数字健康解决方案的动态HTA:以患者为中心的评估的机遇和挑战
Jan B Brönneke1, Annika Herr2, Simon Reif3,4
1Health Innovation Hub of the German Federal Ministry of Health, Berlin, Germany.
德国的数字医疗保健法允许使用可处方的数字医疗应用程序 (DiGA). 使用现实世界的证据 (RWE) 进行持续评估对于动态的医疗技术评估和提高DiGA质量至关重要.
科学领域:
- 数字健康数字健康
- 卫生技术评估 卫生技术评估
- 监管科学 监管科学
背景情况:
- 德国2019年"数字医疗保健法" (DVG) 为数字医疗应用程序 (DiGA) 建立了一个新的退款途径.
- 这一途径允许处方可用的,以患者为中心的数字工具,由法定医疗保险补偿.
- 目前有49个DiGA可用,覆盖7300万受益人.
研究的目的:
- 探索适应医疗技术评估 (HTA) 方法的数字健康应用 (DiGA).
- 突出在德国监管框架内评估DiGA的挑战和机会.
- 在正在进行的DiGA评估中,倡导使用现实世界的证据 (RWE).
主要方法:
- 描述DiGA的HTA区分的关键问题,包括灵活的研究设计和动态的产品评估.
- 介绍德国的DiGA计划作为一个案例研究.
- 强调RWE在持续的DiGA评估中的作用.
主要成果:
- 全面的随机对照试验 (RCT) 对于经常更新的 DiGA 往往是不可行的.
- 现实世界数据 (RWD) 和RWE对于动态医疗技术评估 (HTA) 是必不可少的.
- 灵活的研究设计和为初始证据生成提供一年的宽限期是DiGA计划的特点.
结论:
- 使用RWD进行持续评估是一种监管创新.
- 这种方法可以显著提高数字健康应用的市场质量.
- 适应HTA方法对于未来的数字健康报销至关重要.
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