EVIDENCE DEVELOPMENT TIMELINE OF MEDICAL DEVICES IN THE UK- WHERE DO MEDICAL INNOVATION BRIEFINGS FIT?
Author(s)
Overhill A1, Chen G2, Upton E2, Peirce VJ2, Marsh W2
1Costello Medical, CAMBRIDGE, UK, 2Costello Medical, Cambridge, UK
OBJECTIVES: MedTech Innovation Briefings (MIBs) are evidence summaries published by NICE for medical device and diagnostic technologies, to support local decision-making. In comparison, Medical Technology Guidance documents (MTGs) and Diagnostic Guidance documents (DGs) are outputs of formal NICE Health Technology Assessment (HTA). Our study objective was to evaluate the evidence included in MIBs vs MTGs/DGs, to better understand how these programmes fit into the evidence development timelines of medical devices and diagnostics. METHODS: The 10 most recent MIBs and 5 most recent MTGs and DGs were reviewed to extract the technology, volume and quality of supporting evidence and CE mark date. All MIBs, MTGs and DGs published before May 2018 were also reviewed to identify any technologies that had been evaluated both in a MIB and a subsequent MTG/DG. RESULTS: Compared to MIBs, MTGs and DGs considered 7.5x (2 vs 15) and 3.0x (2 vs 6) more studies per technology, and 6.3x (465 vs 2,947) and 5.1x (465 vs 2,358) more study participants per technology. Studies were predominantly observational for all programs: 48% (MIBs), 81% (MTGs) and 66% (DGs). MIB publication dates were 1–12 years after CE mark date, whereas the delay between CE marking and MTG/DG publication was 8–21 years. Two technologies were identified as having been reviewed in MIBs and then subsequently evaluated in DGs. The DGs considered additional studies not reported in the MIBs, including studies available at the time of the MIB publication. CONCLUSIONS: In contrast to MTGs/DGs, MIBs are typically published closer to the CE mark date and the volume and quality of evidence considered is less. This suggests that MIBs offer a route in the UK for formal review of earlier stage medical technologies that have a less mature evidence base, and do not preclude subsequent formal HTA.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
MD1
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes, Pricing Policy & Schemes
Disease
Multiple Diseases