Mahidol University Health Technology Assessment (MUHTA) Graduate Program, Mahidol University, Bangkok, Thailand.
Neuroimmunology Unit, Department of Neurology, Neurological Institute of Thailand, Bangkok, Thailand.
BMC Health Serv Res. 2023 Oct 13;23(1):1096. doi: 10.1186/s12913-023-10099-1.
Multiple sclerosis is an inflammatory demyelination process in the central nervous system (CNS) causing neurological disability and poor quality of life. Currently, Thai Food and Drug Administration (FDA)-approved disease-modifying therapy is costly, and most patients with multiple sclerosis are ineligible for treatment in Thailand as previous studies have challenged its cost-effectiveness. Off-label use of rituximab is inexpensive and highly effective in treating multiple sclerosis, but evidence of its cost-effectiveness in Thailand is yet to be collected.
This study aimed to evaluate the cost-utility and budget impact of rituximab for multiple sclerosis treatment compared with best supportive care, the standard practice in Thailand to treat the disease. A Markov model with a one-month cycle length and lifetime horizon was applied to compare the costs and outcomes of rituximab and best supportive care based on a societal perspective. Accordingly, incremental cost-effectiveness ratios were estimated. Probabilistic and one-way sensitivity analyses were conducted to investigate parameter uncertainty. In addition, the Markov model was used to assess the 5-year budget impact from the government perspective.
A rituximab biosimilar demonstrated higher effectiveness and lower associated costs, compared to best supportive care, with the highest probability of being cost-effective (96%). The probability of relapse was the most sensitive parameter according to the one-way sensitivity analysis. The calculated budget impact of treating patients with multiple sclerosis in Thailand was 26,360,000 Thai baht (THB) or 844,255 United States dollars (USD) in the first fiscal year, and approximately 20,810,000-23,080,000 THB (666,608-739,388 USD) in the next four fiscal years.
In Thailand, a rituximab biosimilar would reduce the overall costs of multiple sclerosis treatment and should, therefore, be included in the National List of Essential Medicines.
多发性硬化症是一种中枢神经系统（CNS）的炎症性脱髓鞘疾病，导致神经功能障碍和生活质量下降。目前，获得泰国食品和药物管理局（FDA）批准的疾病修正疗法费用昂贵，而且由于先前的研究对其成本效益提出了质疑，大多数多发性硬化症患者都不符合在泰国接受治疗的条件。利妥昔单抗的超说明书使用在治疗多发性硬化症方面既便宜又非常有效，但在泰国，其成本效益的证据尚未收集。
本研究旨在评估与最佳支持性护理相比，利妥昔单抗治疗多发性硬化症的成本-效用和预算影响，后者是泰国治疗该疾病的标准做法。采用一个月为一个周期、终生为一个时间范围的马尔可夫模型，从社会角度比较利妥昔单抗和最佳支持性护理的成本和结果。相应地，估计了增量成本效益比。进行概率和单因素敏感性分析以调查参数不确定性。此外，还从政府角度使用马尔可夫模型评估了 5 年的预算影响。
与最佳支持性护理相比，利妥昔单抗的生物类似物显示出更高的疗效和更低的相关成本，具有最高的成本效益可能性（96%）。根据单因素敏感性分析，复发概率是最敏感的参数。在泰国，治疗多发性硬化症患者的预计预算影响为 2636 万泰铢（THB）或 844255 美元（USD），在第一个财政年度，接下来的四个财政年度预计将达到 2081 万至 2308 万泰铢（666608 至 739388 美元）。
在泰国，利妥昔单抗的生物类似物将降低多发性硬化症治疗的总体成本，因此应被纳入国家基本药物清单。
