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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?

Early value assessment consultation document for HTE10056 Digital therapy for chronic tic disorders and Tourette syndrome

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1 Recommendations

Can be used while more evidence is generated

1.1

Two technologies can be used with standard care during the evidence generation period as options for treating chronic tic disorders and Tourette syndrome. The technologies are:

  • Online Remote Behavioural Intervention for Tics (ORBIT; Mindtech) in children and young people 9 to 17 years

  • Neupulse (Neurotherapeutics) in children and young people 12 years and over, and in adults.

    Neupulse is currently working towards CE and UKCA marking (expected 2026). Neupulse can be used once it has appropriate regulatory approval and meets the standards within NHS England's Digital Technology Assessment Criteria (DTAC).

    The technologies can only be used if the evidence outlined in the evidence generation plans is being generated.

1.2

The companies must confirm that agreements are in place to generate the evidence (as outlined in NICE's evidence generations plans). They must contact NICE annually to confirm that evidence is being generated and analysed as planned. NICE may withdraw the guidance for a technology if these conditions are not met.

1.3

At the end of the evidence generation period (about 3 years), the companies should submit the evidence to NICE in a form that can be used for decision making. NICE will review the evidence and assess if the technologies can be routinely adopted in the NHS.

What evidence generation is needed

1.4

More evidence generation in children, young people and adults is needed on:

  • long-term clinical effectiveness

  • the effect of the technologies on quality of life

  • adherence

  • how the conditions progress without the technologies

  • adverse events

  • the impact of long-term effectiveness on long-term costs

  • long-term follow-up costs needed to maintain effectiveness

  • clinical and cost effectiveness within subgroups

  • views on the effects of the technologies from people with tic disorders or Tourette syndrome and their carers.

    The evidence generation plans give further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. They include how the evidence gaps could be resolved through real-world evidence studies.

Potential benefits of use in the NHS with evidence generation

  • Access: Access to diagnosis and treatment options for people with chronic tic disorders and Tourette syndrome is limited because of variations in expertise, and access to and availability of services across the NHS. Digital therapies for chronic tic disorders and Tourette syndrome improve access and offer another treatment option. This could particularly benefit people who need more flexible access to treatment or prefer a digital therapy over face-to-face therapy.

  • Clinical benefit: Clinical evidence suggests that digital therapies may reduce the severity of the symptoms of chronic tic disorders and Tourette syndrome and improve people's ability to function in everyday life.

  • Resources: These technologies may reduce waiting lists and referrals to specialist services.

Considerations

  • Unmet need: Provision of services for chronic tic disorders and Tourette syndrome varies across the NHS. There is a shortage of trained therapists and behavioural therapy is only available at a small number of specialist treatment centres. So, digital therapies could potentially increase access and treatment options and reduce waiting lists.

  • Costs: There is considerable uncertainty associated with the early results from the economic modelling because of the limited evidence. This guidance will be reviewed after 3 years and the recommendations may change. This should be taken into account when negotiating the length of contracts and licence costs.

  • Patient outcomes: Consistent quality-of-life measures should be used.

  • Equality: Digital therapies may not be accessible to everyone. The following groups may be less likely to benefit and may prefer other treatment options:

    • people with limited access to smart devices, laptops or an internet connection or an internet connection

    • people less comfortable with or skilled at using digital technologies

    • people who have difficulty reading or understanding health-related information in English.