Almalki Ziyad Saeed, Alshammari Mashael Mafleh, Almazrou Saja H, Alqahtani Ohud Abd Alhadi, Alkhayat Maryam Riyadh, Alnemari Shahad Fahad, Mukhemair Haya Showky, Alkredeas Sara Mohamaad, Alsuhibani Abdulrahman A, Asiri Bushra Yousif, Alalawi Tala Nouraldin, Alahmari Abdullah K, Alotaibi Fahad Obaid
Department of Clinical Pharmacy, College of Pharmacy, Prince Sattam bin Abdulaziz University, Al-Kharj, Riyadh, Saudi Arabia.
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Clinicoecon Outcomes Res. 2025 Mar 20;17:217-232. doi: 10.2147/CEOR.S503842. eCollection 2025.
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.
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.
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.
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.
奥法妥木单抗是一种全人源抗CD20单克隆抗体，是复发缓解型多发性硬化症（RRMS）一种很有前景的疾病改善疗法（DMT）。本研究从沙特医疗支付方的角度调查了其与特立氟胺相比的成本效益。这种比较对于为沙特阿拉伯的治疗策略和资源分配提供信息至关重要，在沙特阿拉伯，RRMS带来了重大的医疗负担，且获取更新的DMT正在不断发展。
构建了一个马尔可夫模型，以评估奥法妥木单抗与特立氟胺相比在沙特阿拉伯治疗RRMS的长期成本效益。该模型模拟了10年的疾病进展情况，选择这个时间范围是因其具有临床相关性且与类似研究一致。为反映沙特患者群体，该模型使用了一个假设队列，其特征与ASCLEPIOS I/II临床试验中的患者相似。该模型纳入了疾病状态之间的转移概率，主要来源于不列颠哥伦比亚省多发性硬化症（BCMS）数据库，并使用ASCLEPIOS试验的数据进行了进一步完善。为确保与沙特背景相关，利用了当地数据源，包括沙特食品药品管理局（SFDA）的药品成本和已发表的当地研究中的健康状态成本。纳入了临床专家的意见以验证模型假设。主要结局指标是每获得一个质量调整生命年（QALY）的增量成本。进行了敏感性分析以评估模型结果的稳健性。
与特立氟胺相比，在10年期间，奥法妥木单抗每QALY的增量成本效益比（ICER）为46,188美元。奥法妥木单抗在减少残疾进展方面显示出更大的影响，尤其是在疾病的早期阶段。在每QALY支付意愿（WTP）阈值为99,120美元时，奥法妥木单抗在概率敏感性分析中显示出成本效益的概率为99.14%。
这项成本效益分析表明，奥法妥木单抗在沙特阿拉伯是一种具有成本效益的RRMS治疗方法，ICER低于WTP。政策制定者应考虑将奥法妥木单抗纳入国家药品目录，并优先在RRMS早期使用，以最大限度地提高患者受益和成本效益。
