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Abstract：
OBJECTIVE: To propose a set of guidelines for use by health care organizations in the United States that seek useful, comparative clinical information and economic analysis on pharmaceutical products to make sound drug purchasing decisions.
METHODS: Based on a therapy intervention approach, the guidelines provide a structured framework to help managed care purchasers become more consistent in how they evaluate drug products for inclusion in the formulary. The guidelines factor in the need to examine the impact of new drug products on overall costs within the entire health system.
METHODS: Intended for use by managed care organizations in the U.S. that purchase prescription drugs.
METHODS: Not applicable.
METHODS: Not applicable.
RESULTS: The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population being treated and the fact that patients generally are redistributed among different treatment categories once a new drug product is introduced, thus offering MCOs an analysis model that extends beyond the traditional partial cost-outcomes approach. Emphasis is placed on looking at the cost-outomes impact of a new drug or therapy within a systems or disease area framework in which the redistribution of patients between therapy options is explicitly modelled. The guidelines specify that the following information elements be used in pharmacoeonomic analysis: product description, place in therapy, comparator products, therapy intervention framework, supporting clinical data, supporting pharmacoeconomic data, system impact assessments-costs-outcomes, overall assessment, and bibliography and supporting materials.
METHODS: Based on a therapy intervention approach, the guidelines provide a structured framework to help managed care purchasers become more consistent in how they evaluate drug products for inclusion in the formulary. The guidelines factor in the need to examine the impact of new drug products on overall costs within the entire health system.
METHODS: Intended for use by managed care organizations in the U.S. that purchase prescription drugs.
METHODS: Not applicable.
METHODS: Not applicable.
RESULTS: The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population being treated and the fact that patients generally are redistributed among different treatment categories once a new drug product is introduced, thus offering MCOs an analysis model that extends beyond the traditional partial cost-outcomes approach. Emphasis is placed on looking at the cost-outomes impact of a new drug or therapy within a systems or disease area framework in which the redistribution of patients between therapy options is explicitly modelled. The guidelines specify that the following information elements be used in pharmacoeonomic analysis: product description, place in therapy, comparator products, therapy intervention framework, supporting clinical data, supporting pharmacoeconomic data, system impact assessments-costs-outcomes, overall assessment, and bibliography and supporting materials.
摘要：
目的：提出一套指南，供美国卫生保健组织使用，对药品进行比较临床信息和经济分析，以做出合理的药品采购决策。
方法：基于治疗干预方法，该指南提供了一个结构化的框架，以帮助管理式护理购买者在评估纳入处方集的药物产品方面变得更加一致。该指南考虑到需要检查新药产品对整个卫生系统总成本的影响。
方法：适用于购买处方药的美国管理医疗组织。
方法：不适用。
方法：不适用。
结果：该指南为MCO提供了一种新的系统方法，用于确定药物治疗的总体成本和临床结果影响。该指南旨在考虑到接受治疗的患者人群的特征，以及一旦推出新药产品，患者通常会在不同的治疗类别中重新分配的事实，从而为MCO提供了一个超越传统部分成本结果方法的分析模型。重点是在明确建模患者在治疗方案之间的重新分配的系统或疾病领域框架内，研究新药或疗法的成本影响。该指南规定在药理学分析中使用以下信息元素：产品说明，在治疗中，比较产品，治疗干预框架，支持临床数据，支持药物经济学数据，系统影响评估-成本-结果，总体评估,以及参考书目和辅助材料。
方法：基于治疗干预方法，该指南提供了一个结构化的框架，以帮助管理式护理购买者在评估纳入处方集的药物产品方面变得更加一致。该指南考虑到需要检查新药产品对整个卫生系统总成本的影响。
方法：适用于购买处方药的美国管理医疗组织。
方法：不适用。
方法：不适用。
结果：该指南为MCO提供了一种新的系统方法，用于确定药物治疗的总体成本和临床结果影响。该指南旨在考虑到接受治疗的患者人群的特征，以及一旦推出新药产品，患者通常会在不同的治疗类别中重新分配的事实，从而为MCO提供了一个超越传统部分成本结果方法的分析模型。重点是在明确建模患者在治疗方案之间的重新分配的系统或疾病领域框架内，研究新药或疗法的成本影响。该指南规定在药理学分析中使用以下信息元素：产品说明，在治疗中，比较产品，治疗干预框架，支持临床数据，支持药物经济学数据，系统影响评估-成本-结果，总体评估,以及参考书目和辅助材料。
