在欧洲采用生物类似胰岛素的障碍:混合方法研究
Elif Car1, Garm Habets1, Arnold G Vulto1,2
1Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Diabetes, obesity & metabolism
|September 1, 2025
概括
由于产品特点和医生习惯等因素,生物仿制胰岛素在欧洲的应用受限. 解决这些障碍是改善患者获取和负担能力的关键.
科学领域:
- 药物经济学和卫生政策
- 内分泌学
- 药物开发
背景情况:
- 生物类似胰岛素的目标是提高患者的可负担性和可获得性.
- 尽管已推出生物类似胰岛素,但其在欧洲的应用仍然不够.
- 生物类似胰岛素治疗的潜在益处受到限制.
研究的目的:
- 提供欧洲药品管理局 (EMA) 批准的胰岛素产品及其补偿情况的最新概述.
- 探索影响医生处方生物类似胰岛素与原始胰岛素的关键因素.
- 确定欧洲市场生物类似胰岛素吸收的障碍和促进因素.
主要方法:
- 混合方法方法结合定量和定性分析.
- 欧洲药物管理局批准的胰岛素产品和九个欧洲国家的补偿数据的定量分析.
- 定性阶段涉及20名医生进行半结构面试,以了解处方影响.
主要成果:
- 由欧洲药物管理局 (1996-2022) 批准的43种胰岛素产品,其中6种 (14. 0%) 是生物类似药.
- 欧洲药品管理局批准的胰岛素的平均补偿率为56. 3%,因国家而异.
- 医生的处方决定受产品相关因素 (例如,第二代类似物,设备兼容性),行业因素 (例如,公司声誉,营销) 和医生的习惯的影响.
结论:
- 多种相互关联的因素导致生物类似胰岛素在欧洲的应用有限.
- 产品特点,制药业的影响和医生相关因素是重要的障碍.
- 需要有针对性的政策干预措施来解决这些障碍并促进生物类似胰岛素的采用.
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