The Pre-authorisation phase covers development steps before a digital therapy is approved for sale in the UK market. Core steps are the identification of the target population and of the unmet need that will be addressed by the proposed digital therapy.
Unmet clinical and NHS needs are flagged through horizon scanning and demand signalling. This is done at a national level through a team within the NHS Accelerated Access Collaborative that works with a range of stakeholders to identify the research and innovation opportunities that have the potential to transform care in high priority clinical areas, where innovations can make a positive impact for large communities. The process is done in line with the priorities and areas of work of the NHS Long Term Plan
At the local level there are 15 Health Innovation Networks (HINs) in the UK that identify innovation and improvements to specific problems for local areas. These agencies work together on the Innovation for Healthcare Inequalities Programme (InHIP), which adopts the national Core20Plus5 approach. Core20Plus5 supports ICSs to manage healthcare inequalities by managing research in five priority clinical areas: maternity, mental health, respiratory disease, cancer diagnosis, and cardiovascular disease.
Required outputs of the Pre-authorisation phase
- A clear definition of the intended target population for the proposed digital therapy, including an evidence-based specification of the incidence and prevalence rates of the condition that the therapy plans to address. For digital therapies aiming to be adopted in specific trusts, incidence and prevalence rates should reflect the geographic area.
- Equity considerations and bias mitigation relevant and specific to the identified target population. This should generally be supported by current NHS data and co-produced with lived experience advisors. More general equity considerations for digital therapies are covered in an NHS England
- A clear exposition of the best practice care that is currently recommended for this target population, generally based on National Institute for Health and Care Excellence (NICE) guidance.
- A clear definition of the unmet need(s) that will be addressed. As with equity considerations this should be supported by current NHS data and co-produced with lived experience advisors.
- A clear explanation how the proposed digital therapy could theoretically improve the identified unmet need(s). This explanation will involve the identification and selection of existing evidence of clinical effectiveness. Ideally, evidence should be identified through a systematic literature review; and selection of evidence should be based on a Levels of Evidence framework. The quality of evidence should be assessed (as a minimum for risk of methodological bias at study-level, ideally additionally across all available evidence using the Grading of Recommendations Assessment, Development and Evaluation [GRADE]).
- A value proposition for investors, purchasers, providers, and people affected by the identified unmet need which goes beyond direct patient benefits in terms of cost-effectiveness etc.
- A care pathway analysis, which describes the typical journey of an individual in the target population with the identified unmet need through the health and social care system, and graphically represents how the proposed digital mental health technology would affect the existing pathway.
Tips and Resources:
Guidance on the creation of a care pathway analysis, including worked examples and exercises has been created by the NIHR Newcastle In Vitro Diagnostics Co-operative.
Typical patient journeys in the NHS should in theory reflect NICE clinical practice guidelines, but practically may not. It is therefore necessary to collaborate with NHS Trusts relevant to the proposed digital therapy to establish actual rather than ideal patient journeys.
Outputs should be captured in writing, ideally using the NICE Single Technology Appraisal (STA) template which has supporting documents, including a user guide.This will save time and effort in the later Evaluation and Guidance phase of the MedTech pathway. Relevant starting sections are 1.3-1.4 and 2.1-2.2.
An example of a successfully completed NICE STA resulting in NICE recommendation for NHS adoption [MTG70] of a digital therapy addressing insomnia in adults using a self-help sleep improvement programme based on cognitive behavioural therapy can be accessed in Section 5a (Company evidence submission [Part 1 clinical]) of the supporting documentation.
More information on our PPIE section.
