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  • Question on Document

    Are there any additional implementation factors that need to be considered, for example for the technologies, or for the design of the proposed evidence collection?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Evidence generation plan

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1 Purpose of this document

NICE's assessment of digital technologies for providing specialist weight-management services recommends that further evidence is generated for 7 technologies (Counterweight, Gro Health W8Buddy, Liva, Oviva, Roczen, Second Nature and Weight Loss Clinic) while they are being used in the NHS. Five other technologies 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.

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, bringing analytical partners and implementation sites together with companies for evidence generation.

The Department of Health and Social Care's Office for Health Improvement and Disparities has also announced a 2\u2011\year pilot programme evaluating service delivery models to support access to weight-management medicine. NHS England will deliver the programme, with analytical partners commissioned by the National Institute for Health and Care Research. The programme may support evidence generation for technologies adopted through NHS England's procurement process.

Guidance on commissioning and procurement of the technologies will be provided by NHS England, who is developing a digital health technology policy framework to further outline commissioning pathways.

NICE will withdraw the guidance if the companies do not meet the conditions in section 4 on monitoring.

After the end of the evidence generation period (4 years), companies should submit their evidence to NICE in a form that can be used for decision making. NICE will review all the evidence and assess whether the technologies can be routinely adopted in the NHS.