法国对创新医疗技术的评估:早期获取和融资
Capucine Serain1, Sylvie Chevret2, Yann Chambon3
1Medicines Assessment Department (SEM), Evaluation and Access to Innovation Department (DEAI), HAS, Saint-Denis La Plaine, France.
概括
法国提供了例外途径,以加快患者获得创新医疗技术的速度. 虽然药品有效地利用快速通道选项,但医疗器械和程序使用量不足,数据质量是批准的主要障碍.
科学领域:
- 医疗保健创新 医疗保健创新
- 监管事务 监管事务
- 卫生技术评估 卫生技术评估
背景情况:
- 创新的医疗保健技术对于未得到满足的医疗需求至关重要.
- 豁免计划旨在加速患者获得有益的创新.
- 法国已经制定了管理创新准入和相关风险的具体途径.
研究的目的:
- 描述法国加速获得医疗保健创新的途径.
- 分析这些途径在管理不确定性和患者风险方面的效率.
- 提供有关法国监管方法的反,其中涉及HAS (Haute Autorité de Santé).
主要方法:
- 在法国,审查涉及HAS的早期和临时访问途径.
- 对2015年至2024年6月的HAS决策进行分析.
- 讨论创新医疗技术评估过程中的挑战.
主要成果:
- 法国路径区分药品,医疗器械 (MD) 和程序.
- 早期资金可用于MD和程序;药品和 (数字) MD的快速获取.
- 从2015年到2021年,批准率为:药品的70%左右,MD/手术的30%左右.
结论:
- 快速流程对于药品来说已经很成熟,但对于MD和程序来说却不那么成熟.
- 数据的质量和成熟度是所有创新类型的批准的主要限制.
- 与患者安全和伦理考虑平衡快速创新准入仍然是一个关键的挑战.
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