Jafari Matin, Sebty Mehrshad, Moradi Shaghayegh, Noqani Hesam, Esmaily Hadi, Mohammadnezhad Ghader
School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Faculty of Pharmacy and Pharmaceutical Science, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
Eur J Clin Pharmacol. 2025 Feb;81(2):247-267. doi: 10.1007/s00228-024-03783-6. Epub 2024 Dec 2.
Multiple sclerosis (MS) is an immune-mediated disease that has a considerable health-related quality of life interference. Various disease-modifying therapies (DMTs) in MS management have been approved by the Food and Drug Administration or are currently used off-label. DMTs aim to slow down the progression of MS and decrease the frequency of relapses. This systematic review aimed to evaluate the budget impact of DMTs worldwide.
A systematic search query was made to identify related articles in scientific databases. Eligible papers included their characteristics and model inputs, and results were extracted and reported. To critique the standard reporting of studies, a 32-item quality assessment checklist was used.
From 1865 records, 22 original budget-impact analyses (BIAs) were included. All BIAs were accepted in the quality assessment (Mean score: 84.4). The most used DMT was β-interferons and natalizumab among novel DMTs. The results of BIAs were highly sensitive to the route of administration, costs of side effects and administration, and presence of biosimilars. However, glatiramer acetate has not experienced significant discounts was the most reported budget-saving DMT.
From the results, it can be concluded the budget impact of DMTs in managing symptoms and improving the quality of life of MS patients according to the setting included in the modeling and according to specific conditions and context is different and significantly affects the results of BIAs. For accurate predictions of the effects of DMTs on the distribution of budgets in the MS population, more specific BIAs with higher quality should be done.
多发性硬化症(MS)是一种免疫介导的疾病,对与健康相关的生活质量有相当大的干扰。MS管理中的各种疾病修正疗法(DMTs)已获美国食品药品监督管理局批准,或目前正在非标签使用。DMTs旨在减缓MS的进展并降低复发频率。本系统评价旨在评估全球范围内DMTs的预算影响。
进行系统检索查询,以识别科学数据库中的相关文章。符合条件的论文包括其特征和模型输入,并提取和报告结果。为了评判研究的标准报告,使用了一份包含32个条目的质量评估清单。
从1865条记录中,纳入了22项原始预算影响分析(BIA)。所有BIA在质量评估中均被接受(平均得分:84.4)。在新型DMTs中,最常用的是β-干扰素和那他珠单抗。BIA的结果对给药途径、副作用和给药成本以及生物类似药的存在高度敏感。然而,醋酸格拉替雷未经历显著降价,是报告中预算节省最多的DMT。
从结果可以得出结论,根据建模中包含的设定以及具体条件和背景,DMTs在管理MS患者症状和改善生活质量方面的预算影响各不相同,并且对BIA的结果有显著影响。为了准确预测DMTs对MS人群预算分配的影响,应开展更具针对性、质量更高的BIA。