Introduction
Digital health applications (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 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 30,000 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]
In the UK, there is a framework for the assessment of digital health technologies in place, however, a 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) which are classified as medical devices are regulated under the Medical Devices Regulations 2002[3] and must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed on the UK market.
The regulatory processes underpinning the approval of DHTs will undergo changes in the UK following its departure from the EU.[4] The European Conformity (CE) mark as a sign of regulatory approval will be recognised until 30 June 2023. Before the implementation of the new EU Medical Device Regulation (MDR 2017/745) [5] in May 2021, most DHTs could undergo a self-assessment procedure to obtain a “CE” mark classification. However, under the updated regulation, clinical data reviewing safety, effectiveness, and performance is needed for most DHTs.
On the 26th of June 2022, MHRA published the UK government’s response to the consultations on the regulatory framework for medical devices.[6] The new plans aim to strengthen the regulation of medical devices to improve patient safety and encourage innovation in the post-Brexit UK. Some of the key changes will include more stringent pre- and post-market requirements for clinical evaluations and performance studies, and replacement of the CE mark with the UK Conformity Assessed (UKCA) mark as a certification stamp, which will be obligatory after June 2023.
The digital health apps that meet the technical and clinical safety standards, can be further assessed by clinical policy teams within National Health Service (NHS) England and NHS Improvement. Prior to December 2021, they were listed in the NHS Apps Library, which had been decommissioned since.[7] Currently, NHS recommended apps that met the required technical and clinical safety standards and were approved by experts in a relevant area (such as mental health policy or children’s health policy) are linked throughout the NHS website.
NHS provides guidance on the evidence needed for clinical and economic assessment
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.[i]
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. Published in 2018, it aims to provide guidance on the evidence requirements to assess both the clinical and economic impact of the product. The most recent update of the ESF (9th August 2022) has aligned the guidelines with the regulatory requirements and introduced evidence requirements for artificial intelligence. It also now features early deployment standards aimed to guide the evidence generation programmes.
ESF is complemented by the Digital Technology Assessment Criteria (DTAC) which was launched in the spring of 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, which replaces NHS Digital’s digital assessment questionnaire (DAQ), is a tool providing baseline criteria for DHTs assessment. 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.
The standards assigned to each tier are presented in groups related to phases of the DHT product life cycle. There are 21 standards arranged in 5 groups:
- Design factors: The 9 standards identify key aspects of the design process that impact the DHT’s value to the health and care system, including ensuring the technology has the appropriate technical standards for safety and reliability.
- Describing value: The 4 standards apply across all tiers and provide information to build the value proposition of the DHT. The mandatory ones include description of the intended purpose, target population, and expected health, cost and resource impacts of the proposed pathway or system process incorporating DHT compared to the current one.
- Demonstrating performance: The subsequent standards are designed to help ensure that the DHT meets its performance expectations. Products in all tiers should provide real-world evidence that the claimed benefit can be realised in practice and agree on a plan for measuring usage and changes in the DHT’s performance over time. Additionally, Tier C DHTs need to provide evidence of the DHT’s effectiveness to support their claimed benefit.
- Delivering value: All DHTs should demonstrate their value for money by providing a budget impact analysis, For DHTs with higher financial risk, cost-effectiveness analysis should also be provided.
- Deployment considerations: Those standards help to ensure that the claimed benefits of the DHT can be realised in practice by ensuring the appropriate scalability and transparency about requirements for deployment. Companies should also prepare strategies enabling the end users to understand the assessed DHT.
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, (formally by Clinical Commissioning Groups (CCGs)[12] and from 1st July 2022 by integrated care systems, ICSs)[13] who make the decision on reimbursement based on their own clinical budget.
Local commissioning bodies 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.
A change in the reimbursement processes for DHTs might be on the way. NICE has recently demonstrated the ambition to encompass DHTs assessments. on 20 May 2022, NICE published its first guidance on a digital therapeutic – an app helping to fight insomnia called Sleepio.[14] The first national appraisal might pave the way for new standards for assessing the DHTs and deciding on their reimbursement, leading to more robust access to NHS funding for digital 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 provide guidance on 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.
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The Medical Devices Regulations 2002, https://www.legislation.gov.uk/uksi/2002/618/contents/made [accessed 20/07/2022]
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Section B: Value proposition — non-assessed section. Accessed Mar 2021. https://www.nhsx.nhs.uk/key-tools-and-info/ digital-technology-assessment-criteria-dtac/value-proposition-non-assessed-section/ [accessed 20/07/2022]
Allocations for 2019/20 to 2023/24. https://www.england.nhs.uk/allocations/previous/allocations-for-2019-20-to-2023-24/ [accessed 20/07/2022]
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