导航过渡:对免疫介导炎症疾病生物类似集成中的系统级因素的范围审查
Shania Kumar1, Nicola Dalbeth1,2, Chiara Gasteiger3,4
1Department of Medicine, University of Auckland, Auckland, New Zealand.
系统层面的因素对免疫媒介炎症疾病的生物相似过渡有重大影响. 解决监管,政策,基础设施和通信方面的问题是成功采用生物类似药的关键.
科学领域:
- 药物经济学和卫生政策
- 免疫学和炎症性疾病
- 药物开发和监管 药物开发和监管
背景情况:
- 患有免疫媒介性炎症疾病 (IMID) 的患者经常从原始生物药物转换为生物仿制药,以降低医疗保健支出.
- 虽然影响生物类似药的患者和从业人员因素已知,但系统层面的障碍需要进一步调查.
研究的目的:
- 在IMID中识别影响生物类似品牌转型的系统级因素.
- 从参与现实世界生物类似品牌变革的关键利益相关者收集见解.
主要方法:
- 使用Arksey和O'Malley框架进行了范围审查,并遵守PRISMA-ScR指南.
- 在主要数据库 (PubMed,Embase,Scopus,Web of Science,APA PsycInfo) 和会议记录中进行了搜索.
- 从包含的研究中提取和合成了数据.
主要成果:
- 包括47篇期刊文章和5篇会议摘要,主要来自美国,专注于类风湿病学.
- 障碍和促进因素被分为四个主题:监管流程,医疗保健系统政策/激励,基础设施/物流和通信/教育.
- 具体例子包括招标,可互换性政策,保险覆盖,供应链和患者组织参与.
结论:
- 医疗保健系统组件对于成功的生物相似转型至关重要.
- 通过利用法规,政策,基础设施和沟通的战略方法,可以指导医疗系统和治疗方法的品牌变化.
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