斯洛文尼亚药物早期获取计划和捐赠的特点和可用性
Lea Knez1,2, Janja Jazbar1, Mitja Kos1
1University of Ljubljana, Faculty of Pharmacy, 1000 Ljubljana, Slovenia.
The oncologist
|July 22, 2025
概括
斯洛文尼亚的早期获取计划 (EAP) 和药物捐赠计划 (MDP) 为患者及时获得新药,特别是在瘤学领域. 建议改善计划范围,及时性和透明度,以改善患者的访问.
科学领域:
- 制药政策 制药政策
- 获取毒品的计划 获取毒品的计划
- 斯洛文尼亚的医疗保健系统
背景情况:
- 早期获取计划 (EAP) 和药物捐赠计划 (MDP) 便于患者在获得监管批准或国家退款之前获得新疗法.
- 这些计划对于解决未满足的医疗需求和改善患者治疗结果至关重要.
研究的目的:
- 评估斯洛文尼亚EAP和MDP的特点和及时性.
- 确定通过这些计划获得的药物的比例和相关的时间框架.
主要方法:
- 从2010年至2019年通过中央程序通过欧洲药品署 (EMA) 批准的原始药物的分析.
- 斯洛文尼亚药品和医疗器械机构收集关于EAP和MDP的数据.
主要成果:
- 在斯洛文尼亚,有58种适应症 (12.7%) 可获得预退款,其中35种是通过EAP,26种是通过MDP.
- 瘤学适应症占主导地位 (60.3%). 在EAP中,平均21个月的预偿付 (24.7个月的瘤).
- 多项发展计划提供了9.5个月的预偿付 (9.4个月的瘤),并有可能通过更早的计划启动获得更早的访问.
结论:
- 斯洛文尼亚成功实施了EAP和MDP,重点关注瘤药物.
- 机会存在,以提高这些计划的范围,及时性和透明度,为患者.
- 在营销许可申请阶段优化计划启动可以显著改善早期准入时间表.
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