发现新型抗生素的价值:传染病如何采用增量成本效益来提高新型抗生素的利用率?
Sean R Van Helden1, Lucas T Schulz2, Megan Wimmer1
1Pharmacy Practice and Translational Research Division, University of Wisconsin-Madison School of Pharmacy, United States.
Diagnostic microbiology and infectious disease
|March 24, 2024
概括
新型抗生素开发在证明成本效益方面面临挑战. 使用临床试验数据进行的调整增量成本效益比率 (aICER) 计算显示了变化的值,突出了改善结果指标 (如质量调整寿命年 (QALYs)) 的需要.
科学领域:
- 药物经济学 药物经济学
- 传染性疾病 传染性疾病
- 药物开发 药物开发
背景情况:
- 抗菌素耐药性 (AMR) 需要开发新的抗生素.
- 对新抗生素来说,市场批准后存在挑战.
- 目前的临床试验结果很难转化为标准的经济价值指标.
研究的目的:
- 总结最近批准的抗生素临床试验数据.
- 为了计算适应的增量成本效益比率 (aICER) 值.
- 探索调整aICER计算以适应抗微生物临床试验的限制.
主要方法:
- 随机对照研究 (2014-2022) 的系统审查和分析.
- 从18项研究中提取了8种已批准的抗生素的临床数据.
- 使用百分比死亡率或百分比治愈率作为结果计算aICER.
主要成果:
- aICER值在每百分比死亡率下为-17,374至4,966美元,每百分比治愈率下为-43,931至2,529美元.
- 塞夫托洛赞/塔扎巴克坦和伊米佩内姆/西拉斯/雷巴克坦在死亡率方面显示出成本效益.
- 目前的试验结果对标准aICER解释提出了挑战.
结论:
- 对新型抗生素的价值评估对于证明开发的合理性至关重要.
- 经过调整的ICER计算提供了初步的经济见解.
- 未来的试验应该纳入健康增益措施,如QALYs,以获得更好的价值转换.
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