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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    HealthTech draft guidance

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    1 Recommendations

    Can be used with evidence generation

    1.1

    Overcoming Bulimia Online can be used in the NHS during the evidence generation period as an option to treat the following conditions in adults:

    • binge eating disorder

    • bulimia nervosa

    • other specified feeding or eating disorder (OSFED) with similar features to binge eating disorder or bulimia nervosa

    • disordered eating with similar features to binge eating disorder or bulimia nervosa.

      It can only be used:

    • if the evidence outlined in the evidence generation plan for Overcoming Bulimia Online is being generated

    • once it has appropriate regulatory approval including NHS England's Digital Technology Assessment Criteria (DTAC) approval.

    1.2

    Overcoming Bulimia Online should only be used:

    • after an initial eating disorder assessment in primary care or further assessment by specialist eating disorder services

    • alongside usual waiting list care, such as regular check-ins and routine physical monitoring.

    1.3

    The company must confirm that agreements are in place to generate the evidence. It should contact NICE annually to confirm that evidence is being generated and analysed as planned. NICE may revise or withdraw the guidance if these conditions are not met.

    1.4

    At the end of the evidence generation period (2 years), the company should submit the evidence to NICE in a format 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 research is needed

    1.5

    More research is needed on Digital CBTe and Worth Warrior to treat the following conditions before they can be funded by the NHS:

    • binge eating disorder

    • bulimia nervosa

    • OSFED with similar features to binge eating disorder or bulimia nervosa

    • disordered eating with similar features to binge eating disorder or bulimia nervosa.

    What this means in practice

    Can be used with evidence generation

    Overcoming Bulimia Online can be used as an option in the NHS during the evidence generation period (2 years) and paid for using core NHS funding. During this time, more evidence will be collected to address any uncertainties. Companies are responsible for organising funding for evidence generation activities.

    After this, NICE will review this guidance and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs.

    Potential benefits of use in the NHS with evidence generation

    • Access: Unguided digital self-help is a treatment option that can start as soon as an eating problem is identified. This could be in primary care or straight after an eating disorder is diagnosed in a specialist eating disorder service. Digital self-help alongside usual waiting list care provides a greater level of intervention compared with usual waiting list care alone. This is important because early intervention increases the chances that a person makes a full recovery.

    • Clinical benefit: Using digital self-help could improve eating disorder symptoms. Randomised controlled trials show that Overcoming Bulimia Online reduces frequency and severity of eating disorder symptoms compared with usual waiting list care.

    • Resources: Earlier treatment could reduce the demand on or the length of more intensive treatments such as guided self-help and group or individual eating-disorder-focused cognitive behavioural therapy (CBT-ED). Results from the short-term economic modelling show that Overcoming Bulimia Online has the potential to be cost saving even with conservative assumptions about the effects of the technology.

    • Equality: Some people may particularly benefit from having access to unguided digital self-help, for example:

      • people with less severe eating disorders who may otherwise wait longer for treatment

      • people who live in areas where specialist eating disorder service capacity is lower.

    Managing the risk of use in the NHS with evidence generation

    • Patient outcomes: When unguided digital self-help is used alongside usual waiting list care, it is not expected to cause harm to people with eating disorders. Unguided self-help is not intended for people with severe eating disorders or at a high mortality risk.

    • Equality: Some people may find it more difficult to use or engage with digital self-help technologies, for example:

      • neurodivergent people

      • people with learning disabilities

      • people with visual, hearing or cognitive impairments

      • people who have problems with manual dexterity and

      • people who are less familiar with using digital technologies.

    More research is needed

    There is not enough evidence to support funding Digital CBTe and Worth Warrior in the NHS.

    Access to Digital CBTe and Worth Warrior should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.

    What evidence generation and research is needed

    More evidence generation and research is needed on:

    • remission, relapse and mortality compared with usual waiting list care, with digital self-help used as an unguided intervention

    • longer-term remission, relapse and mortality after digital self-help compared with no digital self-help

    • how well the technologies work for people who may find it more difficult to use digital self-help technologies

    • the proportion of people who do not complete the digital self-help, their characteristics and reasons for stopping

    • effects of digital self-help on resource use and the care pathway compared with usual waiting list care.

    Why the committee made these recommendations

    People with eating disorders can face long waits to access specialist assessment and psychological treatment. Earlier treatment can help to stop the condition becoming more severe. Unguided digital self-help is a treatment option that can start as soon as an eating problem is identified in primary care or diagnosed in a specialist eating disorder service.

    When used alongside usual waiting list care, there is a low risk of harm with unguided digital self-help compared with usual waiting list care alone.

    Clinical trial evidence shows that people with eating disorders who use Overcoming Bulimia Online have fewer binge eating episodes and less severe symptoms than people having usual waiting list care.

    Short-term economic evidence suggests that Overcoming Bulimia Online is likely to be cost effective. So it is recommended for use with evidence generation.

    Evidence from observational studies suggests that Digital CBTe and Worth Warrior may also reduce eating disorder symptoms. But this is uncertain because the studies did not compare the technologies with anything else. The study on Worth Warrior is also too small to draw firm conclusions on its clinical effectiveness. Because of the uncertainties in the clinical evidence, it is not possible to say whether Digital CBTe and Worth Warrior are likely to be cost effective. So they are only recommended for use in research.

    More evidence is needed to show how well these technologies work and why some people stop using them. Evidence is also needed to show how using the technologies might affect resource use and the wider care pathway.