Digitally enabled technologies to support treatment with weight-management medication in specialist weight-management services: early value assessment

Unmet need

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. The clinical experts estimated that 30% to 70% of people do not have access to a local specialist weight-management service. They also estimated that 10% to 30% of people are unable to attend face-to-face appointments because of time commitments or mental health reasons.

3.2 Limited access to specialist weight-management services may also limit access to weight-management medication for people who are eligible. Weight-management medication can only be accessed alongside a specialist weight-management programme. The clinical experts explained that if there are no specialist services available, people may be referred to other weight management services in tier 1 or 2. These services cannot provide weight-management medication and do not offer appropriate support for treatment with medication. They 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.

Clinical effectiveness

3.3 The evidence suggests that 4 out of the 7 technologies (Liva, Oviva, Roczen and Second Nature) have a potential benefit for adults who are eligible for treatment with weight-management medication. But only 1 published study included people who were taking weight-management medication. There was limited evidence for Gro Health W8Buddy which did not include clinical outcomes, and no evidence for CheqUp and 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 (that 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 there was limited comparative evidence that reported more weight loss when using the technologies compared with face-to-face specialist weight-management services. The statistical significance beyond 1 year is uncertain, but the evidence suggests equivalence 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 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.

Risk management

3.6 Further evidence will be generated while 4 technologies (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 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 medication. The committee concluded that these technologies can be used as an option to support weight-management medication, if they are used with appropriate safeguarding and with risk-management processes in place, while evidence is generated.

3.7 The clinical experts raised that there is limited information on how multidisciplinary teams (MDTs) are used in the programmes. 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 medication is needed before using these technologies, to make sure they 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 have mental health issues. They 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.

Equality considerations

3.8 The technologies may not be suitable for everyone. The clinical experts estimated that 7% to 30% of people may find digitally enabled programmes unsuitable, for example, because of reduced manual dexterity, a learning disability, or less digital knowledge or access to equipment and the internet. The EAG said that the economic model included costs for a tablet computer and monthly internet access, to reduce excluding people because of digital inequality. The committee noted that language could also be a barrier to accessing the programmes. The companies confirmed that most of the included technologies offer the 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 programmes and 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.

Costs and resource use

3.9 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 are reduced by approximately 25%, or the technology costs are 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.

Evidence gap review

3.10 For the technologies with available weight-loss evidence (Liva, Oviva, Roczen and Second Nature), the key evidence gaps relate to study design and duration, population, comparator, outcomes and decision modelling. The committee concluded that the evidence is limited, and that evidence generation is needed to address the following key evidence gaps: