASCLEPIOS I/II clinical trials. The model incorporates transition probabilities between disease states, primarily derived from the British Columbia MS (BCMS) database and further refined using data from the ASCLEPIOS trials. To ensure relevance to the Saudi context, local data sources were utilized, including drug costs from the Saudi Food and Drug Authority (SFDA) and health state costs from published local studies. Clinical expert input was incorporated to validate model assumptions.The primary outcome measure was the incremental cost per quality-adjusted life-year (QALY) gained. Sensitivity analyses were conducted to assess the robustness of the model findings. Results: Compared to teriflunomide, ofatumumab yielded incremental cost-effectiveness ratios (ICERs) of $46,188 per QALY over the 10-year period. Ofatumumab demonstrated a greater impact on reducing disability progression, particularly in the early stages of the disease. At a willingness-to-pay (WTP) threshold of $99,120 per QALY, ofatumumab demonstrated a 99.14% probability of cost-effectiveness in probabilistic sensitivity analyses. Conclusion: This cost-effectiveness analysis demonstrates that ofatumumab is a cost-effective treatment for RRMS in Saudi Arabia, with an ICER below the WTP. Policymakers should consider including ofatumumab in national formularies and prioritize its use in early-stage RRMS to maximize patient benefit and cost-effectiveness.