在可互换的生物相似名称后,处方发放胰岛素格拉
Stephen J Murphy1, Nicholas C Holtkamp1
1US Department of Health and Human Services, Washington, DC.
JAMA health forum
|May 2, 2025
概括
第一个可互换的生物类似药,胰岛素格拉 (Semglee),在获得可互换的地位后,其发行量增加了. 这表明可互换性可以改善患者获取和降低生物类似药物的成本.
科学领域:
- 卫生经济学与研究成果研究成果
- 制药政策 制药政策
- 药物经济学 药物经济学
背景情况:
- 美国食品和药物管理局 (FDA) 在2021年批准了第一个可互换的生物类似药,胰岛素格拉 (Semglee),允许药房替代.
- 在这项研究之前,这种可互换名称对处方发行模式的影响在很大程度上是未知的.
研究的目的:
- 评估Semglee向可互换名称的过渡对其处方药的效果.
- 评估可互换性在生物类似药物的使用中的作用.
主要方法:
- 一项经济评估分析了从2019年9月到2024年6月的胰岛素格拉分发数据.
- 数据来源包括IQVIA的全国处方审计和美国药房分发的PayerTrak.
- 在2021年11月互换性指定之前和之后评估了分配变化,控制了表单变化.
主要成果:
- 在可互换指定 (P=.001) 后,总体Semglee/insulin glargine-yfgn发放量 (47.41%) 显著增加.
- 零售,邮件和长期护理道的配送量增加,这表明广泛的利用率增长.
- 在推出后,胰岛素glargine-yfgn的采用在医疗保险D部分,医疗补助和现金道中超过了Semglee.
结论:
- 美国食品和药物管理局 (FDA) 首次对胰岛素格拉金 (glargine) 进行可互换的指定,与其发放量大幅增加有关.
- 可互换性似乎是推动生物类似药物利用和市场份额的关键因素.
- 这种指定有望降低医疗保健成本并改善患者获得生物类似处方药的机会.
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