Online Remote Behavioural Intervention for Tics (ORBIT; Mindtech) can be used with standard care in the NHS during the evidence generation period as an option to treat chronic tic disorders and Tourette syndrome in children and young people 9 to 17 years. It can only be used if the evidence outlined in the evidence generation plan for ORBIT is being generated.
The company must confirm that agreements are in place to generate the evidence (as outlined in NICE's evidence generation plan). 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.
At 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 the evidence and assess if the technology can be routinely adopted in the NHS.
More evidence generation is needed on:
long-term clinical effectiveness (further analyses)
the technology's effect on quality of life
adherence
how the conditions progress without the technology
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 technology from people with tic disorders or Tourette syndrome and their carers.
The evidence generation plan for ORBIT gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources. It includes 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: Digital therapies 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. ORBIT is only available for children and young people 9 to 17 years and there is currently no evidence for use in adults. 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
people less comfortable with or skilled at using digital technologies
people who have difficulty reading or understanding health-related information in English.