绘制欧盟/欧洲经济区成员国和英国高风险医疗器械的当前决策途径和报销流程:一个范围审查
Rasha A Alshaikh1,2,3, Kieran A Walsh1,3, Fatma El-Komy1
1School of Pharmacy, https://ror.org/03265fv13University College Cork, Cork, Ireland.
欧洲对高风险医疗器械 (MD) 和体外诊断 (IVD) 的报销有很大差异. 本次审查审查了国家框架和证据的使用,突出了可能影响卫生技术评估条例 (HTAR) 的差异.
科学领域:
- 卫生经济学 卫生经济学
- 医疗器械规则 医疗器械规则
- 卫生技术评估 卫生技术评估
背景情况:
- 欧洲各地对高风险医疗器械 (MD) 和体外诊断 (IVD) 的报销和患者获取不同.
- 卫生技术评估条例 (HTAR) 旨在通过联合临床评估标准化临床评估.
- 报销和证据整合方面的国家差异可能会阻碍HTAR的目标.
研究的目的:
- 绘制欧盟/欧洲经济区/英国高风险的MD/IVD目前的报销框架.
- 确定国家退款流程中的关键监督结构.
- 评估在报销决策中使用比较有效性和安全性数据的使用情况.
主要方法:
- 根据PRISMA-ScR指南进行了范围审查.
- 使用一个注册的协议 (osf.io/65bdk).
- 通过与国家组织直接接触,验证了调查结果.
主要成果:
- 欧盟/欧洲经济区/英国的MD/IVD退款框架存在显著差异.
- 在34个国家中,有23个国家使用健康技术评估 (HTA) 进行MD/IVD退款;只有11个国家有正式的HTA流程.
- 八个国家有证据不确定性机制;十二个国家有集中决策,六个国家有区域/地方决策.
结论:
- 国家将HTA纳入MD/IVD退款框架的情况各不相同.
- 各国在执行国家决定和评估证据不确定性方面存在差异.
- 了解这些变异对于优化HTAR生成证据利用至关重要.
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