Department of Health Promotion and Education, Maastricht University, School for Public Health and Primary Care (CAPHRI), Maastricht, The Netherlands.
Department of Clinical Immunology & Rheumatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Department of Rheumatology, Hospital Garcia de Orta, Almada, Portugal.
Ann Rheum Dis. 2014 Nov;73(11):2010-21. doi: 10.1136/annrheumdis-2013-203819. Epub 2013 Aug 12.
To explore criteria regulating treatment with reimbursed biologic disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) across Europe and to relate criteria to indicators of national socioeconomic welfare.
A cross-sectional study among 46 European countries. One expert from each country completed a questionnaire on criteria regulating the start, maintenance/stop and switch of reimbursed bDMARDs. A composite score was developed to evaluate the level of restrictions in prescription of a first bDMARD (0=highly restricted, 5=most liberal). The level of restrictiveness was correlated with national socioeconomic welfare indicators.
In 10 countries (22%), no bDMARD was reimbursed. Among 36 countries with at least one biologic reimbursed, 23(64%) had no requirement for disease duration to initiate a biologic. Half of the countries required a failure of two synthetic DMARDs to qualify for therapy. 31 countries specified a minimum level of disease activity to be fulfilled and in 20 (56%) countries cut-off for disease activity score with 28-joint assessment was higher than 3.2. Four countries (11%) had the maximum composite score (most liberal) and 20 (56%) scored between 0 and 2 (more restrictive). Criteria for initiation of a bDMARD were negatively associated with countries' socioeconomic welfare (-0.34 to -0.64), and a moderate positive correlation was found between the composite score and welfare indicators (0.59-0.72). Only some countries had regulations for stopping (n=14(39%)) or switching (n=19(53%)).
Clinical criteria regulating prescription of bDMARDs in RA differ significantly across Europe. Countries with lower socioeconomic welfare tend to have stricter eligibility criteria, pointing to inequities in access to treatment.
探讨欧洲各国类风湿关节炎（RA）患者接受报销生物制剂的治疗标准，并将这些标准与国家社会经济福利指标联系起来。
这是一项在 46 个欧洲国家进行的横断面研究。每个国家的一名专家完成了一份关于调节报销生物制剂起始、维持/停药和转换的标准的问卷。制定了一个综合评分来评估起始使用一种生物制剂的限制程度（0=高度受限，5=最宽松）。限制程度与国家社会经济福利指标相关联。
在 10 个国家（22%）中，没有生物制剂被报销。在至少有一种生物制剂报销的 36 个国家中，23 个国家（64%）没有要求疾病持续时间才能开始使用生物制剂。一半的国家要求在开始生物治疗前要先失败两种合成 DMARD。31 个国家规定了必须达到的最低疾病活动水平，在 20 个国家（56%）中，28 个关节评估的疾病活动评分截止值高于 3.2。有 4 个国家（11%）的综合评分最高（最宽松），20 个国家（56%）的评分在 0 到 2 之间（更严格）。起始生物制剂的标准与国家社会经济福利呈负相关（-0.34 至-0.64），综合评分与福利指标之间存在中度正相关（0.59-0.72）。只有一些国家有关于停止（n=14（39%））或转换（n=19（53%））的规定。
欧洲各国调节 RA 患者使用生物制剂的临床标准存在显著差异。社会经济福利较低的国家往往有更严格的资格标准，这表明在治疗机会方面存在不平等。
