英国早期获取药品计划:采用,批准和退款
1Cambridge, UK.
International journal of technology assessment in health care
|August 11, 2025
概括
英国的药品早期获取计划 (EAMS) 加快了药品批准,并改善了未满足医疗需求的监管成功. 然而,行政负担可能会阻碍其充分的潜力.
科学领域:
- 制药政策和监管 制药政策和监管
- 卫生技术评估 卫生技术评估
- 毒品的发展和获取.
背景情况:
- 英国药品早期获取计划 (EAMS) 于2014年成立,旨在为具有高未满足医疗需求的疾病提供许可前获取药品.
- 评估EAMS的有效性对于了解其对药物可访问性和监管途径的影响至关重要.
研究的目的:
- 评估英国早期获取药品计划 (EAMS) 的结果.
- 分析后续的营销许可 (MA),医疗技术评估 (HTA) 和进入EAMS的药物的调试决策.
- 为了比较EAMS产品与非EAMS产品的时间表和成功率.
主要方法:
- 从2014年到2025年4月,对所有已完成的EAMS计划进行了回顾性分析.
- 收集和审查了关于营销许可 (MA),医疗技术评估 (HTA) 和退款决定的数据.
- 对NICE/NHS英格兰和苏格兰药物联盟/NHS苏格兰评估的产品进行了结果分析.
主要成果:
- 在51个完成的EAMS课程中,超过一半是瘤学,从科学意见 (SO) 到MA的中位时间为4.3个月.
- 在英格兰,50%的EAMS产品获得了积极的NICE/NHS建议,而在苏格兰,73%是积极的.
- 在48%的NICE评估中,EAMS在质量上被提及,在18%的评估中,EAMS在数量上被提及.
结论:
- 与非EAMS产品相比,进入EAMS的药物表现出更快的MA和HTA时间表和更高的监管成功率.
- 只有不到一半的有前途的创新医药名称会得到完整的科学意见 (SO).
- 解决行政负担,数据要求和责任问题可以改善EAMS的采用和影响.
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