Research Department, Sorlandet Hospital, Service box 416, Kristiansand, Norway.
Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Sciences, NTNU, Norwegian University of Science and Technology, Trondheim, Norway.
BMC Health Serv Res. 2023 Sep 7;23(1):968. doi: 10.1186/s12913-023-09975-7.
Biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) are highly effective in treating rheumatoid arthritis (RA), albeit high drug cost has restricted their use in many countries. As a countermeasure, Norway implemented pharmaceutical tendering as a cost-reducing strategy. The aim of this study was to assess the annual proportion of different b/tsDMARDs registered to treat RA patients under the influence of a Norwegian pharmaceutical tendering between 2010 and 2019.
The data is collected from ten Norwegian outpatient centers. The included patients are categorized as naïve, non-naïve, and current b/tsDMARD users. 13 individual b/tsDMARDs are assessed and compared with the tender rankings from each year. Overview of subcutaneous (sc) with per oral vs. intravenous (iv) and biosimilars vs. non-biosimilar are also described.
The tender-winning b/tsDMARD was the most or second most used drug in nine out of ten years for naïve users, seven for non-naïve users, and twice for current users. The average sum of the highest and second highest proportion among naïve, non-naïve, and current b/tsDMARD users were 75%, 53%, and 50% during the ten years, respectively. The tender-winning drug was iv in eight out of ten years. However, the average total proportion of sc and per oral b/tsDMARDs was about 70% for naïve b/tsDMARD users, 50% for non-naïve b/tsDMARD users, and 60% for current b/tsDMARD users. The main contributors to sc and per oral b/tsDMARD were etanercept (reference and biosimilar) and certolizumab pegol. The main contributors to iv b/tsDMARD were rituximab reference and infliximab biosimilar. Despite low-ranking offers, rituximab reference (offered as a second-line drug) often achieved a high proportion among non-naïve and current b/tsDMARD users. After the introduction of biosimilars, their average proportion was about 40%, 40%, and 20% for naïve, non-naïve, and current b/tsDMARD users, respectively.
Based on observed data, a higher tender rank was associated with a higher proportion among naïve and non-naïve b/tsDMARD users. However, in most cases, sc b/tsDMARDs achieved a higher proportion with lower tender ranks than iv b/tsDMARDs with higher tender ranks.
生物制剂和靶向合成的疾病修饰抗风湿药物（b/tsDMARDs）在治疗类风湿关节炎（RA）方面非常有效，尽管药物费用高昂，但在许多国家的使用受到限制。作为一种对策，挪威实施了药品招标作为降低成本的策略。本研究的目的是评估 2010 年至 2019 年期间，挪威药品招标对治疗 RA 患者的不同 b/tsDMARDs 注册年度比例的影响。
数据来自挪威的十个门诊中心。纳入的患者分为初治患者、非初治患者和当前 b/tsDMARD 使用者。评估了 13 种单独的 b/tsDMARD，并将其与每年的招标排名进行比较。还描述了皮下（sc）与口服 vs. 静脉（iv）和生物类似物与非生物类似物的概述。
在 10 年中，有 9 年的初治患者中，招标中标的 b/tsDMARD 是最常用或第二常用的药物，7 年的非初治患者，2 年的当前患者。初治、非初治和当前 b/tsDMARD 用户的最高和第二高比例的平均值分别为 10 年中的 75%、53%和 50%。招标中标的药物有 8 年为 iv。然而，sc 和口服 b/tsDMARDs 的总比例平均值分别为初治 b/tsDMARD 用户的 70%、非初治 b/tsDMARD 用户的 50%和当前 b/tsDMARD 用户的 60%。sc 和口服 b/tsDMARD 的主要贡献者是依那西普（参考和生物类似物）和培塞利珠单抗。iv b/tsDMARD 的主要贡献者是利妥昔单抗参考和英夫利昔单抗生物类似物。尽管排名较低，但利妥昔单抗参考（作为二线药物提供）在非初治和当前 b/tsDMARD 用户中往往占有较高比例。生物类似物推出后，其平均比例分别为初治、非初治和当前 b/tsDMARD 用户的 40%、40%和 20%。
根据观察到的数据，较高的招标排名与初治和非初治 b/tsDMARD 用户中的较高比例相关。然而，在大多数情况下，sc b/tsDMARDs 以较低的招标排名实现了较高的比例，而 iv b/tsDMARDs 则以较高的招标排名实现了较低的比例。
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