Oostenbrink Jan B, Koopmanschap Marc A, Rutten Frans F H
Institute for Medical Technology Assessment, Erasmus University Rotterdam, 3000 DR Rotterdam, The Netherlands.
Pharmacoeconomics. 2002;20(7):443-54. doi: 10.2165/00019053-200220070-00002.
The lack of a uniform costing methodology is often considered a weakness of economic evaluations that hinders the interpretation and comparison of studies. Standardisation is therefore an important topic within the methodology of economic evaluations and in national guidelines that formulate the formal requirements for studies to be considered when deciding on the reimbursement of new medical therapies. Recently, the Dutch Manual for Costing: Methods and Standard Costs for Economic Evaluations in Health Care (further referred to as "the manual") has been published, in addition to the Dutch guidelines for pharmacoeconomic research. The objectives of this article are to describe the main content of the manual and to discuss some key issues of the manual in relation to the standardisation of costs. The manual introduces a six-step procedure for costing. These steps concern: the scope of the study;the choice of cost categories;the identification of units;the measurement of resource use;the monetary valuation of units; andthe calculation of unit costs. Each step consists of a number of choices and these together define the approach taken. In addition to a description of the costing process, five key issues regarding the standardisation of costs are distinguished. These are the use of basic principles, methods for measurement and valuation, standard costs (average prices of healthcare services), standard values (values that can be used within unit cost calculations), and the reporting of outcomes. The use of the basic principles, standard values and minimal requirements for reporting outcomes, as defined in the manual, are obligatory in studies that support submissions to acquire reimbursement for new pharmaceuticals. Whether to use standard costs, and the choice of a particular method to measure or value costs, is left mainly to the investigator, depending on the specific study setting. In conclusion, several instruments are available to increase standardisation in costing methodology among studies. These instruments have to be used in such a way that a balance is found between standardisation and the specific setting in which a study is performed. The way in which the Dutch manual tries to reach this balance can serve as an illustration for other countries.
缺乏统一的成本核算方法通常被视为经济评估的一个弱点，它阻碍了研究的解释和比较。因此，标准化是经济评估方法学以及国家指南中的一个重要话题，这些指南为决定新医疗疗法的报销时所考虑的研究制定了正式要求。最近，除了荷兰药物经济学研究指南外，还出版了《荷兰成本核算手册：医疗保健经济评估的方法和标准成本》（以下简称“手册”）。本文的目的是描述手册的主要内容，并讨论与成本标准化相关的手册的一些关键问题。手册介绍了一个六步成本核算程序。这些步骤包括：研究范围；成本类别的选择；单位的确定；资源使用的计量；单位的货币估值；以及单位成本的计算。每个步骤都包含一些选择，这些选择共同确定了所采用的方法。除了对成本核算过程的描述外，还区分了关于成本标准化的五个关键问题。这些问题是基本原则的使用、计量和估值方法、标准成本（医疗服务的平均价格）、标准值（可在单位成本计算中使用的值）以及结果报告。在支持新药品报销申请的研究中，必须按照手册中定义的基本原则、标准值和结果报告的最低要求来使用。是否使用标准成本以及选择特定的成本计量或估值方法，主要由研究者根据具体的研究背景来决定。总之，有几种工具可用于提高研究之间成本核算方法的标准化。必须以在标准化和进行研究的特定背景之间找到平衡的方式来使用这些工具。荷兰手册试图实现这种平衡的方式可以为其他国家提供一个例证。
