Objectives

NICE’s evidence standards framework (ESF) for digital health technologies (DHTs) describes expected health technology assessment evidence levels for the commissioning of these technologies in the NHS. NICE's medical technologies evaluation programme (MTEP) develops guidance on medical devices and diagnostics which are claimed to be cost saving for the NHS. Medical technologies guidance has been published on 5 DHTs. Here we present a summary of the evidence for each technology and compare it with the evidence levels suggested in the ESF.

Methods

Guidance development for the DHTs was based on the existing NICE MTEP process and methods which aim to evaluate the clinical effectiveness and economic impact of the technology. Consideration of the ESF evidence levels is not part of the existing process. Two reviewers assessed the evidence for each technology published in the NICE committee papers compared with the relevant ESF levels.

Results

The 5 DHT’s with NICE medical technologies guidance include 3 diagnostics, 1 therapeutic and 1 self-management tool.

The clinical evidence available shows that all 5 DHTs reviewed had clinical studies to demonstrate their effectiveness. Most of the technologies had multiple studies with different designs, settings and outcomes. In some cases the studies did not include the appropriate population or comparator or were not of high quality.

In general the economic evidence was weaker and there was uncertainty about the claimed cost savings for some technologies. This was usually related to a lack of knowledge of the resource consequences associated with including the technology in the care pathway.

Conclusions

In general there is good alignment between the suggested evidence levels in the ESF and the evidence available for technologies with NICE guidance. However we noted the guidance development process does not include assessment of a budget impact model as suggested by the ESF.