监管和退款并行处理是否为患者提供更快的资金获取药物? 使用澳大利亚并行过程对癌症药物的评估
Yuan Gao1, Mah Laka1, Tracy Merlin1
1Adelaide Health Technology Assessment, School of Public Health, University of Adelaide, Adelaide, SA, Australia.
概括
对抗癌症药物的并行监管和报销过程大大缩短了资助建议的时间. 然而,它没有影响资助决策或提交的证据质量.
科学领域:
- 卫生经济学和结果研究研究.
- 制药政策和监管 制药政策和监管
- 卫生技术评估 卫生技术评估
背景情况:
- 同时进行监管审查和报销评估的目的是加速获得新药的机会.
- 澳大利亚的制药效益咨询委员会 (PBAC) 评估癌症药物是否可获得公共资金.
- 了解并行处理对决策和证据要求的影响对于优化药物批准途径至关重要.
研究的目的:
- 评估平行监管和退款处理对癌症药物资助决策的影响.
- 评估资金推在并行处理中的时间延迟的变化.
- 确定提交的证据类型是否在并行和顺序审查过程之间有所不同.
主要方法:
- 审查PBAC评估的癌症药物的公共监管和退款决定文件.
- 提取关于证据类型/质量,资助决策和药物指示对的时间表的数据.
- 使用单变量和多变量逻辑回归进行分析,以比较并行与顺序审查过程.
主要成果:
- 提交的并行审查报告显示,包括成本效益/成本效益分析的可能性更高 (79.7%对67.0%).
- 过程之间支持证据或与决策相关的预测指标的质量没有显著差异.
- 并行处理大大减少了药物注册和PBAC资金建议之间的时间滞后 (减少67周).
结论:
- 并行处理并没有改变向监管机构或卫生技术评估机构提交的证据类型.
- 对癌症药物的资助决策没有受到并行处理的引入的负面影响.
- 并行流程显著加快了澳大利亚癌症药物的初始资金建议的时间.
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