Health Economics Research Group, Brunel University, Uxbridge, Middlesex UB8 3PPH, UK.
Int J Technol Assess Health Care. 2010 Jan;26(1):79-85. doi: 10.1017/S0266462309990882.
The aim of this study was to describe the current issues surrounding Coverage with Evidence Development (CED). CED is characterized by restricted coverage for a new technology in parallel with targeted research when the stated goal of the research or data collection is to provide definitive evidence for the clinical or cost-effectiveness impact of the new technology.
Presented here is information summarized and interpreted from presentations and discussions at the 2008 Health Technology Assessment International (HTAi) meeting and additional information from the medical literature. This study describes the differences between CED and other conditional coverage agreements, provides a brief history of CED, describes real-world examples of CED, describes the areas of consensus between the stakeholders, discusses the areas for future negotiation between stakeholders, and proposes criteria to assist stakeholders in determining when CED could be appropriate.
Payers could interpret the evidence obtained from a CED program either positively or negatively, and a range of possible changes to the reimbursement status of the new technology may result. Striking an appropriate balance between the demands for prompt access to new technology and acknowledging that some degree of uncertainty will always exist is a critical challenge to the uptake of this innovative form of conditional coverage.
When used selectively for innovative procedures, pharmaceuticals, or devices in the appropriate disease areas, CED may provide patients access to promising medicines or technologies while data to minimize uncertainty are collected.
本研究旨在描述围绕着证据开发覆盖（CED）的当前问题。CED 的特点是在有针对性的研究同时限制新技术的覆盖范围，当研究或数据收集的既定目标是为新技术的临床或成本效益影响提供明确证据时。
本文从 2008 年健康技术评估国际（HTAi）会议的演讲和医学文献中的其他信息中总结和解释了信息。本研究描述了 CED 与其他有条件覆盖协议之间的差异，提供了 CED 的简要历史，描述了 CED 的实际示例，描述了利益相关者之间的共识领域，讨论了利益相关者之间未来谈判的领域，并提出了标准，以帮助利益相关者确定何时 CED 可能是合适的。
支付者可以从 CED 计划中获得的证据进行正面或负面的解释，并且可能会导致新技术的报销状况发生一系列可能的变化。在快速获得新技术的需求和承认始终存在一定程度的不确定性之间取得适当的平衡，是采用这种创新形式的有条件覆盖的关键挑战。
当选择性地用于适当疾病领域的创新程序、药物或设备时，CED 可以为患者提供有前途的药物或技术，同时收集数据以最大程度地减少不确定性。
