Evidence, reimbursement and routes to market in digital health
Optimising reimbursement models for digital health solutions is critical for improving the quality of products on the market and boosting adoption of the most impactful solutions.
Good reimbursement models bring the best digital innovations to patients more efficiently
Optimising reimbursement for digital health solutions is a critical step in the process of digitising healthcare systems, achieving widespread scale and adoption and therefore realising the benefits promised for patients. Robust reimbursement pathways for digital solutions are necessary for two main reasons. Firstly, in their absence, the spread and scale of available digital health technologies is severely restricted, and consequently their positive impact, ultimately for patients, is limited. Secondly, without the commercial incentives offered by reliable, established routes to market, further innovation is stifled in the industry. Additionally, reimbursement needs to be more closely aligned with robust evidence standards, which should be communicated clearly to manufacturers of digital solutions. This can incentivise high-quality evidence generation and raise standards in digital health across the board.
A white paper published in March 2023 by Prova Health and Roche Information Solutions outlined the importance of establishing clear routes to reimbursement for digital solutions, and examined efforts to optimise this process in several key countries. In this piece, we review the state of play in these key markets and discuss some recent developments in this area.
Germany: continuing to improve on the DiGA process
Germany’s Fast Track pathway for digital health apps (DiGA) has received a lot of attention as the first model of its kind to deliver a national directory of digital apps approved for prescription by clinicians and reimbursement by statutory health insurers. The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) passed in 2019 paved the way for approved apps available on prescription for 73 million people covered by statutory health insurance. The Fast Track process allows high-quality digital solutions to efficiently realise adoption at national scale, something that is still not possible in many other markets.
The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) assesses all apps that apply to be listed on the DiGA directory. To date, only regulated class I and IIa medical devices (under EU MDR) are eligible for consideration. To be approved, all products must meet prerequisite standards in several domains including quality, security, data protection and interoperability. To be listed permanently on the directory, manufacturers must present data that demonstrate “positive care effects” delivered by the device, which may be actual medical benefits or procedural improvements (e.g., improved efficiency of processes).¹
For devices that meet minimum prerequisite standards, but for which manufacturers cannot clearly demonstrate positive care effects (i.e., clinical data from trials), BfArM can permit preliminary inclusion on the national register for a limited period of time. During this period the solution is prescribable for patients, and manufacturers must generate real-world evidence (RWE) demonstrating positive care effects in order to secure full admission to the register. As of July 2023, there are 18 permanently registered apps on the DiGA register, and a further 29 with preliminary registration.²
Aside from the Fast Track process, other routes to reimbursement for digital solutions in Germany include:
Individual contracts with statutory health insurers (sickness funds), providing regional market access.
Individual contracts with private health insurers.
Selling directly to consumers (DTC)
France: following in the footsteps of its neighbour
In France, the Prise en Charge Anticipée (PEC-AN) programme provides a similar rapid route to time-limited reimbursement for digital therapeutics, as well as certain remote patient monitoring (RPM) solutions not covered by other legislation. This allows temporary reimbursement (at a fixed price) by statutory insurers for one year, giving patients access to digital solutions before permanent listing has been achieved. Manufacturers of digital therapeutics must submit a request for permanent approval within 6 months from the date of temporary inclusion (9 months for RPM solutions). In contrast with Germany’s Fast Track, PE-CAN provides reimbursement for registered medical devices in all risk classes (I–III) outlined by EU MDR.
Aside from the PEC-AN pathway, the typical route to market in France for software as a medical device (SaMD), including digital therapeutics, is the same as for all medical devices: the country’s statutory health insurance system provides universal coverage for citizens. Haute Autorité de Santé (HAS) maintains a list of products and services approved for reimbursement by statutory insurance. The Medical Device and Health Technology Evaluation Committee (CNEDiMTS) evaluates CE marked devices and recommends which should be approved for reimbursement. This usually involves analysis of clinical benefit and overall value compared to available solutions. This recommendation is then considered by HAS in its final decision.
United Kingdom: still no path to national scale
In England, the main route to adoption and reimbursement for digital health solutions is through decision-makers in integrated care systems (ICSs), which are regional National Health Service (NHS) bodies responsible for procurement and delivery of health services at a local level. Products, including digital solutions, are not reimbursed until individual ICSs grant access in their region. There are no mandatory evaluation pathways that guarantee approval and reimbursement, and digital solutions are not widely available on prescription as in Germany.
The NICE evidence standards framework (ESF) for digital health technologies (DHTs) provides guidance to both industry and NHS decision-makers on what evidence should be produced prior to procuring a digital solution. NICE also makes recommendations about the value of specific solutions, however this approval is not directly linked to reimbursement opportunities. The current disconnect between NICE guidance and reimbursement means there is limited incentive for manufacturers to follow guidelines about evidence generation.
United States: private plans leading the way
In the US, digital health innovators can take many different routes to access the market. However, evidence requirements are not standardised, with each payor setting their own. Evidence demonstrating clinical benefit and the economic value delivered by digital solutions will be required as a minimum for reimbursement in most cases, along with the prerequisite FDA approval for regulated medical devices.
Many mechanisms for reimbursement are based on a fee-for-service model, and therefore tied to time- and effort-based metrics that are not well-suited to some digital solutions. Within this type of system, digital solutions that improve the efficiency of clinical processes could struggle to find reimbursement.
The Centers for Medicare and Medicaid Services (CMS) operate the two largest publicly funded healthcare programmes in the US. While CMS has established policy on the reimbursement of certain digital solutions (mainly RPM solutions and telemedicine services), there is no cohesive policy guiding the reimbursement of most other digital health solutions. Models designed to work for hardware and drugs are often not a good fit for software solutions, and this has limited the widespread adoption of such products in these large publicly funded systems. On the other hand, many private insurers have developed their own frameworks for the assessment of digital solutions, and have made more progress in delivering these to patients. Having taken the lead in this area, private insurers are well placed to set strong evidence standards in digital health, incentivising robust evidence generation by manufacturers and ultimately increasing the quality of solutions reaching patients and clinicians.
Our discussions with leading global experts have revealed a consensus that reimbursement in every major market needs to align more closely with robust, well-defined evidence standards.³ Global policymakers should strive to create reliable, efficient routes to national-scale reimbursement for digital solutions. Decision-making processes must be clear to innovators, and should allow for the sensible use of RWE. These conditions must be met for high-quality digital solutions to be adopted at large scale, and to realise the positive impact they promise for patients everywhere.
Prova Health supports digital health innovators with evidence generation. To discuss how we can help with evidence generation for your digital solutions, email email@example.com
Dr Des Conroy is a Digital Health Consultant at Prova Health. As a medical doctor, he has worked in clinical practice in the UK and Ireland. He has experience developing and clinically validating artificial intelligence-based Software as a Medical Device (SaMD) products, and supporting their deployment at a global scale. At Prova Health, he has led research into evolving evidence standards and reimbursement models in digital health.
Dr Saira Ghafur is Co-founder and Chief Medical Officer of Prova Health. She is an honorary consultant Respiratory Physician at St Mary’s Hospital, London, and a digital health expert who has published on topics such as cybersecurity, digital health adoption and reimbursement, data privacy and commercialising health data. She is Co-founder of mental health start-up Psyma and holds a MSc in Health Policy from Imperial. She was a Harkness Fellow in Health Policy and Practice in New York (2017).
1. BfArM (no date), DiGA. Bfarm.de. Available at: https://www.bfarm.de/EN/Medical-devices/Tasks/DiGA-and-DiPA/Digital-Health-Applications/_node.html (Accessed: 5 July 2023)
2. Flying Health (2023), DiGA Watchlist July 2023. https://www.flyinghealth.com/ (Accessed: 5 July 2023)
3. Conroy, D., Fontana, G., Prime, M. and Ghafur, S., 2023. Generating evidence for digital health solutions. Available at: https://healthcaretransformers.com/digital-health/current-trends/generating-evidence-for-digital-health-solutions (Accessed: 5 July 2023).