NICE's medical technologies advisory committee considered evidence, from several sources, on digital technologies to deliver specialist weight-management services for adults who are eligible for weight-management medicine. This includes an early value assessment (EVA) report by the external assessment group (EAG), and an overview of that report. Full details are in the project documents for this guidance on the NICE website.
3.1 There is an unequal distribution of specialist weight-management services across the NHS, and in some areas there is no access to them. In areas where there are services, there is an increasing number of people on waiting lists because of limited resources and funding. Also, waiting times for accessing services have been rising significantly. The clinical experts estimated that 30% to 70% of people do not have access to a specialist weight-management service in their area. They also estimated that 10% to 30% of people are unable to attend face-to-face appointments because of time commitments or for mental health reasons.
3.2 Limited access to specialist weight-management services may also limit access to weight-management medicine for people who are eligible. Weight-management medicine can only be accessed alongside a programme from a specialist weight-management service. The clinical experts explained that if there are no specialist services available, people may be referred to other tier 1 or tier 2 weight-management services. These services cannot provide or manage weight-management medicine and do not offer appropriate support for treatment with medicine. The clinical experts also said that people who cannot access services may go to private providers that are not regulated and could be harmful because there is no wrap-around support. The clinical experts agreed that there are limited treatment options for people who cannot access specialist services in their area. The committee concluded that there is an unmet need, and access to specialist weight-management services should be improved.
3.3 The evidence suggests that 5 out of the 8 technologies (Gro Health W8Buddy, Liva, Oviva, Roczen and Second Nature) have a potential benefit for adults who are eligible for treatment with weight-management medicine. But only 1 published full-text study included people who were taking weight-management medicine. There was limited evidence for CheqUp and Juniper and no evidence for Wellbeing Way.
3.4 The evidence base consists of 26 studies reported across 31 publications. Four studies for Second Nature were excluded from the EAG assessment report because they were not considered relevant to the decision problem. But these studies were later considered relevant to the assessment by the committee. The evidence included 1 randomised controlled trial (RCT), 4 non-randomised comparative studies, 1 pilot RCT (which did not compare the technology with standard care), 13 non-comparative studies and 7 unpublished studies that were provided by the companies. The EAG explained that comparative evidence reported equivalent or more weight loss when using the technologies compared with face-to-face specialist weight-management services, but that this evidence is limited. The statistical significance beyond 1 year is uncertain, but the evidence suggests equivalence with standard care at 2 years. The evidence generally reported weight loss for the technologies when compared with baseline (for Liva, Oviva, Roczen and Second Nature). The clinical experts agreed that the non-comparative evidence was enough to demonstrate at least equivalent weight loss when the technologies were compared with having no access to specialist weight-management services. The committee heard that longer-term follow up is needed because obesity is a chronic condition.
3.5 There is some evidence on programme adherence, programme engagement, health-related quality-of-life outcomes and psychological outcomes. The RCT for Liva reported no difference in the EQ‑5D‑5L or Short Warwick–Edinburgh Mental Wellbeing Scale scores compared with face-to-face support or with baseline at 6 months and 12 months. The committee concluded that more evidence is needed for these outcomes.
3.6 During consultation, further evidence was submitted for CheqUp, Gro Health W8Buddy, Juniper, Oviva and Second Nature. Gro Health W8Buddy provided an additional poster report on weight loss outcomes and an unpublished paper. The committee concluded that the additional evidence provided was enough to support the use of Gro Health W8Buddy in the NHS while further evidence is generated. Second Nature provided a conference poster of a retrospective cohort study, and Oviva provided an abstract on adverse event data when using Oviva with weight-management medicine. This conference poster and abstract did not change the outcome of the assessment.
3.7 CheqUp submitted a preliminary data summary of an ongoing study using the technology alongside weight-management medicine, and Juniper provided interim results on 2 ongoing studies and details of a third ongoing study. The committee concluded that the evidence provided was not of good enough quality to recommend CheqUp and Juniper for use in the NHS while further evidence is generated, but recommended that further research is done through company, research or non-core NHS funding.
3.8 Further evidence will be generated while 5 technologies (Gro Health W8Buddy, Liva, Oviva, Roczen and Second Nature) are used in the NHS to address the immediate unmet need, with appropriate risk-management processes in place. The clinical experts and committee stressed the importance of clinical risk management. The companies advised that they have risk-management processes and safeguarding systems in place. Most of the technologies have monitoring systems to pick up any key words relating to safety or adverse events, as well as regular contact with healthcare professionals. The committee highlighted that there is a lack of evidence relating to how the technologies monitor and report adverse events, and limited evidence for people taking weight-management medicine. The committee concluded that these technologies can be used, while evidence is generated, as an option to deliver specialist weight-management services to manage weight-management medicine. But they should only be used with appropriate safeguarding and risk-management processes in place.
3.9 The clinical experts raised that there is limited information on how multidisciplinary teams (MDTs) are used in the programmes offered by the technologies. But they noted that this is also the case for standard care and that MDTs can vary significantly between weight-management services. The clinical experts also highlighted that a full clinical assessment and referral for weight-management medicine is needed before using these technologies, to make sure the technologies are suitable. They also noted that the programmes' MDTs must include psychological support because obesity is a complex condition that requires a lot of support. People may have additional co-morbidities and a large proportion of people with obesity have mental health issues. The clinical experts said that it is important to monitor behaviour on restricted diets to minimise the risk of potential harms, such as developing disordered eating. The committee concluded that both psychological monitoring and appropriate referral procedures are important.
3.10 The technologies may not be suitable for everyone. The clinical experts estimated that 7% to 30% of people may find digital programmes unsuitable, for example, because of reduced manual dexterity or a learning disability. They also noted that some people are less comfortable or skilled in using digital technology, or may have limited access to equipment and the internet. Autistic people may also find digital technologies unsuitable or may need additional support. The EAG said that the economic model included costs for a tablet computer and monthly internet access, to reduce the risk of excluding people because of digital inequality. The committee noted that language could also be a barrier to accessing the technologies' programmes. The companies confirmed that most of the technologies offer their programmes in multiple languages. The clinical experts said that there is a lack of evidence available to identify which groups may or may not be able to access the technologies, or who may benefit the most from them. The committee accepted that some people may need additional support or equipment when using the technologies. The committee agreed that NHS teams should consider providing a tablet computer and mobile internet connection when offering these technologies, to reduce digital inequality. It concluded that there may be some people who may not benefit from the technologies, but that more data is needed.
3.11 The preliminary results of the early economic modelling showed that the technologies are cost effective when compared with face-to-face services. The EAG said that there was limited data to populate the parameters of the model, and that the results are uncertain. Based on the sensitivity and threshold analysis, the biggest factor affecting the results is the estimate of standard care costs used for current tier 3 services. The threshold analysis showed that if standard care costs were reduced by approximately 25%, or the technology costs were increased by 35%, then standard care would become the cost-effective option. The committee concluded that further evidence on clinical effectiveness including health-related quality of life and resource use is needed to reduce uncertainty in the cost modelling.
3.12 For 5 technologies (Gro Health W8Buddy, Liva, Oviva, Roczen and Second Nature), the committee agreed that the evidence is limited. It agreed that the key evidence gaps relate to study design and duration, population, comparator, outcomes and decision modelling. The committee concluded that there is enough evidence of potential benefits from the 5 technologies for them to be used in the NHS while further evidence is generated, once they have Digital Technology Assessment Criteria (DTAC) approval. Evidence generation is needed to address the following key evidence gaps:
Study design and duration: there is limited comparative evidence and no long-term evidence beyond 1 year for most of the technologies, apart from a 2‑year study for Liva. The committee and clinical experts highlighted the importance of long-term outcomes to evaluate if weight loss can be maintained.
Population: only 1 published full-text study reported the proportion of people taking weight-management medicine. The clinical experts and committee highlighted the importance of generating evidence in this population to ensure that patient safety is monitored appropriately. There is also a lack of evidence for how different populations, including people who are underserved, engage with the technologies, and which groups may benefit the most.
Technologies: there is limited unpublished evidence relating to the decision problem for CheqUp and Juniper and no available evidence for Wellbeing Way. The committee concluded that further research is needed for these technologies.
Comparator: the number of specialist weight-management service providers and the number of people who use the services in the NHS is not known, with limited data on service delivery and MDT composition. The EAG suggested that the NHS National Obesity Audit could enable these services to be monitored in the future. The committee concluded that it is important to capture MDT composition and service delivery in further evidence generation because it may also impact the cost-effectiveness results.
Outcomes: there is inconsistency in the outcomes reported in the evidence base. The clinical experts highlighted that the evidence base includes self-reported and clinically measured weight-related outcomes, which may introduce bias. The clinical experts agreed that key outcomes should be prioritised to ensure consistency in future evidence generation (see section 1.6). The committee highlighted the importance of measuring health-related quality-of-life and psychological outcomes using patient-reported outcome measures such as the EQ‑5D, SF‑12, SF‑36 or PHQ‑9.
Decision modelling: there is a lack of direct economic evaluations related to all the technologies. The committee concluded that more direct data is needed for both digital weight-management technologies and standard care to reduce uncertainty in future economic modelling.
3.13 The committee concluded that there was not enough clinical-effectiveness evidence to recommend CheqUp, Juniper and Wellbeing Way for use in the NHS, other than as part of a research study. Research should include well-designed and adequately powered studies with appropriate comparators. The key outcomes prioritised by the committee and further important outcomes are outlined in section 1.6. Research studies should address the evidence gaps outlined in this guidance to assess the benefit of using these technologies to deliver specialist weight-management services for adults who are eligible for weight-management medicine.