欧盟联合临床评估:利用成本效益优化使用的框架 - - 决策
Adam Johns1, André Andrade1, Sukhvinder Johal2
1HTA and Modelling Science, Oncology Business Unit, AstraZeneca, 08002 Barcelona, Spain; andre.andrade@astrazeneca.com.
Journal of market access & health policy
|October 27, 2025
概括
欧盟联合临床评估 (JCA) 协调了医疗技术评估,但不包括经济评估. 医疗技术开发人员必须将成本效益模型与JCA PICO参数保持一致,以获得最佳的药物获取.
科学领域:
- 卫生经济学 卫生经济学
- 制药政策 制药政策
- 监管科学 监管科学
背景情况:
- 欧盟 (EU) 联合临床评估 (JCA) 条例 (EU) 2021/2282旨在在各成员国标准化医疗技术评估 (HTA).
- 瘤学是受这些变化影响的关键领域,影响了国家评估和卫生技术开发者 (HTDs).
研究的目的:
- 探索欧盟JCA框架对成本效益 (CE) 分析和HTD的影响,特别是在瘤学中.
- 在调整JCA和CE建模结果时识别挑战和机遇.
主要方法:
- 分析JCA框架的要求及其对经济评估的排除.
- 在JCA和CE框架之间对证据要求的对比.
- 讨论PICO参数多样性和需要间接比较方法的需求.
主要成果:
- 联合临床评估标准化了临床有效性和安全性评估,但需要HTD单独的CE建模.
- 在PICO调查中,多种比较器增加了复杂性,可能需要间接比较方法.
- 对于有效的决策,HTD和HTA机构之间的早期沟通至关重要.
结论:
- 调整JCA和CE建模提出了挑战,但为改进决策提供了机会.
- 积极分享国家PICO参数可以增强证据生成,并最大限度地发挥JCA框架的潜力.
- 成功实施可以使患者更好地获得创新的药物.
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