DiMasi J A, Caglarcan E, Wood-Armany M
Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts, 02111, USA.
Pharmacoeconomics. 2001;19(7):753-66. doi: 10.2165/00019053-200119070-00004.
This study examines the organisational structure of pharmacoeconomics departments in major pharmaceutical and biotechnology companies, the impediments to optimal use of pharmacoeconomic evaluations by companies and the integration of pharmacoeconomic analysis with research and development decision making.
The heads of the pharmacoeconomics departments of 40 companies were surveyed on the structure of pharmacoeconomics departments in their companies, the roles that pharmacoeconomic analyses are playing in the new drug development decision-making process, and the initiation of pharmacoeconomic studies during the development process for a random sample of their companies' investigational new drugs.
45 department heads from 31 parent companies responded to the survey. The pharmacoeconomics function in pharmaceutical and biotechnology companies is relatively new and growing rapidly. Most pharmacoeconomics department heads preferred a different reporting structure than what they currently have and indicated that the strategic role that pharmacoeconomics can play is not well understood within the organisation. Pharmacoeconomic analyses have been increasingly initiated early in clinical development and have been a factor in clinical trial design and in key decisions made during the development process.
Given the continued emphasis on containing healthcare costs worldwide, demand will increase for evidence that drugs provide good value for the money spent on them. Companies will likely respond not only with more economic evaluations for purchasers, but also with greater use of pharmacoeconomics early in the development process to aid in rationalising key research and development decisions, and in guiding final pricing decisions and reimbursement planning, thereby improving resource allocations.
本研究考察了大型制药和生物技术公司中药效经济学部门的组织结构、公司在最佳利用药效经济学评估方面的障碍，以及药效经济学分析与研发决策的整合情况。
对40家公司的药效经济学部门负责人进行了调查，内容涉及他们公司中药效经济学部门的结构、药效经济学分析在新药开发决策过程中所起的作用，以及在其公司随机抽取的研究性新药开发过程中开展药效经济学研究的情况。
来自31家母公司的45位部门负责人回复了调查。制药和生物技术公司中的药效经济学职能相对较新且发展迅速。大多数药效经济学部门负责人倾向于采用与当前不同的汇报结构，并表示公司内部对药效经济学能够发挥的战略作用了解不足。药效经济学分析在临床开发早期开展得越来越多，并且已成为临床试验设计以及开发过程中关键决策的一个因素。
鉴于全球范围内持续强调控制医疗保健成本，对于药物物有所值的证据的需求将会增加。公司可能不仅会针对购买者开展更多的经济学评估，还会在开发过程早期更多地利用药效经济学来帮助合理化关键的研发决策，并指导最终定价决策和报销计划，从而改善资源分配。
