Digital therapy for chronic tic disorders and Tourette syndrome: early value assessment

1 Purpose of this document

NICE's assessment of digitally enabled therapy for chronic tic disorders and Tourette syndrome considered the Neupulse technology. This plan outlines the evidence gaps and what data needs to be collected for a future NICE recommendation about the use of the technology in the NHS. It is important that evidence generation is aligned with how the technology could be used in the NHS in the future: under the supervision of a healthcare professional following a formal diagnosis.

NICE has produced a separate evidence generation plan for the Online Remote Behavioural Intervention for Tics (ORBIT) technology.

This plan is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. For assessing comparative treatment effects, well-conducted randomised controlled trials are the preferred source of evidence if these are able to address the research gap.

The developer is responsible for ensuring that data collection and analysis takes place.

Neupulse is included in this early value assessment but is awaiting CE and UKCA marking approval. It is estimated that it will be available in 2026, so it cannot be used or included in the NICE recommendations at this time. NICE is publishing the evidence generation plan before regulatory approval has been granted and a NICE recommendation is made. This is to support the planning and design for further evidence generation in anticipation of regulatory approval. NICE will withdraw any subsequent recommendation in the guidance if the developer does not meet the conditions in section 4 on monitoring.

After the end of the evidence generation period (3 years), the developer should submit the evidence to NICE in a form that can be used for decision making. NICE will review all the evidence and assess whether the technology can be routinely adopted in the NHS.