在20个国家的先进疗法药品的定价和报销机制
Juan Carlos Rejon-Parrilla1, Jaime Espin2,3,4,5, Sarah Garner6
1Health Technology Assessment Area (AETSA), Andalusian Public Foundation Progress and Health (FPS), Seville, Spain.
Frontiers in pharmacology
|December 13, 2023
概括
获得先进治疗药物 (ATMP) 在欧洲各国有很大的差异. 这种不平等的获取来源于不同的监管和报销政策,影响患者获得创新治疗的可用性.
科学领域:
- 药物经济学 药物经济学
- 卫生政策 卫生政策
- 监管科学 监管科学
背景情况:
- 先进治疗药物 (ATMP) 为未满足的医疗需求提供了显著的治疗潜力.
- 有关ATMP定价和报销 (P&R) 的付款人挑战和有限的经验研究存在.
- 中央化的欧洲营销许可方便ATMP访问,但需要P&R评估.
研究的目的:
- 对ATMP的监管和P&R决策进行全面的国际审查.
- 从2022年3月起,分析所有拥有欧洲集中营销许可的ATMP的P&R景观.
主要方法:
- 一项调查于2022年7月分发给46个国家.
- 数据收集的重点是ATMPs的监管地位和P&R决策.
- 响应率为43.5% (46个国家中有20个国家).
主要成果:
- 回答的国家中,有14个国家报告至少有一项ATMP的报销.
- 六个国家报告说,没有任何ATMP的补偿.
- 观察到ATMP退款的显著变化.
结论:
- 在所有被调查国家中,对ATMP的准入不均是明显的.
- 差异是由监管差异,商业战略和付款人评估差异驱动的.
- 需要加强国际合作,以促进公平获得新药.
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