1 Purpose of this document
NICE's early value assessment of digital technologies for managing low back pain (that is, getUBetter, Hinge Health, Kaia, Pathway through Pain and selfBack) recommends that they can be used in the NHS while more evidence is generated. Ascenti Reach, Digital Therapist, Flok Health, Phio Engage and Joint Academy can only be used in research and are not covered in this plan.
This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technologies again in the future. It is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. For assessing comparative treatment effects, randomised controlled trials remain the preferred source of evidence when these are viable to address the research gap and can be well conducted.
The companies are responsible for ensuring that data collection and analysis takes place. Support for evidence generation will be available through a competitive process facilitated by the Office for Life Sciences, pending business-case approval. This will be in the form of funding for evidence generation consortia, which will bring analytical partners and implementation sites together with companies for evidence generation.
Guidance on commissioning and procurement of the technologies will be provided by NHS England. It is developing a digital health technology policy framework to further outline commissioning pathways.
NICE will withdraw the guidance if the technology companies do not meet the conditions about monitoring evidence generation in section 4.
After the evidence generation period (about 3 years), companies should submit the evidence to NICE in a form that can be used for decision making. NICE will review the evidence and assess whether the technologies can be routinely adopted in the NHS.