O'Malley Sue P, Selby Warwick S, Jordan Ernest
Medical Intelligence and Macquarie University, New South Wales, Australia.
Int J Technol Assess Health Care. 2009 Jul;25(3):290-6. doi: 10.1017/S0266462309990250.
In August 2002, an application for the listing on the Medicare Benefits Schedule (MBS) of PillCam Capsule Endoscopy (formally M2A) as a diagnostic procedure for obscure gastrointestinal bleeding (OGIB) was made to the Medical Services Advisory Committee (MSAC). As a result of this application, in May 2004 PillCam Capsule Endoscopy was approved with interim funding until April 2007. This funding was conditional on the collection of Australian data on the long-term safety, effectiveness, and cost-effectiveness of capsule endoscopy.
A review was conducted of how the data were collected, the methodological difficulties associated with the collection and analysis of the data, and the outcomes of the data.
The PillCam Capsule Endoscopy Register ran from 2004 to 2007 and amassed data on 4,099 patients forming the largest database on PillCam in the world. Based on these data, in November 2007, MSAC recommended that full public funding be supported under the current MBS Item Number 11820 as capsule endoscopy is as safe as and more effective than comparable diagnostic tests. It is the preferred choice of patients and has the potential to reduce the number and cost of previous investigations.
This form of CED proved to be ideally suited to PillCam Capsule Endoscopy. The PillCam Capsule Endoscopy Register provided data that made it possible to validate assumptions used in the economic modeling in the assessment carried out for MSAC in response to the application for funding.
The use of interim funding requires both risk and cost sharing among the key players: industry, government, the medical profession, and the hospitals. Although the characteristics of PillCam Capsule Endoscopy proved to be suited to data collection, this may not be the case with other emerging health technologies. If interim funding coupled with data collection is to become an effective mechanism for bridging the evidence gap, work needs to be carried out by health technology assessment agencies to provide guidance on the design of registers so that they cater for the unique characteristics of individual procedures.
2002年8月，针对PillCam胶囊内镜检查（原M2A）作为不明原因胃肠道出血（OGIB）诊断程序列入澳大利亚医疗福利计划（MBS）一事，向医疗服务咨询委员会（MSAC）提交了申请。由于这一申请，2004年5月PillCam胶囊内镜检查获得临时资助，有效期至2007年4月。该资助的条件是收集澳大利亚关于胶囊内镜检查长期安全性、有效性和成本效益的数据。
对数据收集方式、数据收集与分析相关的方法学困难以及数据结果进行了综述。
PillCam胶囊内镜检查登记从2004年持续到2007年，积累了4099例患者的数据，形成了世界上最大的PillCam数据库。基于这些数据，2007年11月，MSAC建议在当前MBS项目编号11820下提供全额公共资助，因为胶囊内镜检查与同类诊断测试一样安全且更有效。它是患者的首选，并且有可能减少先前检查的次数和成本。
这种形式的CED被证明非常适合PillCam胶囊内镜检查。PillCam胶囊内镜检查登记提供的数据使得验证在针对MSAC资助申请进行的评估中经济模型所使用的假设成为可能。
临时资助的使用需要关键参与者（行业、政府、医疗行业和医院）分担风险和成本。尽管PillCam胶囊内镜检查的特性被证明适合数据收集，但其他新兴健康技术可能并非如此。如果临时资助与数据收集要成为弥合证据差距的有效机制，卫生技术评估机构需要开展工作，为登记册的设计提供指导，使其适应各个程序的独特特性。
