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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?

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

Longer-term data on the clinical impact of ORBIT

Further information about the long-term impact of ORBIT is needed to support health-economic modelling and reduce uncertainty in projections to distant time horizons. To supplement existing data, outcomes should be collected at a minimum of 3 and 6 months after the intervention and ideally up to 24 months.

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 the impact of the technology on services, for example those provided by local specialist clinics (including 'e-coach' time) and carers. This could free up resources that could be used to increase access to treatment or reduce waiting times.

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2.2 Evidence that further supports committee decision making

Clinical and cost effectiveness in different subgroups

There is limited evidence for subgroups of children and young people with diagnosed comorbidities, including:

  • attention deficit hyperactivity disorder

  • obsessive-compulsive disorder

  • autism spectrum disorder

  • mood disorders and

  • anxiety.

More information is also needed on the efficacy of ORBIT in people who have severe tic disorders, and in people from different ethnic backgrounds. There is no evidence for ORBIT in adults. Evidence on the use of ORBIT in adults would support future assessments on the impact of the technology in this population