罗马尼亚延迟获得创新药物:对退款流程 (2015-2024) 的全面分析 (2015-2024)
Constantin Radu1, Diana Elena Serban1, Nona Delia Chiriac1
1Novartis Pharma Services, Bucharest, Romania.
Frontiers in public health
|June 16, 2025
概括
罗马尼亚 罗马尼亚 罗马尼亚 罗马尼亚
科学领域:
- 卫生经济学 卫生经济学
- 制药政策 制药政策
- 药物补偿框架 药物补偿框架
背景情况:
- 罗马尼亚的药品报销依赖于健康技术评估 (HTA),导致有条件或无条件的决定.
- 有条件决策利用成本量 (CV) 协议来管理财务风险,但延迟和积压正在增加.
- 这项研究量化了延误,并评估了罗马尼亚药品报销制度的趋势.
研究的目的:
- 系统量化罗马尼亚药品退款流程中的延误.
- 评估这些延迟随着时间的推移而发生的变化.
- 在当前政策下预测未来的积压增长.
主要方法:
- 罗马尼亚国家药物管理局对613份公开的HTA报告 (2015-2024) 的分析.
- 666个指标的分类根据HTA决定 (无条件,有条件,负面) 和退款状态.
- 对HTA和偿还时间的描述性分析,Kaplan-Meier生存分析和积压预测的线性回归.
主要成果:
- 从2020年到2024年,HTA过程的持续时间减少了一半,但从HTA决定到退款的时间显著增加.
- 与无条件决定相比,有条件的决定导致更长的偿还时间 (2024年平均长274天),而无条件的决定则比无条件决定更长.
- 未获得补偿的药物指标积累量从47个 (2022年) 增加到146个 (2024年),预计到2026年将达到247个.
结论:
- 尽管HTA流程得到了改进,但由于预算和行政问题,有条件退款的延迟仍然存在,这影响了患者的获取,特别是在瘤学中.
- 加强行政能力,多样化管理入境协议 (MEA) 和采用数字工具至关重要.
- 如果不进行改革,积压将会加重,限制获得创新疗法的机会.
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