Novartis Pharma AG, Global Pricing and Market Access, Basel, Switzerland.
Value Health. 2011 Jun;14(4):608-15. doi: 10.1016/j.jval.2010.11.011.
It is common practice for developers of new health care technologies to engage in early dialogue with the major regulatory agencies; such discussions frequently center around the proposed clinical trial designs to support the registration of new interventions and suggestions on their improvement. Pricing and reimbursement agencies are increasingly using the results from health technology assessments to inform their decision making for new technologies. Such assessments are invariably underpinned by the phase 3 clinical trial evidence which may not provide answers to the key questions. Technology developers are beginning to realize that direct, early dialogue on the evidence requirements of the major pricing and reimbursement agencies, before phase 3 clinical trial designs for their key development compounds have been finalized, may be beneficial. This article reports on the pioneering efforts of one technology developer in seeking early dialogue with seven pricing and reimbursement agencies in five countries globally in 2007-2008 on their likely evidence requirements for a new oral treatment for patients with chronic plaque psoriasis. The pilot project demonstrated that a feasible process of early dialogue could be established, through a face-to-face meeting with prior circulation of a briefing book. Although there was some variation in the advice the similarities far outweighed the differences. More experience of early dialogue needs to be accumulated, involving a wider range of pricing and reimbursement agencies and compounds. The conclusion of this study, however, was that early dialogue can be a worthwhile process for all parties and can lead to a common understanding about evidence development for market access.
对于新医疗技术的开发者来说，与主要监管机构进行早期对话是常见做法；此类讨论通常集中在支持新干预措施注册的拟议临床试验设计上，并提出改进建议。定价和报销机构越来越多地使用卫生技术评估的结果来为新技术的决策提供信息。此类评估始终以可能无法回答关键问题的第 3 阶段临床试验证据为基础。技术开发商开始意识到，在第 3 阶段临床试验设计最终确定之前，直接与主要定价和报销机构就关键开发化合物的证据要求进行早期对话可能会有所裨益。本文报告了一家技术开发商在 2007-2008 年期间与全球五个国家的七个定价和报销机构就其对新的慢性斑块型银屑病患者口服治疗方法的可能证据要求进行早期对话的开创性努力。该试点项目表明，可以通过在面对面会议之前分发简报手册来建立可行的早期对话流程。尽管建议存在一些差异，但相似之处远远超过了差异。需要积累更多早期对话的经验，涉及更广泛的定价和报销机构以及化合物。然而，这项研究的结论是，早期对话对于所有各方都是一个有价值的过程，可以就市场准入的证据开发达成共识。
