The National Institute of Health and care Excellence (NICE) produces guidance about whether medical technologies (which include but are not limited to digital therapies) should be adopted into the NHS. The evidence base for this guidance is evaluated in one of three routes, which cover the product life-cycle:
- the NICE Multi-tech guidance (MTG programme),
The aim of all three routes is to evaluate whether a given medical technology is clinically and cost-effective enough to justify a NICE recommendation for conditional (NICE EVA), full (NICE MTEP or NICE HTA), or continued NHS use (NICE LSA).
Each NICE EVA evaluates a single medical technology, whereas a NICE MTG or NICE LSA assesses multiple digital therapies that address the same NHS need or priority topic. In the latter two routes, all candidate technologies are compared. Guidance is then issued at medtech category level and may include a ranking of available technologies overall or by use case.
Requirements and Evidence
There are mMinimal shared requirements for all three routes. These are that an individual digital therapy must have:
- have obtained regulatory approval (i.e. be UKCA marked and be registered with the MHRA as medical device),
- complied with NHS Digital Technology Assessment Criteria (DTAC),
- complied with device-relevant criteria of the NICE Evidence standards framework (ESF) for digital health technologies,
- have documented: clinical evidence, economic evidence, usability evidence, and implementation evidence
Evidence standards vary between routes and are least stringent for NICE EVAs, middling for the NICE MTG programme, and most stringent for NICE LSAs. Evidence should be provided in terms of a Clinical Evaluation Report that should have been started at the conception stage of the digital therapy and must be maintained and updated throughout the product life cycle.
Health Economic evidence should be provided in a parallel Economic Evaluation report. There is currently no detailed guidance or templates available for for the NICE MTG programme. The evidence base required for the NICE MTG programme overlaps substantially with the NICE Technology Appraisal route, although requirements are more proportionate/lenient. It might therefore be best to use the Company Evidence submission template with associated user guide provided under by the NICE HTA scheme until tailored NICE MTG guidance is published.
Developers of digital therapies should register for the NHS Innovation service to ensure maximum visibility of their product for NICE selection and to obtain practical help and support. It is possible to self-nominate a digital therapy for a specific evaluation route (subject to eligibility criteria), but the ultimate decision lies with NICE as evaluator.
Three routes of evaluation and guidance
Below is more information on the three routes
NICE evaluates digital health technologies for use in the NHS and social care system using a transparent, published evidence standards framework (ESF), which has an associated user guide. The NICE ESF is designed to complement evolving MHRA regulation and guidance for software and artificial intelligence as medical device in much the same way as the NHS Digital Technology Assessment Criteria (DTAC). The NHS DTAC sets out clinical safety, data protection, technical assurance, interoperability, and usability and accessibility standards for any digital technologies considered for adoption. NHS England provides a DTAC template with incorporated guidance for developers.
Not all digital technologies are digital health technologies, but all digital health technologies are digital technologies, and all digital therapies are digital health technologies (i.e. the NHS DTAC applies to all digital therapies).
The NICE ESF focusses on clinical- and cost-effectiveness of digital health technologies which may or may not be classed as medical devices. Not all digital health technologies are medical devices, but all digital therapies are digital health technologies AND medical devices because they claim therapeutic effect which means NICE ESF applies to all digital therapies). There are 21 NICE ESF standards, which fall into one of five categories:
- Design factors (standards 1 to 9, e.g. technical safety and reliability),
- Describing value (standards 10 to 13, based on the digital therapies’ value proposition), Demonstrating performance (standards 14 to 16),
- Delivering value (standards 17 and 18), and
- Deployment considerations (standards 19 to 21).
Guidance how to meet each ESF standard is available. Which standards apply to a given digital therapy depends on its potential risk to health and social care service users and to the health and social care system overall. Risk classification guidance is provided; and most digital therapies will fall into Tier C. Note that NICE ESF risk classification is distinct from MHRA medical device classes, but the two systems are designed to map onto each other (see Section B, Table 2).
The NICE EVA for medtech programme is relatively new (initiated 2022, first completion 2023) and its evaluation process is still under development. The programme is designed to enable earlier access to innovative technologies that have the potential to either address an unmet health and social care need, or to offer substantial patient benefit, or to address NHS priorities (currently: cardiovascular disease, mental health, early cancer detection, and boosting system capacity); but require further evidence generation before being eligible for full NICE assessments (e.g. NICE MTEP, NICE HTA).
At the NICE EVA stage, it is generally sufficient to provide preliminary evidence based on existing clinical, economic, usability, and implementation data relevant to the device, and from small-scale studies and estimates (e.g. for cost-effectiveness) with the device itself.
Digital therapies that are accepted into NICE EVA (target time-frame: 6 months) will be conditionally recommended for NHS use. During this early NHS adoption phase, NICE and NHS England will work with the developers to create an evidence generation plan to address gaps. NHS England may even provide funding for pilot and implementation studies.
NICE EVAs produce real-world evidence, which means they generate data for a given digital therapy during health and social care delivery rather than in randomised controlled trials. NICE’s real-world evidence framework provides in-depth guidance and tools for evidence collection. NICE, NHS England and the Department of Health and Social Care (DHSC) actively identifies eligible technologies for its EVA programme, but developers can also self-nominate their digital therapy subject to meeting the eligibility criteria. After a digital therapy has successfully completed a NICE EVA (which is expected to take 2–3 years), it will generally be moved on to a full evaluation via the NICE MTG programme whose outcome will provide a final decision on NHS adoption.
As the name suggests, the new NICE LSA for medtech programme (launched October 2023) applies to health technologies that are already in use within the NHS, but have either never been formally assessed for cost-effectiveness, or require re-assessment against advanced versions or available alternatives.
Like the NICE Multi-tech guidance (MTG) programme, the NICE LSA programme issues a recommendation for NHS adoption or discontinuation at category level, and may provide a ranking of available technologies overall or by use case. For the first LSA round, the Department of Health and Social Care has selected 8 topics that exclusively apply to physical health technologies (transcatheter aortic valve implantation [TAVI], colostomy bags, drug-eluting coronary stents, topical antimicrobial dressings, compression dressings, intermittent catheters, beds, slide sheets). Digital therapies who came under more stringent medical regulation are unlikely to be selected for NICE LSA until they have become more mature technologies with routine adoption into the NHS.
