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    Has all of the relevant evidence been taken into account?

  • Question on Consultation

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

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

  • Question on Consultation

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The content on this page is not current guidance and is only for the purposes of the consultation process.

MEDICAL TECHNOLOGIES EVALUATION PROGRAMME

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1 Recommendations

Can be used in the NHS while more evidence is generated

1.1

Seven digital technologies to support self-management of chronic obstructive pulmonary disease (COPD) in adults can be used in the NHS while more evidence is generated. The technologies are:

  • Active+me REMOTE

  • Clinitouch

  • COPDhub

  • Lenus

  • Luscii

  • myCOPD

  • SPACE for COPD (this technology can only be used once it has appropriate regulatory approval).

1.2

The companies or developers of these technologies must confirm that agreements are in place to generate the evidence (as outlined in NICE's evidence generation plan). They should contact NICE annually to confirm that evidence is being generated and analysed as planned. NICE may withdraw the guidance if these conditions are not met.

1.3

At the end of the evidence generation period (3 years during which 1 year of follow-up data will be collected), 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 technology can be routinely adopted in the NHS.

Can only be used in research

1.4

More research is needed on COPDPredict to support self-management of COPD before it can be used in the NHS.

1.5

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

Evidence generation and more research

1.6

Evidence generation is needed on:

  • how well the digital technologies work compared with standard self-management of COPD without digital technologies, which may include face-to-face appointments and monitoring, measuring the following outcomes:

    • health-related quality of life using the EQ-5D

    • respiratory function using the COPD Assessment Test score

    • resource use, including:

      • technology costs including licence fees

      • COPD exacerbation-related costs

      • number of primary care visits

      • number of hospital visits and admissions, and associated costs related to COPD

      • staff time needed to support the service

      • training costs

      • implementation costs

    • uptake rates

    • intervention adherence rates

    • preferences and experiences of people with COPD

    • adverse events

    • COPD exacerbation rate

  • where the technologies are used in the care pathway

  • outcomes in the following subgroups:

    • people living in urban areas compared with people living in rural areas

    • people with a new COPD diagnosis compared with people who have established COPD

    • people recently discharged from hospital after a COPD exacerbation, within 4 weeks of the exacerbation.

      The evidence generation plan gives further information on the prioritised evidence gaps and outcomes, ongoing studies and potential real-world data sources for the technologies listed in section 1.1. It includes how the evidence gaps could be resolved using real-world evidence.

      For more detail on the committee's considerations about the evidence gaps for the technologies in 1.4, see sections 3.11 to 3.16 and sections 3.24 to 3.30.

Potential benefits of use in the NHS with evidence generation

  • Access: When people have exacerbations of COPD symptoms, they generally present to their GP or emergency department. For those who are hospitalised, there is a risk of readmission. The COPD clinical audit from the National Asthma and COPD Audit Programme reports that 23.9% of people are readmitted within 30 days and 43.2% within 90 days after discharge. This highlights the importance of effective self-management to prevent exacerbations and readmissions. A digital technology to support self-management may help people who may not be able to access face-to-face appointments. For example, it may benefit people living in rural areas with limited availability, those unable to travel because of how severe their COPD is, and those who cannot or do not want to take time off work. A digital technology will not replace face-to-face appointments in the care pathway. Offering digital technologies as an option for supported self-management for adults with COPD could improve access, engagement, and adherence to self-management plans.

  • Clinical benefit: Clinical evidence for the technologies suggests that these technologies may improve symptoms of COPD, enhance respiratory function, and reduce exacerbations. There are no safety concerns with using digital technologies for supported self-management. These technologies may address an unmet need for people with COPD who do not have access to face-to-face appointments.

  • Resources: Digital technologies to support the self-management of COPD may be cost saving to the NHS by reducing exacerbations and associated costs, which may involve hospitalisation. But this is uncertain because of the limited evidence base, as there is uncertainty about how effective these technologies may be at reducing these symptoms in practice.

  • Equality: COPD is most common in people aged over 50, with men at higher risk of developing COPD than women. There is a higher prevalence of respiratory diseases in people with lower socioeconomic status, because of the effects of living in deprived areas and higher rates of smoking. Also, people living in deprived areas have a lower life expectancy than the general population. COPD is responsible for 8% of the life expectancy difference in men and 12% of the difference in women. Widening access to digital technologies for supported self-management of COPD may help address some of this inequality, because digital technologies provide self-education and stopping smoking advice.

Managing the risk of use in the NHS with evidence generation

  • Costs: There may be costs associated with implementation, staff training, integration with NHS Patient Medication Record systems such as EMIS, and providing smart devices with an internet connection.

  • Equality: Support and resources may be needed for people:

    • unfamiliar with digital technologies

    • without access to smart devices or the internet

    • with visual, hearing, or cognitive impairment, problems with manual dexterity or a learning disability

    • with a mental health condition

    • with a lower reading ability (including people unable to read English)

    • with cultural, ethnic or religious backgrounds that may affect their opinion on using digital technologies for supported self-management of COPD.