In March 2019, NICE published revised Evidence Standards Framework for Digital Health Technologies for businesses aiming to supply the NHS. The updated version includes greater guidance and more examples to help applicants, however possibly still not enough detail to build a business plan around it.
It is remarkable that the business model of so many healthtech technologies in the UK avoids the NHS. Instead of confronting the perils of reimbursement that mar the pharmaceutical sector, healthtech developers seem to focus on going directly to users/patients who download from an app store.
However, the UK Government is keen for that to change. In March 2019, the National Institute for Health and Care Excellence (NICE) published an updated set of standards for digital health technologies (DHT) (DHT guidance) for businesses looking make their services available via the NHS (i.e. get "commissioned") – either because of the complexity of the technology, or to address health inequalities. The standards were first published in December 2018 to accelerate the uptake of products like healthcare apps and wearable devices across the NHS. Note, however, that these standards are not intended for DHTs incorporating AI that uses adaptive algorithms (but AI using fixed algorithms is covered).
How to get commissioned
For a new type of technology to get "commissioned" so that it is available via the NHS, it must pass evaluation by NICE. This is different from the CE marking process. The aim of CE marking is to ensure that the technology is safe and effective; to pass the NICE evaluation, it must also justify the expense to the payer (i.e. the NHS). Whilst the CE mark establishes a common standard across the European Economic Area, whether or not a technology will be paid for out of the public purse is a matter for each Member State.
In the UK, NICE will assess whether the product is (1) effective and (2) good value for money, so that it makes sense for it to be paid for by the taxpayer via NHS commissioning. The new DHT guidance set out what evidence is required to meet these two criteria.
Evidence of effectiveness
To determine what evidence is needed to demonstrate effectiveness to NICE, the technology must first be allocated to a NICE risk tier, based on its functionality.
When considering effectiveness, NICE defines risk as the chance of harm coming to the service user from using the technology. Higher risk of harm means higher NICE tier, means higher requirements for evidence of effectiveness.
The DHT guidance sets out 4 risk tiers, based on functionality:
- Tier 1: System services (e.g. electronic prescribing)
- Tier 2: Inform (e.g. encyclopaedias), Simple Monitoring (e.g. fitness wearables) and Communication (e.g. instant messaging) services
- Tier 3a: Preventative Behaviour Change (e.g. smoking cessation) and Self-Manage Services (e.g. recording data about condition)
- Tier 3b: Treat (e.g. treatment of depression), Active Monitoring (e.g. linked to implants), Calculate (e.g. clinical calculation tools), Diagnose services (e.g. diagnosing diabetes)
If your technology has a number of functionalities, the highest risk function should be used to define its risk classification. Evidence tiers are cumulative, for example, a DHT in tier 3a must meet the standards for tier 1, tier 2 and tier 3a; a DHT in tier 3b must meet the standards for tier 1, tier 2 and tier 3b.
For each risk tier, NICE provides a list of requirements (in the guidance they are called "evidence categories"), which must be met by producing evidence (e.g. acceptability with users), and a minimum evidence standard as well as the best practice standard to meet them. To decide, which of these two standards need to be followed, contextual questions are provided in the DHT guidance to see if the technology poses any specific risks in relation to each requirement. If no specific risk is identified in relation to that requirement, the minimum standard can be used. Otherwise, the best practice standard must be applied. The updated standards provide more explanatory and contextual information and include a new supporting information pack which provides examples of DHTs with different functions, showing where these fit against the functional classification.
Evidence of economic impact
To determine what evidence needs to be produced to NICE to demonstrate good value for money:
- Identify key economic information for the technology, i.e. user population size, current and proposed care pathways, and parameters for the economic model
- Carry out an appropriate economic analysis. DHT guidance sets out three possible levels of economic analysis: Low, Medium and High, depending on the financial consequences of adopting and implementing the DHT from the payer's (i.e. the NHS') perspective, e.g. amount of upfront investment, or need for reorganisation or disruption of existing services. For example, to carry out a pilot study, the level of economic analysis will typically be Low, but it will be High for national commissioning of a cost-incurring DHT. The DHT guidance provides examples and outputs of what is an appropriate analysis for each level.
- Use the Economic analysis reporting standards, when reporting findings of the economic analysis.
Also included in the update is a guide to using the evidence for economic impact standards and a budget impact tool.
One of the trends we observed when advising developers of technologies which are currently available from the app store, is that they often have the ambition of servicing the NHS in the future. For businesses which share this ambition, or investors considering which technologies are well placed for uptake at scale, the DHT guidance is a key tool in approaching this subject. However, pending further guidance, any business plan that tries to incorporate this guidance, will need to build in quite big assumptions regarding the 'specific' risk analysis of the effectiveness component, and the level of economic analysis that would be accepted by NICE.
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