MTRC has released a White Paper "Evidence Requirements for IVD Tests in NICE HealthTech Evaluations”

Health technology assessment (HTA) plays a key role in market access for medical technologies in England. The National Institute for Health and Care Excellence (NICE) is the main HTA body and is responsible for evaluating diagnostics, devices, and digital tools. 

In July 2025, NICE consolidated three of its former programs - Diagnostics Assessment, Interventional Procedures, and Medical Technologies - into a unified NICE HealthTech Program. This new structure reflects a lifecycle-based approach, but the evidence principles from the previous Diagnostics Assessment Programme (DAP) still inform current evaluations.

This white paper reviews five assessments of IVD diagnostic technologies conducted under NICE’s previous Diagnostics Assessment Programme (DAP) framework. While terminology and processes have evolved with the introduction of the HealthTech Evaluation Programme, these case studies remain highly informative. They offer practical insights into NICE’s evidence expectations and common drivers of recommendation decisions, which continue to shape current evaluation approaches.

These findings can support companies in developing effective evidence generation strategies and navigating market access for similar diagnostic technologies in the UK.

Read more and request a White Paper here.