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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?

  • Question on Document

    Are there any other relevant ongoing studies that address the evidence gaps?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Evidence generation plan

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2 Evidence gaps

This section describes the evidence gaps, why they need to be addressed and their relative importance for future committee decision making.

The committee will not be able to make a positive recommendation without the essential evidence gaps (see section 2.1) being addressed. The company can strengthen the evidence base by also addressing as many other evidence gaps (see section 2.2) as possible. This will help the committee to make a recommendation by ensuring it has a better understanding of the patient or healthcare system benefits of the technology.

2.1 Essential evidence for future committee decision making

Clinical effectiveness compared with NHS standard care

There is limited evidence on the effectiveness of Neupulse in comparison to standard care. Further evidence should compare Neupulse to psychocoeducation, which the committee agreed should be delivered either through face-to-face or online appointments. Information about the impact that the technology has on people's symptoms should be recorded using the Yale Global Tic Severity Scale total scores.

Clinical impact of Neupulse in different subgroups

The anticipated use of Neupulse is not restricted to people with a clinical diagnosis of tic disorders or Tourettes. Due to the current unmet need for diagnosing these conditions, the technology is likely to be used without a formal diagnosis. Further evidence is needed about the clinical impact and potential adverse effects of the technology in people without a diagnosis. The committee heard that a risk of treating tics was increased anxiety. Further data on adverse events in this population would inform future decisions around the user population.

There is limited evidence on the clinical efficacy of Neupulse in people with severe tic disorders. The committee was advised that tic severity may be more stable in adults than in children and young people, enabling data analyses that could support future decisions around the user population.

Longer-term data on the clinical impact of Neupulse

It is unclear if the technology leads to a clinical benefit beyond 4 weeks. Follow-ups should be a minimum of 3 months after the intervention, and ideally at 6 months. This would improve the data available to populate future health-economic models and reduce uncertainty.

Resource use

More information on how using the technology would affect resource use in the NHS, during and after implementation is needed to help the committee understand the technology's cost effectiveness. Resource estimates should include training costs and the broader impact of the technology on services, for example those provided by local specialist clinics and carers. This could free up resources that could be used to increase access to treatment or reduce waiting times.

2.2 Evidence that further supports committee decision making

Clinical and cost effectiveness in people with comorbidities

There is limited evidence for people with diagnosed comorbidities, including:

  • attention deficit hyperactivity disorder

  • obsessive-compulsive disorder

  • autism spectrum disorder

  • mood disorders and

  • anxiety.

More information about the impact of Neupulse in people with these conditions will support future committee decision making.