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A successful practical application of Coverage with Evidence Development in Australia: Medical Services Advisory Committee interim funding and the PillCam® Capsule Endoscopy Register

  • Sue P. O'Malley (a1), Warwick S. Selby (a2) and Ernest Jordan (a3)

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Discussion: 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.

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This list contains references from the content that can be linked to their source. For a full set of references and notes please see the PDF or HTML where available.

1. D Gilbert , S O'Malley , W Selby . Are repeat upper gastrointestinal endoscopy and colonoscopy necessary within six months of capsule endoscopy in patients with obscure gastrointestinal bleeding? J Gastroenterol Hepatol. 2008;23:18061809.

4. SP O'Malley . The Australian experiment: The use of evidence based medicine for the reimbursement of surgical and diagnostic procedures (1998–2004). Aust New Zealand Health Policy. 2006;3:3.

5. SD Reed , AM Shea , KA Schulman . Economic implications of potential changes to regulatory and reimbursement policies for medical devices. J Gen Intern Med. 2007:23 (Suppl 1):5056.

7. SR Tunis , DB Stryer , CM Clancy . Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290:16241632.

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International Journal of Technology Assessment in Health Care
  • ISSN: 0266-4623
  • EISSN: 1471-6348
  • URL: /core/journals/international-journal-of-technology-assessment-in-health-care
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