What does it take to secure access to digital health apps in the UK?

Article originally published 11th August 2022, updated 18th June 2024.

Introduction

Digital health apps are designed to improve personalised care and population health with the support of mobile devices. They offer a large array of functionalities, from health monitoring and virtual contact with healthcare providers to personalised guides on improving wellness. The recent technological advancements and the magnified by the COVID-19 pandemic need for virtual solutions have contributed to the proliferation of these digital tools: with more than 90,000 digital health apps being released to app stores just in 2020, over 35,000 of them are now available to customers.^[1]

The rapid emergence of apps and other digital health technologies (DHTs) presents both opportunities and challenges to health systems seeking to provide innovative and cost-saving patient care. A variety of digital products have been already incorporated into healthcare guidelines and their impact on the landscape of patient care is growing.

The lack of a standardised framework for the inclusion of DHTs into the statutory health insurance system led to countries evolving different approaches, with many regulatory and reimbursement pathways still transforming to best accommodate the unique nature of those products.^[2]. (Read our ISPOR research here for more details on this).

In the UK, there is a framework for the assessment of digital health technologies in place, however, streamlined, robust and direct access to statutory reimbursement is missing. Instead, pricing and reimbursement decisions are made at a local level.

Regulatory approval is the first step in the pricing and reimbursement process for DHTs in the UK 

Digital health products (including apps, software and wearables) that meet the definition of a  medical device, must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed on the UK market.[4]  They must be UKCA marked in line with the Medical Device Regulations (UK MDR 2002[5]) in order to ensure they are regulated and acceptably safe to use and also perform in the way the manufacturer/developer intends them to. Following the UK’s exit from the European Union (EU), the equivalent CE certification and approvals completed by the EU are recognised until 2030 (an extension from the previous 2023 deadline).

NHS provides guidance on the evidence needed for clinical and economic assessment

The National Health Service (NHS), The National Institute for Health and Care Excellence (NICE) and the UK Health Security Agency have published resources to support both the DHTs developers and the decision-makers during the commissioning and reimbursement decisions.[6]

NICE has developed the Evidence Standards Framework (ESF), which is specific to the DHTs that are considered for commissioning in the UK health and care system. It aims to provide guidance on the evidence requirements to assess both the clinical and economic impact of the product and early deployment standards aimed to guide the evidence generation programmes.

ESF is complemented by the Digital Technology Assessment Criteria (DTAC) which was launched in 2021 by the NHSX (a joint unit of NHS England and the Department of Health and Social Care, supporting local NHS and care organisations to digitise their services). DTAC is a tool providing baseline criteria for DHTs used in the NHS and social care. It covers five core areas: clinical safety, data protection, technical security, interoperability, and separate conformity rating of usability and accessibility.

Evidence standards framework for digital health technologies

The DHTs are classified based on their function and grouped into three evidence tiers designed to capture the level of clinical risk presented. ESF lists the minimum evidence standards and best practice standards in each tier, outlining the incremental level of evidence required with each subsequent tier:

• Tier A: system services. It includes the DHTs which provide services to the health and social care system and do not produce measurable patient outcomes.
• Tier B: includes DHTs that help patients to manage their own health and wellness by means of communicating and promoting health and care and offering health and care diaries.
• Tier C: Includes DHTs for treating and diagnosing medical conditions or guiding care choices. Those DHTs will have direct health outcomes and are likely to be regulated as medical devices.

NICE assesses selected digital health apps

Differently to medicines, NICE recommendation is not necessary for NHS to fund digital health apps. However, NICE can decide to assess selected DHTs and provide unbinding recommendations to NHS commissioners through two different routes: Early value assessment (EVA)[7] or Medical Technology Evaluation Programme (MTEP).[8]

• Early value assessment EVA
• Launched in 2023, EVA aims to identify the most innovative technologies in health and social care that address the highest priority needs, expedite provisional recommendations, and support ongoing evidence collection. Digital technologies are filtered and selected by NICE if they:
• Have the potential for patient and system benefit in an area of national unmet need
• Are supported by HCPs and the healthcare system
• Need further evidence generation before they can be recommended for use in the NHS.

EVAs provide the NHS with guidance about the value of a technology, including a recommendation for use while evidence is generated. Unlike full NICE guidance, technologies selected for EVA are not expected to have a complete evidence base before they’re recommended for use.

• Medical Technology Evaluation Programme MTEP
• The MTEP evaluates mature technologies that could provide benefits to patients and the health and social care system compared to current practices, with the aim of increasing their adoption within the NHS.
• Technologies for assessment are selected by NICE out of products registered with NHS Innovation Service if they:
• offer substantial benefits to patients or the health and care system compared with current practice
• the benefits are plausible, clearly described, easily understood and supported by evidence
• developing guidance would mean faster and more consistent adoption of the technology

Unlike EVA, the evidence-based requirements in the MTEP program are very stringent. So far, only one digital health application, an app helping to fight insomnia called Sleepio, gained positive recommendation through this route.[9]

Final reimbursement decisions are made at a local level

The reimbursement of digital therapeutics in the UK is decentralised. After receiving the appropriate regulatory approval (CE or UKCA mark), a product can be evaluated at a local level by integrated care systems, ICSs,[10] who make the decision on reimbursement based on their own clinical budget. A positive assessment from NICE (through EVA or MTEP) may accelerate and boost uptake; however, the recommendations are not binding, and the final decision on adoption is left to local commissioning bodies.

Local commissioners typically prioritise the economic impact and saving opportunities during their assessment.¹ The evidence requirements may vary between the commissioners, but they frequently require real-world evidence (RWE) on the impact of assessed DHTs on their population. DHTs providers use the data collected in pilot programs in their submission dossiers to other commissioning bodies, however, the lack of a centralised reimbursement model remains a major impediment to the wide adaptation of health apps.

Conclusion

The digital therapeutics landscape has immensely expanded in recent years, and it can be anticipated that digital health apps will be included in healthcare guidelines more frequently. However, the pathway to reimbursement for DHTs remains complex and challenging. Before developers can seek reimbursement for their digital health product, they must obtain regulatory approval in the form of CE or UKCA mark. NHS and NICE guide the evidence needed to prove effectiveness and outline the economic impact to commissioners. The final reimbursement decisions are made at a local level with saving opportunities usually being a top priority for local healthcare authorities.

Sources:

1. IQVIA, 2021. Digital Health Trends 2021. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/digital-health-trends-2021 [accessed 14/06/2024]
2. The Hope Programme® 2023. DEVELOPING AND TESTING DIGITAL HEALTH APPS: HIGH EFFORT, HIGH COST? https://www.h4c.org.uk/blog/stroke [accessed 14/06/2024]
3. Gordon, W.J., Landman, A., Zhang, H. et al. Beyond validation: getting health apps into clinical practice. npj Digit. Med. 3, 14 (2020). https://doi.org/10.1038/s41746-019-0212-z [accessed 14/06/2024]
4. GOV UK Guidance. Last updated July 2023. Medical devices: software applications (apps) https://www.gov.uk/government/publications/medical-devices-software-applications-apps [accessed 14/06/2024]
5. The Medical Devices Regulations 2002, https://www.legislation.gov.uk/uksi/2002/618/contents/made [accessed 14/06/2024]
6. Evaluating digital health products. https://www.gov.uk/government/collections/evaluating-digital-health-products [accessed 14/06/2024]
7. NICE Early Value Assessment https://www.nice.org.uk/about/what-we-do/eva-for-medtech
8. NICE Medical Technologies Evaluation Programme https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-medical-technologies-evaluation-programme [accessed 14/06/2024]
9. NICE. Sleepio to treat insomnia and insomnia symptoms. https://www.nice.org.uk/guidance/mtg70. [accessed 14/06/2024]
10. Integrated care in your area. https://www.england.nhs.uk/integratedcare/integrated-care-in-your-area/ [accessed 14/06/2024]