Langley P C, Martin R E
College of Pharmacy, University of Arizona, Tucson 85721, USA.
Am J Manag Care. 1997 Jul;3(7):1013-21.
Foundation Health Corporation, through its National Pharmacy and Therapeutics Committee, requires all pharmaceutical manufacturers and others who wish products to be considered for formulary listing to meet evidentiary and analytical standards in their submission documentation. This article details the evidentiary and analytical standards required from those making submissions and describes the methodological basis of the guidelines. This is the first time, as far as the authors are aware, that a managed care health system in the United States has required formulary submissions not only to meet clinical and economic evaluation standards, but also to take explicit account of the perspective of the managed care group in applying these techniques. Submissions are required to take what is described as a systems impact perspective. This approach is quite different, in both evidentiary and analytical terms, from standards required by health systems in other countries and standards for the economic evaluation of pharmaceuticals proposed by expert groups in the United States.
基础健康公司通过其国家药学与治疗学委员会,要求所有制药商以及其他希望其产品被纳入药品目录清单考虑范围的机构,在提交的文件中满足证据和分析标准。本文详细阐述了提交方所需满足的证据和分析标准,并描述了这些指南的方法学基础。据作者所知,这是美国首次有管理式医疗健康系统要求药品目录提交不仅要符合临床和经济评估标准,而且在应用这些技术时要明确考虑管理式医疗集团的视角。提交文件需要从所谓的系统影响视角出发。从证据和分析角度来看,这种方法与其他国家健康系统要求的标准以及美国专家小组提出的药品经济评估标准都有很大不同。