计划发射后证据生成:法国,英国和西班牙的教训
Seamus Kent1, Francois Meyer2, Alina Pavel2
1Erasmus University Rotterdam, Rotterdam, the Netherlands.
Clinical pharmacology and therapeutics
|February 17, 2025
概括
预测早期的证据需求和简化数据收集对于有效的推出后证据生成 (PLEG) 至关重要. 加强国际合作可以提高新药补偿决定的速度和质量.
科学领域:
- 卫生经济学 卫生经济学
- 制药政策 制药政策
- 现实世界的证据.
背景情况:
- 由于技术进步和监管变化,药品在推出时面临越来越多的临床和经济不确定性.
- 推出后持续的证据生成对于评估新药的实际价值至关重要.
- 现有的推出后证据生成 (PLEG) 系统需要检查以确定需要改进的领域.
研究的目的:
- 为了比较法国,西班牙和英国在PLEG规划和运营方面的国家方法.
- 在不同医疗保健系统中确定PLEG的共同挑战和最佳实践.
- 为优化PLEG流程和决策提供建议.
主要方法:
- 分析法国,西班牙和英国的发射后证据生成 (PLEG) 系统.
- 由RWE4Decisions主办的多方利益相关者圆桌会议收集的见解.
- 介绍和讨论,涉及HTA机构,付款人和行业的代表.
主要成果:
- 尽管在PLEG应用和运营方面存在国家差异,但在系统和利益相关者之间存在共同的挑战.
- 承认需要更早地预测证据要求,以避免或更好地规划PLEG.
- 通过更多地利用现有数据,优先考虑关键成果和加强国际合作来简化数据收集的需求.
结论:
- 改善科学咨询流程和促进国际合作对于早期讨论数据缺口至关重要.
- 高效有效的证据收集可以加快和提高退款和定价决策的质量.
- 优化PLEG对于管理与新药相关的临床和经济不确定性至关重要.
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