Early Dialogue Between the Developers of New Technologies and Pricing and Reimbursement Agencies: A Pilot Study
Early Dialogue Between the Developers of New Technologies and Pricing and Reimbursement Agencies: A Pilot Study
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DOI：
10.1016/j.jval.2010.11.011
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发表时间：
2011-06-01
期刊：
影响因子：
4.5
通讯作者：
Mayer, Friedrich Karl
中科院分区：
文献类型：
--
作者：
Backhouse, Martin E.;Wonder, Michael;Mayer, Friedrich Karl
新医疗保健技术的开发人员通常会与主要监管机构进行早期对话;此类讨论通常围绕拟议的临床试验设计进行，以支持新干预措施的注册和改进建议。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他们的新技术决策提供信息。这些评估总是以3期临床试验证据为基础，这些证据可能无法回答关键问题。技术开发人员开始意识到，在其关键开发化合物的3期临床试验设计最终确定之前，就主要定价和报销机构的证据要求进行直接的早期对话可能是有益的。本文报道了一个技术开发者在2007-2008年与全球五个国家的七个定价和报销机构就慢性斑块状银屑病患者新的口服治疗可能的证据要求进行早期对话的开创性努力。试点项目表明，通过事先分发简报的面对面会议，可以建立一个可行的早期对话进程。虽然在建议中有一些变化，但相似之处远远超过了差异。需要积累更多的早期对话经验，让更广泛的定价和偿还机构和大院参与。然而，这项研究的结论是，早期对话对所有各方来说都是一个有价值的进程，可以导致对市场准入证据的发展达成共识。
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.