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Evidence generation plan

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1 Purpose of this document

NICE's assessment of digitally enabled therapy for chronic tic disorders and Tourette syndrome recommends that more evidence is generated while the Neupulse technology is being used in the NHS. A separate evidence generation plan has been produced for the Online Remote Behavioural Intervention for Tics (ORBIT) technology, which is the other technology that was assessed and is not covered in this plan.

This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technology again in the future. It 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 company is responsible for ensuring that data collection and analysis takes place.

Guidance on commissioning and procurement of the technology will be provided by NHS England, who are developing a digital health technology policy framework to further outline commissioning pathways.

NICE will withdraw the guidance if the company does not meet the conditions in section 4 on monitoring.

After the end of the evidence generation period (about 3 years), the company 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.