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目的:公共项目为美国的药物支出提供了大部分的财政支持。截至目前,仍然没有相关指南来估算由美国公共项目资助的药物的成本。本研究的目的是为估算由美国公共项目支持的药物的成本提供标准,以便将其用于药物经济学评价。方法:本报告由国际药物经济学与结果研究协会(ISPOR)的专项计划——成本-效果分析中药物成本测量的良好研究规范工作组中的美国政府角度即美国医疗保险计划(Medicare)和医疗补助计划(Medicaid)以及其他美国政府支付者角度的专门小组撰写。该小组的任务是对研究者在估算由美国公共项目资助药物的成本时所遇到的方法学及实际问题进行评价,以便提出适用于更透明、更准确和更具一致性的成本计算的标准。结果:该小组提出了以下建议:(1)研究者必须考虑会对由公共项目所支付的药物成本产生影响的管理要求;(2)药物成本必须反映真实的购置成本,包括所有的回扣和折扣;(3)必须确保成本投入的相关透明度;(4)推荐包括公共项目的视角;(5)需要特别关注高成本药物,尤其当某一特殊疾病所用药物占卫生保健支出很大比例时;(6)由于公共项目之间的差异,必须对实际购置成本、实际依从性以及仿制药的可获得性进行敏感性分析。此外还对Medicare和Medicaid提出了特别建议。结论:随着对美国公共项目覆盖政策而进行的药物经济学评价越来越多,必须保证药物成本估算的准确性和一致性。以上建议的执行将允许研究者在药物经济学评价当中使用准确、无偏倚的成本估算。
Purpose: Public programs provide most of the financial support for drug spending in the United States. To date, there are still no guidelines to estimate the cost of drugs funded by U.S. public programs. The purpose of this study was to provide a standard for estimating the cost of drugs supported by public-sector programs in the United States for their use in pharmacoeconomic evaluation. METHODS: This report was prepared in the perspective of the U.S. government in the Good Practice Practice Working Group on the Cost-Effectiveness Analysis of Drugs in Cost-Effectiveness Analysis (ISPOR) Special Program - Medicare and Healthcare Medicaid, and other U.S. government payers. The group’s task is to evaluate the methodologies and practical issues researchers face in estimating the cost of drug-sponsored U.S. public projects in order to propose standards that are more cost-effective, more transparent, accurate and consistent . Outcome: The team made the following recommendations: (1) The researcher must consider the management requirements that will have an impact on the cost of medicines paid by public projects; (2) The cost of medicines must reflect the true acquisition costs, including all rebates and discounts ; (3) the relative transparency of cost inputs must be ensured; (4) the recommendation includes a public project perspective; (5) special attention needs to be given to high-cost drugs, especially when the drugs used in a particular disease account for a large proportion of health care expenditures; 6) Sensitivity analysis of actual acquisition costs, actual compliance and availability of generic drugs must be conducted due to the differences between public projects. In addition, there are special recommendations for Medicare and Medicaid. CONCLUSIONS: As pharmacoeconomic evaluations of public policy coverage in the United States have increased, the accuracy and consistency of drug cost estimates must be assured. The implementation of the above recommendations will allow researchers to use accurate and unbiased cost estimates in pharmacoeconomic evaluation.