November 7, 2024

Advancing Digital Excellence

Pioneering Technological Innovation

“Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning”

“Towards harmonizing assessment and reimbursement of digital medical devices in the EU through mutual learning”

The analysis of assessment frameworks for DMDs across EU Member States reveals the existence of five distinct clusters (Fig. 1). The first grouping includes Germany, Belgium and France, three EU countries with national statutory frameworks for DMDs that integrate both regulatory and reimbursement pathways. Germany was the first country to combine regulation and reimbursement for digital health applications (“Digitale Gesundheitsanwendungen”, DiGA), with its 2019 Digital Health Care Act (“Digitale-Versorgung-Gesetz”, DVG)13 and the Digital Health Applications Ordinance (“Digitale Gesundheitsanwendungen-Verordnung”, DiGAV) which came into force in April 2020 outlying the specifications for the assessment of DiGA14. According to the related procedure, DiGAs can be prescribed by physicians and psychotherapists, or alternatively requested by insured individuals with proof of the corresponding indication. Approved DiGAs are listed in the national directory and reimbursed by all health insurers as per statutory regulations. A new Digital Health Act (“Digital-Gesetz”, DigiG) to further accelerate the digitalization of the healthcare system was approved by both houses of the German Parliament and came into effect on March 26, 202415. This legislation includes significant provisions for the expansion of the DiGA framework, primarily aimed at better integrating DiGAs into healthcare processes and enabling more complex treatments. Furthermore, in 2021 German authorities defined a reimbursement scheme also for digital nursing applications (DiPA) targeting individuals in need of care16. Although DiPAs do not meet the DMD definition, a similar framework to that for DiGAs exists, with some differences, such as the lack of a provision for temporary reimbursement and the absence of prescription mechanisms for DiPA. Due to these reasons, the program has been generally less attractive, resulting in no approved applications to date.

Fig. 1: Mapping of assessment approaches for DMDs by EU Member States.
figure 1

Classification of EU Member States’ approaches to DMD assessment into five clusters based on the status of the frameworks (active, under development, or missing) and their primary purposes, including coverage and reimbursement, value assessment, orientation of individual choices and behaviors and taxonomy definition.

In 2015, public health authorities in Belgium agreed to develop a framework for the integration of DMDs in the healthcare system. In 2018, as a result of collaboration between public institutions and the industry, quality and reimbursement requirements were established, and the mHealth validation pyramid was introduced, consisting of three different certification levels17. The specific evaluation process and the reimbursement module associated with level 3 of the pyramid were launched in January 2021. Under this process, manufacturers were required to notify their application to the National Institute for Health and Disability Insurance (NIHDI), which used to activate an ad-hoc working group to assess the mobile app. Upon receiving a positive recommendation, the healthcare insurance committee of the NIHDI, as the decision-making body, would make the final decision on integration and reimbursement. Due to the significant implementation challenges of the original procedure17, a new reimbursement process was approved in July 2023 to revitalize the framework, including substantial incremental enhancements, such as the establishment of a permanent multidisciplinary working group and the formal inclusion of temporary reimbursement.

France, for its part, offers multiple pathways for the reimbursement of DMDs. Therapeutic software can gain access through the standard MD pathway upon registration in the list of products and services qualifying for reimbursement (“Liste des Produits et Prestations Remboursable”, LPP), while telemonitoring DMDs can be registered in the recently established list of remote medical monitoring activities (“Liste des Activités de Télésurveillance Médicale”, LATM). The LATM was introduced after the conclusion of the ETAPES program, a temporary national funding initiative for remote patient monitoring experimentally launched in 201618. Furthermore, since March 2023, the “Prise en charge anticipée numérique” (PECAN) provides a one-year early coverage for DMDs with purportedly innovative features that are yet to demonstrate their expected clinical or organizational benefits19. As outlined in Table 1, these frameworks reveal both cross-national similarities and differences in their approaches.

Table 1 In-depth comparison of reimbursement frameworks for DMDs in EU pioneering countries

All frameworks start with the submission of an application by a manufacturer (or possibly by hospitals, professional organizations, or scientific associations in the case of Belgium), followed by an initial eligibility evaluation. In terms of targeted technologies, all models establish explicit links with the EU MDR, requiring a valid CE mark as a prerequisite for eligibility. However, partial differences in risk levels and functionalities exist among the programs concerning the DMDs of interest. The DiGA model originally included only patient-centered DMDs of risk class I or IIa (as per the EU MDR) whose main function is based on a digital technology. However, with the introduction of the new DigiG15, the definition of DiGA has been broadened to also encompass risk class IIb DMDs. This expansion has paved the way for the offering of additional applications, such as telemonitoring tools. These new applications must conform with the DiGA definition, ensuring they function as digital assistants that empower individuals and provide them with individualized feedback based on the collected data. The Belgian mHealth framework also covers software applications designed for use by patients throughout their healthcare journey, including those with remote monitoring, therapeutic, or diagnostic functions, provided they facilitate the sharing of health-related information with healthcare professionals, without explicit limitations in terms of risk class. Instead, France encompasses DMDs of all risk classes with therapeutic or telemonitoring functions. Therapeutic DMDs are typically patient-centered, while telemonitoring involves a patient using a DMD with remote medical monitoring by a medical professional or a team. Applications for primary prevention are not eligible for statutory reimbursement under any of the considered legal frameworks.

After the submission phase, a comprehensive assessment process ensues. While all three frameworks adopt a centralized approach to DMD assessment, their governance structures differ in terms of institutional arrangements and responsibilities. In Germany, the evaluation and certification processes are exclusively conducted by the Federal Institute for Drugs and Medical Devices (“Bundesinstitut für Arzneimittel und Medizinprodukte”, BfArM). In Belgium, the NIHDI serves as the competent authority for value assessment and is now supported by a permanent, external multidisciplinary group including members with a composite background. In contrast, in France, the PECAN evaluation process is streamlined through parallel assessments by two entities: the CNEDiMTS (“Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé”), which is the committee of the National Authority of Health (“Haute Autorité de Santé”, HAS) responsible for evaluating DMDs for potential clinical benefits and organizational improvements, and the Digital Health Agency (“Agence du Numérique en Santé”, ANS), under the auspices of the Ministry of Health and Prevention, tasked with verifying compliance with interoperability and security requirements. Following the opinions of CNEDiMTS, an order by the Ministers of Health and Social Security confirms eligibility for early reimbursement.

All jurisdictions offer the possibility of early coverage with largely consistent goals, via fast-track procedures intended to facilitate coverage for promising DMDs while the evidence base is still in the process of development. However, the mechanisms of action vary to some extent. In the German fast-track process, DiGAs of risk class I and IIa can receive provisional listing for 12 months based on an early indication of positive care effect, with the possibility for manufacturers to request an extension for up to an additional 12 months. Manufacturers are required to submit a scientific evaluation concept, prepared by an independent scientific institution, certifying the likely contribution to improvements of care. Provisional listing in the DiGA directory is not available for DiGAs of risk class IIb. Similarly, PECAN, the French early coverage pathway, offers temporary, non-renewable reimbursement for expectedly innovative DMDs, based on the preliminary analysis of available data. Following the reimbursement decision under PECAN, manufacturers of DMDs with therapeutic purposes and remote monitoring solutions have respectively up to 6 and 9 months to submit their applications for reimbursement under general law. After the approval of the new procedure, also the Belgian framework formally includes an early access pathway. While temporary reimbursement was possible but not actively promoted in the past, it is now available for applications with incomplete evidence and those requiring a global revision of the care process for which a temporary solution is possible in the interim. In such cases, temporary reimbursement is contingent upon the availability of preliminary evidence, an ongoing study (not necessarily randomized) aimed at removing uncertainties, and endorsement from a professional organization or scientific association. The temporary reimbursement within the Belgian framework is projected to last for a standard duration of three years, with interim reports required after 18 months and the final reimbursement request dossier to be submitted within 6 months of the expiry date.

The three assessment frameworks all center their decision on proof of effectiveness of the DMDs, albeit with partially different provisions. The DiGA model is focused on evidence of the so-called positive care effects (“positive Versorgungseffekte”, pVE). These pVE can manifest as either a direct medical benefit or a patient-relevant improvement of structure and processes (referred to as “patientenrelevante Struktur- und Verfahrensverbesserungen”, pSVV). Section 8(3) of the DiGAV incorporates a list of nine different constructs for pSVV, including aspects such as health literacy, coordination of treatment procedures, and enhanced access to care14. For the approval of DMDs in risk class IIb, a medical benefit must always be demonstrated, with the possibility of additionally including pSVV. The focus of evaluation within the Belgian framework is instead directed towards the clinical or socio-economic added value that the mobile application can provide within the context of a specific care pathway. In France’s PECAN, DMDs must incorporate innovative features that offer clinical and/or organizational benefits. Subsequent inclusion in the standard reimbursement lists involves additional considerations. To register therapeutic DMDs in the LPP, the CNEDiMTS evaluates the actual clinical benefit, both at the individual level and in terms of broader impacts on the overall organization of care. The evaluation also assesses the clinical added value (CAV) against a relevant comparable product, procedure or service. Telemonitoring applications can instead be registered on the reimbursement list under a generic name, for DMDs with comparable technical specifications to other products, or a brand name, if the technical specifications do not correspond to any existing generic lines. For the incorporation in the generic list, the DMD manufacturer has to demonstrate eligibility by obtaining the certificate of compliance issued by ANS. On the other hand, registration under the brand list requires a dedicated evaluation by the CNEDiMTS, with expected benefits in terms of either clinical improvement, significant gains in the organization of care, or public health interest.

The assessment models are generally non-restrictive as to the methods for producing the above-mentioned evidence, accepting a broad range of research methodologies and study designs. The only essential requirement is a comparative approach to substantiate the claimed benefits. The German DiGA Fast-Track offers flexibility in the choice of study design, requiring, at a minimum, that a quantitative comparative study is performed. While retrospective comparisons are possible, prospective studies are generally preferred. It is reasonable to assume that expectations towards study designs for DiGAs of risk class IIb will be higher. The DiGA guide, an official document published and regularly updated by BfArM primarily to support manufacturers in applying for listing, explicitly mentions the option of adopting alternative study designs that incorporate adaptive components and real-world data sources20. In terms of study comparators, the DiGA framework currently foresees three alternatives: non-treatment, treatment with no use of DiGA, and treatment with a comparable DiGA. The selection of the suitable comparator group must be based on the standard of care for the respective indication20. Furthermore, ongoing debate surrounds a potential fourth option for study comparators—the design of placebo DiGAs21. Studies must be conducted in Germany, unless the comparability of the healthcare situation in another context can be proven. In Belgium, applicants have substantial flexibility in choosing study methodologies, with no explicit instructions regarding study designs, except that randomized controlled trials (RCTs) are not mandatory. Similarly, in France there are no stringent requirements for study designs or comparators. While multicentric RCTs are still considered as the design providing the highest level of evidence for common law reimbursement under the LPP, alternative methods are accepted by the CNEDiMTS for all MDs if a well-built RCT is not feasible, and comprehensive guidelines for the use of real-world evidence (RWE) are available22.

The assessment frameworks designed by these pioneering countries complement the evaluation of clinical benefits with additional assessment domains. In Germany, BfArM evaluates compliance with the technical requirements defined in Sections 3 to 6 of the DiGAV, focusing on safety and suitability for use (demonstrated through the formal legality of the CE marking), data protection, information security, and quality—primarily in terms of interoperability but also considering robustness, ease of use, and quality of medical content. With respect to data privacy and security, in April 2024, BfArM has announced that new standards will be implemented in the coming months, with accredited test bodies responsible for issuing the necessary certificates. Similar criteria are required in Belgium, where compliance with MDR requirements and proof of interoperability and connectivity to the national eHealth platform are prerequisites for subsequent reimbursement. In France, the ANS issues a certificate of compliance with interoperability and security standards, a necessary requirement for all reimbursement pathways. While economic considerations are not formally considered for inclusion in the DiGA directory, they can become relevant factors during later price negotiations. Instead, in Belgium, the dossier submission includes an economic file to demonstrate the socio-economic value of the DMD, encompassing considerations on the budget impact on the Belgian healthcare system and a section for cost-effectiveness analysis. However, it is not mandatory for clinical benefits and economic impact to be directly compared against each other. Economic evaluations can also be part of submissions to the HAS for general law reimbursement of therapeutic DMDs, provided that sufficient efficacy and cost data are available. The assessment of economic evidence is not conducted by the CNEDiMTS but by a dedicated commission, the Economic and Public Health Assessment Committee (“Commission d’évaluation économique et de santé publique”, CEESP). Additionally, France places considerable emphasis on organizational impact, a cornerstone in both PECAN and standard reimbursement pathways. HAS has published dedicated guidelines for all health technologies, focusing on their influence on care processes, required capabilities and skills, and societal implications23. Although not as explicitly stated, the consideration of organizational impact is also implied in the frameworks of both Germany and Belgium. As already noted, in Germany, positive care effects for lower-risk DMDs can be demonstrated also through patient-relevant improvements in the provision of care. Instead, Belgium aims to reimburse only DMDs that substantially restructure care pathways.

Value assessment primarily focuses on the preparatory stages for patient access across all jurisdictions, distinct from post-market assessments. Both the German and Belgian frameworks currently rely on a one-time assessment, meaning that once the software is permanently listed, no further evaluation is foreseen. In Germany, the sole exception is in the case of “significant changes” to a DiGA, in which case prompt notification to the BfArM by the manufacturer is required. The BfArM then decides within 3 months whether to remove the application or adjust the register to reflect the updated features. However, the DigiG has introduced a real-world application-related performance measurement. Starting from January 2026, patient-reported outcome and experience measures (PROMs and PREMs), as well as information on the usage of a DiGA, will be published in an online repository and updated on a quarterly basis, partially influencing reimbursement amounts. In contrast, in France, reimbursement after the inclusion in the standard lists is valid for up to five years, after which renewal is necessary. Furthermore, a follow-up to evaluate the real-world performance of medical devices is possible, primarily to support indication extensions or inclusion renewals24.

The outcomes of assessment processes are closely interconnected with the reimbursement of DMDs, with pricing mechanisms reflecting marked cross-country differences based on the unique traits and aims of each program. In the DiGA framework, manufacturers set their price freely (typically on a three-month subscription basis) for the first year after being listed in the directory, regardless of whether acceptance is provisional or final. These prices must, however, comply with maximum limits established by regulations. Maximum prices are set for clusters of comparable DiGAs targeting the same indication according to the three-digit ICD-10-GM disease classification and demonstrating the same type of positive care effect (medical benefit versus patient-relevant improvement of structure and processes)25. Specific pricing mechanisms apply to DiGAs considered pioneers in their indication group, those targeting rare diseases, or those based on complex artificial intelligence functions26. Beyond the initial 12 months, the final price is determined through negotiations between the manufacturer and the National Association of Statutory Health Insurance Funds (GKV-SV), with support from an arbitration body if an agreement is not reached within nine months after inclusion in the directory. If a manufacturer’s freely-set price falls below the limit of the 1st quartile of average DiGA prices and annual revenues do not exceed €750,000, further price negotiations can be bypassed27. If these conditions are not met, negotiations with GKV-SV involve the application of maximum prices. Manufacturers theoretically retain the right to set a higher price than the negotiated one, with end-users bearing the price difference. Concerning the criteria for price determination, the main factor should be the extent of proven medical benefit and/or pSVV. Currently, the translation of observed benefits into a value-based price largely depends on negotiations. However, the new DigiG aims to establish transparent quality competition: starting from January 2026, at least 20% of the remuneration of permanently included DiGAs will be value-based. Under this approach, prices will depend on specific success factors to be agreed upon between the GKV-SV and the manufacturers associations.

Given its aim of reimbursing DMDs as integral components of care processes rather than standalone technologies, the Belgian model plans to implement bundled payments whenever feasible. However, the global revision of care processes is recognized as a gradual undertaking, and mechanisms to define innovative value-based payment schemes are still under development. Despite the expected rise in temporary reimbursement adoption following the framework update, especially when temporary solutions are viable during a global care pathway revision, criteria for pricing mechanisms are still to be defined.

In France, the dedicated reimbursement mechanism for therapeutic DMDs under the PECAN framework was announced in April 2024 through an official decree28. The scheme features an initial flat rate of €435, including tax, per patient, invoiced for a period not exceeding three months, followed by a monthly tariff of €38.3, resulting in a maximum financial compensation of €780, including tax, per year per patient. For reimbursement under general law, the negotiation scheme applied to conventional MDs extends to therapeutic DMDs: the CEPS negotiates the price paid by statutory insurance, primarily matching it with the clinical benefit evaluation issued by the CNEDiMTS. Tariffs for remote monitoring DMDs have instead been outlined in a dedicated ministerial order29. These payments include an operator tariff for the healthcare professional performing telemonitoring (set at €11 or €28 depending on the expertise level) and another for the retailer or distributor offering the technical solution. Monthly flat rates for the device provider are set at €50 per patient for up to 4999 patients in the indication, regardless of the manufacturer and the reimbursement pathway (PECAN or LATM), decreasing thereafter. Payment by the French national health insurance is intended to be contingent on the actual use of the DMD under all reimbursement schemes.

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