为欧盟HTA法规做准备:从荷兰的角度看
Anne Willemsen1,2, Maureen Rutten-van Mölken3, Riam Al Dulaimi1
1Zorginstituut Nederland, 1112 Diemen, ZA, The Netherlands.
Journal of market access & health policy
|August 27, 2025
概括
欧洲卫生技术评估法规对国家过程产生影响. 荷兰国家医疗保健研究所 (ZIN) 调整了其HTA过程,重点关注药品的早期范围和联合临床评估报告.
科学领域:
- 卫生政策
- 监管科学
- 药物评估
背景情况:
- 欧洲卫生技术评估 (HTA) 条例 (HTAR) 于2025年1月开始实施,要求欧盟成员国考虑联合临床评估 (JCA) 报告.
- 这就需要对现有的HTA框架和流程进行国家调整.
研究的目的:
- 描述根据新HTAR对荷兰国家HTA流程的预期变化.
- 概述荷兰国家医疗保健机构 (Zorginstituut Nederland,ZIN) 对HTAR的准备和实施策略.
- 分享与欧盟HTAR未来扩张相关的经验.
主要方法:
- 一个项目治理结构和ZIN目前国家药品评估和评估过程的持续差距分析.
- 根据所发现的差距和挑战制定具体的行动计划.
- 对ZIN的HTA流程的影响分析,包括早期范围和JCA报告的利用.
主要成果:
- 对于ZIN的HTA过程有两个主要影响:早期的范围评估阶段和作为国家评估的起点的JCA报告.
- 识别了各类信息/知识,IT/模板,沟通/利益相关方参与,能力/资源和财务方面的差距,挑战和问题.
- 该公司已经制定了详细的实施计划,并为HTAR做好准备.
结论:
- 该公司已准备好将HTAR纳入其国家HTA流程.
- 自2025年起,ZIN准备在药品的联合评价中担任 (联合) 评估员.
- 分享ZIN的实施经验可以使其他成员国和欧盟HTAR的未来发展受益.
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