品牌与通用:解决不坚持,世俗趋势和不重叠的问题
Lamar Hunt1, Irene B Murimi2, Jodi B Segal3
1Johns Hopkins University Bloomberg School of Public Health, Baltimore, USA.
概括
监管机构可以使用保险索赔数据来评估药物治疗等价性. 这项研究发现,品牌和仿制立即释放的芬拉法辛 (IR芬拉法辛) 在治疗上是相当的.
科学领域:
- 药物经济学 药物经济学
- 药学流行病学 药学流行病学
- 生物统计学 生物统计学
背景情况:
- 通用药物为品牌药物提供了具有成本效益的替代品.
- 对监管机构来说,评估市场后的治疗等价性至关重要.
- 立即释放的venlafaxine (IRvenlafaxine) 作为开发这种方法的案例研究.
研究的目的:
- 在现实环境中开发和应用一种新的方法来评估仿制药与品牌药物的治疗等价性.
- 为了评估与其品牌对应物相比,仿制IR文拉法辛的治疗等价性.
- 解决方法方面的挑战,包括患者不坚持,时间趋势和有限的治疗重叠.
主要方法:
- 使用了来自OptumLabs®的大量保险索赔数据集.
- 扩展回归不连续性方法用于生存曲线,以估计时间到事件结果的因果关系.
- 采用G计算来处理混和时间变化的因素.
主要成果:
- 开发的方法论成功地解决了诸如非遵守和世俗趋势等挑战.
- 没有发现统计学上有意义的证据表明仿制药和品牌IRvenlafaxine之间缺乏治疗等价性.
- 该研究表明,使用大型索赔数据进行市场后治疗等价性评估的可行性.
结论:
- 这些发现支持仿制药和品牌IRvenlafaxine的治疗等价性.
- 拟议的方法提供了一个强大的框架,用于对药物等价性的监管评估.
- 现实世界的数据分析是市场后药物评估和药物监督的宝贵工具.
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