Keech M
Global Health Outcomes, GlaxoSmithKline, Greenford, Middlesex, England.
Pharmacoeconomics. 2001;19 Suppl 2:27-31. doi: 10.2165/00019053-200119002-00005.
Within the pharmaceutical industry, there is increasing interest in collecting health outcomes data in order to inform decision-making, both internally and externally. The overall aim of generating the health outcomes information is to determine the value of the product, from the perspective of all the stakeholders. In addition to studies carried out during phase II and III of clinical development, pharmaceutical companies have recently begun to collect health outcomes information earlier, with the expected requirements for reimbursement and market access considered during the preclinical and phase I stages. However, there are a number of challenges to the demonstration of product value during drug development, particularly relating to the limitations of clinical trials. One way that pharmaceutical companies are addressing these challenges is through the use of economic modelling, to provide a framework to test assumptions and assess uncertainty, and examine the budget impact of treatments. Although different countries may use the information differently, health outcomes evidence generated by the pharmaceutical industry is generally used to inform decision-making about pricing, reimbursement, treatment guidelines and inclusion of drugs on formularies. A wide variety of health outcomes information is produced by the industry in order to provide data on product value that are appropriate for the different perspectives of the stakeholders in the healthcare system.
在制药行业，为了为内部和外部决策提供依据，收集健康结果数据的兴趣日益浓厚。生成健康结果信息的总体目标是从所有利益相关者的角度确定产品的价值。除了在临床开发的II期和III期进行的研究外，制药公司最近还开始更早地收集健康结果信息，并在临床前和I期阶段考虑报销和市场准入的预期要求。然而，在药物开发过程中证明产品价值存在诸多挑战，尤其是与临床试验的局限性有关。制药公司应对这些挑战的一种方式是通过使用经济模型，提供一个框架来测试假设、评估不确定性并检查治疗的预算影响。尽管不同国家可能以不同方式使用这些信息，但制药行业产生的健康结果证据通常用于为定价、报销、治疗指南以及药物纳入处方集等决策提供依据。该行业产生了各种各样的健康结果信息，以便提供适合医疗保健系统中不同利益相关者观点的产品价值数据。
