A paradigm shift in how healthcare is received and delivered is currently underway, with digital health solutions, including digital health applications (DHAs), developing at a high pace and carrying the potential to disrupt the way we diagnose, treat and manage diseases. However, while the digital health applications landscape is rapidly evolving, the regulatory and health technology assessment (HTA) environment is evolving more slowly, struggling to keep that pace.
Existing access pathways and frameworks, designed for pharmaceutical products and medical devices, are being found to be inadequate to accommodate the peculiar nature of digital health solutions. As a result, HTA bodies are having to review their pricing and reimbursement pathways to determine what represents “good evidence” in the context of digital health applications. However, these developments are occurring at different speeds across markets, resulting in a highly fragmented and evolving digital health applications pricing and market access landscape that can be difficult for manufacturers to navigate.
What are digital health applications?
Different from general health and wellness applications, which focus on promoting overall health and life-style improvements, digital health applications are developed to fulfil a medical purpose, targeting a specific health condition. They are software-based medical interventions designed to support prevention, diagnosis, treatment, and management of diseases and disorders1. As such, they are subject to specific standard of evidence and regulatory oversight: they need to be CE-marked as are medical devices and demonstrate clinical benefit in order to be reimbursed and prescribed1,2. Looking at the digital health application landscape, there is currently a focus on developing applications in areas such as:
- Mental health disorders (including substance and sleep disorders)
- Chronic diseases, such as diabetes, cardiovascular disease, respiratory diseases.
While both pharmaceutical products and DHAs need to demonstrate clinical and economic value, there are additional evaluation criteria that only apply to digital health applications and that are entirely new to payers. These include data security, privacy, interoperability, scalability and usability3,4,5,6. In addition to this, many digital health applications can be associated with benefits which are not typically seen with pharmaceutical products, resulting in challenges in how these are evaluated.
For example, many DHAs provide benefits such as improved patient health literacy, increased patient engagement in health management, quicker and expanded access to care, less burden on health care professionals1,7. These benefits may translate to cost savings to the health care system, however, are not easily captured. Because of this, there is an important need for payers to have clinical and economic evaluation criteria that can adequately capture all benefits of digital health applications and provide a clear insight into the value of the technology.
Market Access landscape for digital health applications in the UK and EU4
The proliferation of DHAs combined with the awareness of their value for patients outcomes and healthcare systems, has prompted regulatory and HTA authorities to rethink their evaluation and reimbursement frameworks in order to incorporate digital health applications in a way that accounts for their distinct characteristics. Over the past few years, a number of initiatives have been taken in this direction. Looking at the EU4 and UK in particular, some countries have began to design specific evaluation frameworks and establish centralised reimbursement processes for DHAs (see Table 1). However, other countries (such as Spain and Italy) are lagging behind with no dedicated evaluation framework and with reimbursement and funding decisions taken at the local level.
|Decentralised and centralised
ANS and CNEDiMTS
Ministry of Health and Social Security
Notably, Germany is leading the way with a well-established centralised digital health applications-specific reimbursement process. Since 2020, a fast-track process for digital health applications (referred to as the DiGA fast-track) has been established3. The centralised process allows rapid evaluation by the federal Institute for Drugs and Medical devices, BfArM, for eligible technologies (Class I or IIa medical devices used either by patients alone or by patients and HCPs, for the recognition, monitoring, treatment and management of disease, injuries and disabilities). If a DHA is successfully listed in the DiGA directory, it will be 100% reimbursed by the Statutory Health Insurance at the price set by the manufacturer for the first 12 months, and at the price negotiated with the National Association of Statutory Health Insurances (GKV-SV) afterwards.
This fast-track process is designed to take a maximum 3 months and there are two possible positive outcomes:
- Permanent listing in the DiGA directory for the digital health applications that meet all the general requirements and have sufficient clinical evidence
- Preliminary/provisional listing in the DiGA directory for digital health applications that meet all the general requirements but lack sufficient evidence. In this case, the developer has 12 months to submit clinical evidence in order for the digital health application to be permanently listed. If the evidence are not considered sufficient, then the digital health application will be removed from the from DiGA directory and will be no longer reimbursed.
Currently, in Germany, 47 digital health applications are reimbursed across 20 disease areas. Of these 18 are permanently listed and 29 are provisionally listed in the DiGA directory7.
In March 2023, following the German example, France introduced a fast-track reimbursement route for digital health solutions, including digital health applications, the Prise en Charge Anticipée (PEC-AN) scheme4,8. Digital medical devices that are presumed to be innovative can be reimbursed for one year while additional evidence is being gathered/ collected and the standard and permanent reimbursement request is being finalized. The fast-track route involves a 60 days parallel assessment. The French Digital Health Agency, Agence du Numérique en Santé (ANS) is responsible for ensuring compliance with interoperability and security standards. In addition, the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS), within Haute Autorité de Santé (HAS), is responsible for deciding on the presumption of innovation of the digital health applications. Based on the outcomes of these assessments, the ministers of health and social security make the final coverage decision within 30 days. It is important to note that while the French PEC-AN route explicitly follows the example of the German DIGAs fast-track, which digital health solutions are considered eligible for the centralized reimbursement route differ between the two countries. Unlike Germany, where only digital medical devices class I and IIa are eligible for the DIGAs fast-track, in France medical devices class IIb and III and those used for telemonitoring are evaluated through the PECAN scheme3,4.
In the UK, both the Digital Technology Assessment Criteria (DTAC)5 and the NICE Evidence Standards Framework (ESF) for digital health technologies (DHTs)6,9 provide a standardised set of criteria for assessing products such as digital health applications.
The DTCA covers five core areas:
- Clinical safety
- Data protection
- Technical security
- Usability and accessibility
The EFS, which groups digital health applications into tiers based on their function and associate risk, defines the level of evidence required to demonstrate their effectiveness and economic value.
NICE states that it can conduct evaluations of digital health technologies through each of its 4 guidance programmes10:
- Technology appraisals
- Highly specialised technology appraisals
- Medical technology evaluations
- Diagnostic appraisals.
The programme used will depend on the technology and its expected impact on the health and social care spend. In practice, digital health technologies are predominately appraised through the medical technology evaluation or diagnostic appraisals programmes. NICE guidance through either of these programmes are not associated with a funding mandate and so whilst recommendations on the digital health application can be given, local stakeholders will ultimately make the decision to implement usage. (For more information on this see our previous article “What does it take to secure access to digital health apps in the UK?”11)
In addition, like Germany and France, NICE in England has recognised a need for fast appraisals for products such as digital health applications and is currently piloting an early value assessment (EVA) programme for products that meet a national unmet need12. For digital technologies to be considered for EVA pilot, they must have prior DTAC approval however, given the purpose is to speed up access to them, they are not expected to have a complete evidence base at the time of EVA. Indeed, following a recommendation for early use in the NHS, NICE will provide an evidence generation plan, detailing what evidence are expected to be gathered while the technology is in used. Once these real-world evidence are presented, NICE will be able to make a full and final recommendation.
It should be noted that NICE has only recently began to review digital health applications and only DHTs that fall under the tier 3 of the ESF and are deemed to be a step change will be considered for appraisal. Because of this, in England, many digital health applications are not currently centrally appraised by NICE and instead must be evaluated at a local level in order to gain access.
In Italy and Spain there are no specific evaluation frameworks and national pricing and reimbursements routes and digital health applications are considered as medical devices which, in both countries are evaluated, reimbursed, and funded at a regional/local level. However, in Spain, the regional health authorities of Andalusia and Catalonia, has developed an assessment framework and a certification system, respectively, for mobile health applications. In Catalonia, the Agency for Health Quality and Assessment of Catalonia (AQuAS) is developing the dedicated assessment framework following the NICE EFS example. In Italy, some regions are paying for tele visits as they do for face-to-face visits13. (For more information on the cross-country variation in the access routes for digital health applications, see our ISPOR US 2023 poster “How do the reimbursement opportunities for digital health applications vary across the US, Europe and Japan?”14)
Enabling quick and dedicated assessments for digital health applications is a clear trend that is emerging across countries, however not all countries are doing this at the same speed and in the same way. As a result, manufacturers are facing a significantly fragmented landscape that requires a country-specific and, hence, resource-intensive approach. Regulatory and reimbursement legislations and frameworks are still in an experimental phase and will continue to evolve. Manufacturers should closely monitor and try to anticipate any changes to develop successful evidence generation plan and go to market strategies for their products.
Looking for more reading material on digital health applications? Why not read our research for this year’s ISPOR Annual: ISPOR US 2023: Digital Health Applications – Remap Consulting