OBJECTIVES: The NICE Diagnostics Programme recently published draft guidance on technologies designed for remote monitoring of symptoms in Parkinson’s disease (PD). These received conditional recommendation only if, among other conditions, evidence was generated to address specific gaps.

We delivered an Evidence Generation Plan (EGP) for NICE to share with technology developers in this space, under the newly established Early Value Assessment (EVA) approach to assessing digital products, devices and diagnostics.

METHODS: Multi-stakeholder and key opinion leader interviews, technology review and company engagement, systematic review and database search, alternative protocol designs incorporating considerations of NHS data management and linkage, statistical treatment of real-world data and health economic modelling.

RESULTS: Our approach yielded a deep understanding of existing data sources and their limitations, including patient registries unique to PD. The study designs and associated temporal horizons were tailored to the generation of a roadmap that will guide companies in evidence generation over the next 2-3 years. The identification of different use cases for these technologies was a unique challenge associated with this work.

CONCLUSIONS: After the end of the evidence generation period, NICE will review the evidence and decide whether these technologies can be routinely adopted in the NHS. This roadmap is currently under consideration at NICE.