EARLY VALUE ASSESSMENT PROGRAMME

Unmet need

3.1 Provision of services for musculoskeletal-related pain varies across the NHS. Most non-specific LBP is managed in primary or community care settings, which has limited workforce capacity and resources to meet the growing demand for services. The clinical experts noted that there is often a long waiting list for referral to specialist services and that people are likely to try to resolve pain on their own before seeing the GP.

3.2 Digital technologies for managing non-specific LBP that are suitable for self-referral would provide people with the resource they need to self-manage. One clinical expert noted that there was no evidence about people who self-referred. But, in practice, healthcare professionals will want to use digital technologies to ease the strain on resource use.

Implementation

3.3 Some of the technologies included in this assessment are used in the NHS. The committee stated that technologies designed to interact with GP systems ensure continuity of care by making important information accessible to healthcare professionals that need it. The companies for ACT for PAIN, getUBetter, Hinge Health and Pathway through Pain confirmed that their technologies are designed, or will be, to be able to interact with existing NHS systems.

Patient considerations

3.4 Digital technologies can provide quicker access and increase management options for people with non-specific LBP. The patient experts said that quicker access to support can lead to faster improvement in symptoms and can reduce the possibility of acute pain developing to chronic pain. They noted that following a personalised exercise and movement plan could improve mobility, ability to manage pain and mood, and give a sense of control over the condition.

3.5 Patient experts said that reassurance is needed that personal data will be secure. There also need to be appropriate measures in place for reporting adverse events related to using the technologies. They noted that people who are less comfortable or skilled at using digital technology, or unable to read or understand health-related information (including people who cannot read English) need considering. Appropriate alternative support should be provided for them.

3.6 The patient experts advised that patient choice should be a key consideration. They added that people should have the option to remain on a waiting list for a face-to-face appointment if they agree to engage with digital technologies.

3.7 The committee concluded that patient choice and preferences should be taken into consideration when deciding the suitability of digital technologies for managing non-specific LBP. It also noted the importance of codesigning digital technologies with people with LBP. This is to ensure that the content and management options are appropriate and relevant for the users. The companies for ACT for PAIN, getUBetter, Hinge Health and Pathway through Pain said that they have involved people with LBP and healthcare professionals in the development phase of their technologies.

Clinical effectiveness

3.8 The EAG prioritised 12 studies for assessment: 5 randomised controlled trials (RCTs), 1 prospective single-arm trial, 1 prospective cohort study (providing non-comparative data), 2 retrospective cohort studies (providing non-comparative data) and 3 retrospective case series. Only 2 of the studies were done in the UK and 2 other studies included UK participants. The EAG noted that there was considerable uncertainty about the generalisability of the evidence to the UK NHS setting. It stated that there was limited clinical and economic evidence for acceptance and commitment (ACT) therapy in the UK and no studies using ACT for PAIN were identified. The committee noted that there was no evidence of harm or safety concerns. So, it recommended using ACT for PAIN, getUBetter, Hinge Health, Kaia, Pathway through Pain, selfBACK and SupportBack in the NHS while more evidence is being generated. For the other 2 technologies (Ascenti Reach and Phio Engage), there was no evidence or company engagement, so the committee recommended their use only in research.

3.9 The evidence from the prioritised studies reported on 47 different outcomes, including function, pain self-efficacy, intervention adherence and adverse event. The EAG suggested the evidence showed that when compared with standard care alone, digital technologies used with standard care may be effective in terms of improving pain and physical function outcomes. But the range of outcome measures used across the trials made it difficult to compare the digital technologies. Evidence was also limited to short-term effect, with no comparative data for outcomes beyond 3 months. The committee noted that there was no evidence to suggest that technologies were unsafe. It advised that standardised data be collected for future evaluation.

3.10 The committee noted that clinical evidence showed variability in the way adherence was measured and the reported levels of engagement. The clinical experts stated that reported adherence levels were similar to that seen in clinical practice. It was informed that, because of the recurrent nature of LBP, people might stop using a technology when their symptoms improve but use it again if symptoms return. A patient expert said that using digital technologies might be fairly new to people, and that they might experience some challenges. The committee acknowledged that significant effort is needed from people with LBP to complete exercise programmes. It said that the companies should ensure that nudging features are in place to prompt people to engage with the technologies. The committee concluded that more evidence is needed on short-term (30 days) and long-term (6 to 12 months) adherence rates.

Equality considerations

3.11 Digital technologies for managing non-specific LBP may not be suitable for everyone, including people who:

The committee concluded that face-to-face treatment options should be available when digital technologies are not suitable, and companies should consider providing translations.

Costs and resource use

3.12 Early economic modelling using a simple cost-utility model suggested that digital technologies for managing non-specific LBP may be cost effective when used alongside standard care. Base-case results showed the technologies alongside standard care were cost saving by an estimated £84 per person, with a quality-adjusted life year (QALY) gain of 0.01 compared with standard care alone. This was using a threshold of £20,000 per QALY. The analyses were done using an NHS and personal social services perspective. The base-case results were supported by sensitivity and scenario analyses. The economic model used a 1‑year time horizon because of uncertainty in the long-term treatment benefits and the risk of pain relapses, particularly for people with chronic LBP.

3.13 The EAG acknowledged that, because of limited evidence, the model did not have a specific placement in the clinical pathway and that different placement may lead to different reported outcomes. The model included costs of the technologies, healthcare professional time, other health services use and medication. The details of the assumptions used in the model are outlined in table 8.2 of the assessment report on the NICE website. The EAG noted that the main drivers of the model were the cost of the technology, incremental utility, proportion of people engaged with the technology, reduction in physiotherapy referral and number of physiotherapy appointments after referral. The EAG excluded training and implementation costs from the model because of uncertainty in the level of resource use needed.

3.14 The committee noted that the evidence informing the cost model was limited but that there was plausibility of cost effectiveness. It concluded that it was appropriate to recommend some technologies for conditional use within the NHS while more evidence is being generated.

Evidence gap review

3.15 No evidence was identified for Ascenti Reach, ACT for PAIN or Phio Engage. For the remaining technologies, evidence gaps were identified in population demographics, clinical effectiveness, treatment adherence and healthcare resource use. The committee concluded that there was some evidence of potential benefit to support recommending 7 of the digital technologies for managing non-specific LBP in the NHS with evidence generation, once appropriate regulatory approval is in place. The key evidence gaps were: