我们是否预见到了？对瑞典早期预警系统的评估。
Did we see it Coming? An Evaluation of the Swedish Early Awareness and Alert System.
机构信息
Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Department of Healthcare Development, Stockholm County Council, Stockholm, Sweden.
出版信息
Appl Health Econ Health Policy. 2019 Feb;17(1):93-101. doi: 10.1007/s40258-018-0434-2.
BACKGROUND
Early awareness and alert systems have been established in many countries but evidence on their ability to accurately prioritize new medicines (for early assessment) is limited.
OBJECTIVE
The purpose of this study was to assess whether the Swedish Early Awareness and Alert System identified and prioritized (i.e., produced early assessment reports for) new medicines that would go on to have substantial economic impact.
METHODS
We adapted a study design commonly used in the assessment of diagnostic test accuracy. The prioritization made by the Swedish Early Awareness and Alert System prior to marketing authorization comprised the index test and the national drug sales data in the second year post-authorization served as the reference standard. All initial marketing authorization applications for medicinal products processed by the European Medicines Agency between 2010 and 2015 (study population) were classified using the index test and the reference standard.
RESULTS
Two hundred and fifty-three new medicinal products processed by the European Medicines Agency comprised the study population. Of these, 71 were prioritized by the Swedish Early Awareness and Alert System and 21 were classified as having substantial economic impact. The sensitivity and positive predictive value were 76.2% and 22.5%, respectively. Subgroup analyses showed that the accuracy of prioritization, in terms of sensitivity, was 100% for antineoplastic/immunomodulating agents.
CONCLUSIONS
The Swedish Early Awareness and Alert System identified all new medicines that would go on to have substantial economic impact and prioritized most of these medicines. Our findings provide reassurance to decision makers who rely on the outputs of the Swedish Early Awareness and Alert System to keep informed about new medicines. Moreover, this study also provides valuable insights to stakeholders willing to establish or evaluate their own early awareness and alert activities and systems.
背景
许多国家都建立了早期预警系统，但关于这些系统准确识别和优先考虑新药（进行早期评估）的能力的证据有限。
目的
本研究旨在评估瑞典早期预警和警报系统是否能够识别和优先考虑（即，生成早期评估报告）具有重大经济影响的新药。
方法
我们采用了一种常用于诊断测试准确性评估的研究设计。在获得市场授权之前，瑞典早期预警和警报系统的优先排序由索引测试和授权后第二年的国家药物销售数据组成，作为参考标准。使用索引测试和参考标准对 2010 年至 2015 年期间由欧洲药品管理局处理的所有初始药物上市许可申请进行分类。
结果
由欧洲药品管理局处理的 253 种新药物构成了研究人群。其中，71 种被瑞典早期预警和警报系统优先考虑，21 种被归类为具有重大经济影响。敏感性和阳性预测值分别为 76.2%和 22.5%。亚组分析表明，在敏感性方面，优先排序的准确性为 100%，适用于抗肿瘤/免疫调节药物。
结论
瑞典早期预警和警报系统识别出所有具有重大经济影响的新药，并对其中大多数药物进行了优先排序。我们的研究结果为决策者提供了保证，他们依靠瑞典早期预警和警报系统的输出来了解新药。此外，本研究还为愿意建立或评估自己的早期预警和警报活动和系统的利益相关者提供了有价值的见解。
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