Assessment of devices, diagnostics and digital technologies: a review of NICE medical technologies guidance

Background: The Medical Technologies Evaluation Programme (MTEP) of NICE in England aims to evaluate medical devices that are deemed to be cost-saving or cost-neutral and produce medical technology guidance (MTG) to encourage their adoption. Objective: To review the MTGs since MTEP’s inception in 2009 until February 2017. Methods: One researcher assessed all published MTGs and extracted data on the clinical and economic evidence supporting each technology. The NICE Committee’s decision outcome for each assessment was also recorded. A qualitative analysis was performed on technologies that were not supported for adoption to identify the main drivers of the decision. Results: 31 MTGs were reviewed. The committee fully supported the medical devices in 14 MTGs, 11 were partially supported and 6 not-supported. 58% of the MTGs had no RCT data available and the main source of evidence came from non-experimental studies. There was no statistically significant difference in the average number of RCTs and non-experimental studies between the fully supported, partially supported and not supported technologies. Whilst all the fully supported MTGs demonstrated cost-saving results only 50% of the not-supported MTGs did. The sponsor estimated a higher average cost-saving than the EAC in most of cases (20/31). The qualitative evaluation suggests that the main drivers for negative decisions were the quantity or quality of studies, and cost incurring results in the economic evaluation. Conclusions: The main drivers of the decision-making process are the quality and quantity of the submitted evidence supporting the technologies, as well as the economic evaluation results.