AMCP真实世界的证据标准:克服在美国付款人决策中使用真实世界的证据的障碍
Catherine M Lockhart1, Elizabeth Powers2, Brian Sweet3
1AMCP Research Institute, Alexandria, VA.
Journal of managed care & specialty pharmacy
|September 18, 2025
概括
美国付款人希望使用现实世界的证据 (RWE),但缺乏具体的标准. 管理护理药房学院 (AMCP) 制定了RWE标准,以指导付款人关于药品保险和退款的决定.
科学领域:
- 卫生经济学和结果研究研究.
- 制药政策 制药政策
- 现实世界的证据生成.
背景情况:
- 美国付款人希望将现实世界的证据 (RWE) 纳入药品保险和退款决策中.
- 使用RWE的一个重大障碍是缺乏针对付款人的需求量身定制的标准化评估和解释方法.
研究的目的:
- 建立支持美国付款人决策的RWE标准.
- 制定研究类型和终点的框架,在产品的整个生命周期中具有相关性.
- 创建专门针对美国纳税人评估和应用RWE的标准.
主要方法:
- 通过管理护理药学学院 (AMCP) 研究院和IQVIA召开了一个多利益相关者RWE专家小组.
- 通过文献搜索进行调查和研讨会,以开发和完善RWE评估标准和产品生命周期框架.
- 利用共识建设,焦点小组和AMCP合作伙伴论坛来最终确定标准.
主要成果:
- 只有18%的受访付款人定期使用RWE,但80%的人表示有兴趣.
- 达成共识的是,有必要针对付款人制定特定的RWE标准.
- 完成的AMCP RWE标准包括一个框架和6个类别的29个标准清单.
结论:
- 开发的AMCP RWE标准为付款人提供了一个实用的工具.
- 这些标准促进了付款人特定的RWE评估,并指导了有影响力的RWE研究的设计和传播.
- 这些标准旨在加强RWE在表单和覆盖决策中的使用.
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