Assessment of Devices, Diagnostics and Digital Technologies: A Review of NICE Medical Technologies Guidance.

Abstract

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. To review the MTGs since MTEP's inception in 2009 until February 2017. 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. Thirty-one MTGs were reviewed. The committee fully supported the medical devices in 14 MTGs, 11 were partially supported and six were not supported. Of the MTGs, 58% 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 the cases (20/31). The qualitative evaluation suggests that the main drivers for negative decisions were the quantity or quality of studies, and costs incurred in the economic evaluation results. 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.