使用有效性和成本效益来做出药物覆盖决策:英国,澳大利亚和加拿大的比较
Fiona M Clement1, Anthony Harris, Jing Jing Li
1Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
JAMA
|October 8, 2009
概括
澳大利亚,加拿大和英国的国家药物覆盖决定依赖于相对有效性和成本效益的证据. 虽然这些因素指导了推,但由于机构流程和其他考虑因素,存在差异.
科学领域:
- 卫生经济学 卫生经济学
- 卫生政策 卫生政策
- 制药政策 制药政策 制药政策
背景情况:
- 国家公共保险计划经常根据相对有效性和成本效益的证据做出药物保险决定.
- 澳大利亚,加拿大和英国这三个领先的国际司法管辖区在覆盖决定中率先使用了这种证据.
研究的目的:
- 描述临床和成本效益证据如何为澳大利亚,加拿大和英国内的药物覆盖决定提供信息.
- 确定在基于证据的药物覆盖过程中遇到的普遍挑战.
主要方法:
- 对回顾性数据进行了描述性分析.
- 数据来源于加拿大的常用药物审查 (CDR),英国国家卫生和临床卓越研究所 (NICE) 和澳大利亚制药效益咨询委员会 (PBAC).
- 收集了截至2008年12月31日的公开信息.
主要成果:
- 国家卫生和临床卓越研究所 (NICE) 推了87.4%的提交,而共同药物审查 (CDR) 的推率为49.6%,制药效益咨询委员会 (PBAC) 的推率为54.3%.
- 关键的挑战包括临床有效性的不确定性,这往往源于研究设计不足,不适当的比较器或未经验证的代用终点.
- 观察到各国推的差异,可能是由于审查药物的差异,代理程序 (包括价格谈判) 和对类似药物的方法 ("我也"药物).
结论:
- 美国国家健康与临床卓越研究所 (NICE),制药效益咨询委员会 (PBAC) 和共同药物审查 (CDR) 在临床上有意义的影响证据的质量和强度方面面临着共同的挑战.
- 与其他相关因素一起,国家机构利用比较有效性和成本效益来支持药物覆盖决策.
- 这些评估过程的结果是由上下文因素,代理程序,谈判能力和可能不同的社会价值观所塑造的.
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