欧盟卫生技术评估法规 Halo Effect:跨职能团队已经准备好了吗?
Sian Tanner1, Rebecca Coady2, Ana Lisica2
1IQVIA, 1101 CT Amsterdam, The Netherlands; anke.vanengen@iqvia.com.
Journal of market access & health policy
|February 24, 2025
概括
制造商必须为2025年的欧盟HTA法规 (HTAR) 做好准备,考虑超出市场准入范围的跨功能影响. 规划应涉及联合临床评估 (JCA) 和联合科学商 (JSC),以确保成功实施.
科学领域:
- 卫生经济学和结果研究研究.
- 监管事务 监管事务
- 进入制药市场的机会
背景情况:
- 即将于2025年发布的欧盟HTA法规 (HTAR) 需要制造商进行大量准备.
- 虽然市场准入团队是主要关注的焦点,但监管的影响扩展到各种业务职能.
- 了解这些更广泛的影响对于成功适应至关重要.
研究的目的:
- 为准备欧盟HTAR的制造商确定和概述关键的跨职能考虑因素.
- 为制造商如何将这些考虑因素纳入他们的准备计划提供指导.
- 突出联合临床评估 (JCA) 和联合科学商 (JSC) 在市场准入之外的影响.
主要方法:
- 分析已发布的欧盟HTAR指导文件.
- 对相关研究和行业出版物的务实文献综述.
- 内部分析和综合从与制药制造商的接触的见解.
主要成果:
- 欧盟HTAR需要采用战略,跨职能方法,超越传统的市场准入功能.
- 关键考虑因素包括联合临床评估 (JCA) 和联合科学商 (JSC) 对研发,监管和商业业务的影响.
- 制造商需要主动调整内部流程和资源配置,以满足法规的要求.
结论:
- 成功实施欧盟HTAR需要一个整体的,跨职能战略.
- 制造商必须预见并计划JCA和JSC的监管,临床和商业影响.
- 积极主动,综合规划对于确保患者在新的欧盟HTA框架下及时获得创新药物至关重要.
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