How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Document

    Has all of the relevant evidence been taken into account?

  • Question on Document

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Document

    Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Document

    Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?
The content on this page is not current guidance and is only for the purposes of the consultation process.

EARLY VALUE ASSESSMENT PROGRAMME

Closed for comments This consultation ended on at   Request commenting lead permission

1 Recommendations

Can be used in the NHS with evidence generation

1.1 Seven digital technologies can be used in the NHS while more evidence is generated to manage non-specific low back pain in people aged 16 and over. The technologies are:

  • ACT for PAIN (company states CE mark or UKCA not required)

  • getUBetter (company states CE mark or UKCA in place)

  • Hinge Health (company states in process of getting regulatory approval)

  • Kaia (regulatory status unknown)

  • Pathway through Pain (company states CE mark or UKCA in place)

  • selfBACK (regulatory status unknown)

  • SupportBack (regulatory status unknown).

These technologies can be used once they have appropriate regulatory approval and meet the standards within NHS England's Digital Technology Assessment Criteria (DTAC).

1.2 The companies must confirm that agreements are in place to generate the evidence (as outlined in NICE's evidence generations plan), and 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.

1.3 At the end of the evidence generation period (about 3 years), the companies 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 technologies can be routinely adopted in the NHS.

Can only be used in research

1.4 More research is needed on Ascenti Reach and Phio Engage (regulatory status unknown for both technologies) to manage non-specific low back pain in people aged 16 and over.

1.5 Access to the technologies should be through company, research or non-core NHS funding, and clinical or financial risks should be appropriately managed.

Evidence generation and research

1.6 More evidence generation and research are needed on:

  • pain and disability using the same outcome measure (Musculoskeletal Health Questionnaire)

  • quality of life using the same outcome measure (EQ‑5D‑5L)

  • patient characteristics (such as type of back pain and severity)

  • time until return to normal activity

  • treatment adherence, that is, the number of people:

    • using a technology at baseline, 30 days and between 6 months and 1 year

    • who stop using a technology and their reasons for stopping

  • healthcare resource use, including:

    • GP appointments

    • physiotherapy appointments

    • emergency department visits

  • how many people have self-referred for the technology and how many have been referred by a healthcare practitioner

  • the position of the technology in the care pathway

  • patients' views on the effects of the technologies collected using a qualitative survey or through interviews.

Potential benefits of use in the NHS with evidence generation

  • Access: Digital technologies for managing non-specific low back pain provide access to rapid advice and offer another treatment option. They will particularly benefit anyone who needs more flexible access to treatment or prefers a digitally enabled therapy over face-to-face therapy.

  • Clinical benefit: Clinical evidence suggests that digital technologies for managing non-specific low back pain may reduce pain and improve ability to function in everyday life.

  • Resources: These technologies could potentially reduce waiting lists, referrals for physiotherapy and the number of physiotherapy appointments and GP visits, medication use and the need for surgery.

Key gaps in the evidence

  • No clinical evidence was identified for Ascenti Reach, ACT for PAIN, Pathway through Pain or Phio Engage.

  • It is difficult to compare technologies because a wide range of outcome measures were used. Also, some outcomes were not well-reported, such as work productivity, and patient experience and satisfaction.

  • There was limited evidence on how they affect psychological management, quality of life, attendance at emergency departments, and referral rates to other services such as imaging, physiotherapy or surgery.

Overall, more evidence is needed on:

  • the clinical effectiveness of digital technologies for low back pain

  • technology uptake and rate of adherence

  • healthcare resource use.

Considerations

  • Costs: Early results from the economic modelling suggest that the technologies used alongside standard care may be cost effective compared with standard care alone. The potential cost effectiveness or cost saving will be affected by how they are used in the clinical pathway. This guidance will be reviewed within 3 years and the recommendations may change. Take this into account when negotiating the length of contracts and licence costs.

  • Information governance: Local NHS hospitals and trusts should have appropriate information governance policies for using these technologies.

  • Patient outcomes: Consistent quality-of-life measures should be used.

  • Equality: Digitally enabled therapies may not be accessible to everyone. Adults with limited access to equipment or an internet connection, or who are less comfortable or skilled at using digital technologies, are less likely to benefit and may prefer another treatment option.

Comments panel open