Part III: Room for enhancement and learnings from European neighbours
The launch of the German fast track pathway for digital health technologies – DiGA [1] - has been met with lots of excitement. It is considered a pioneering initiative that could advance the use of digital health technologies in Germany and could serve as a model for other countries [2]. However, so far, its penetration rate is still low [3], and the DiGA directory curated by the Federal Institute for Drugs and Medical Devices (BfArM) does not yet adequately cover the wide spectrum of relevant chronic disease indications including diabetes and cardiometabolic disease.
As we have discussed in the Part II of this blog post series, there is some room for improvement for the DiGA Directory to make a real impact in the treatment of people with diabetes. So far, from all 30 apps included in the directory, just two are tailored for people with diabetes. The ESYSTA App & Portal DiGA is currently provisionally listed in the DiGA directory, i.e its positive healthcare effect is currently subject to evaluation within a clinical trial [4]. ESYSTA targets people with diabetes who are on insulin therapy. This DiGA provides an automatically kept diary importing data from insulin pens and the self-measurement of blood glucose concentrations. Accordingly, DiGA components include a smart insulin pen (with Bluetooth functional technology), a smart blood glucose meter (lab), as well as a basis/app on the part of the patient and a portal enriched by analytical tools. The diabetes team and the patient can use the portal jointly to evaluate the success of the treatment and to initiate possible therapy changes.
HelloBetter Diabetes & Depression targets people with diabetes and depression. This DiGA is permanently listed in the DiGA directory [5]. Its positive healthcare effect is considered adequately proven by the Federal Institute for Drugs and Medical Devices (BfArM) based on the evaluation of clinical trial outcomes [6]. This app is based on cognitive behavioural therapy strategies and provides a twelve-week online course for diabetes and depression. Two provisionally listed DiGAs are available for people with obesity. Oviva Direkt für Adipositas [7] and Zanadio [8] support multi-modal obesity therapy by adding digital support tools with a behavioural therapeutic targeting of health relevant habits. While the inclusion of all these four DiGA can be acknowledged as a very good starting point, the inclusion of additional DiGAs and the consideration of relevant higher-class (MDR) diabetes technologies in the future should be seriously sought.
Other European initiatives fostering the usage of Digital Health Technologies
In the UK, the National Institute for Health and Care Excellence (NICE) developed an evidence standard framework for digital health technologies (DHTs) available for patients free of charge [9]. It involves different levels and types of evidence standards and balances risk-benefit ratio with cost-intensity. Conducting comparative randomized clinical trials are among the evidence for effectiveness standards. Similar to the digital health technologies applying for a DiGA, the proof of effectiveness has to be conducted in a location related to the national health and social care system. The main differences between both systems reside in the need of evidence of economic impact relative to the financial risk to justify the costs, the need to prove medical benefit without any “provisional phase” and no device class limitation for DHTs commissioned in the UK.
Belgium, on the other hand, has designed a platform (mHealthBelgium) aiming at consolidating information about DHTs for patients, healthcare professionals and institutions [10]. It is a validation pyramid of three levels for DHTs CE-marked as medical devices. All devices enter the platform at the first level. In this stage, the app has to already bear a CE mark, and the Federal Agency for Medicines and Health Products (FAMHP) checks if the device complies with the rules and regulations for medical devices and the EU General Data Protection Regulation (GDPR). To reach the second pyramid level, DHTs have to submit a risk assessment (performed by an independent organization) proving they meet all criteria regarding data authentication, security and interoperability. The third level of the pyramid is reserved for apps that have proved a social-economic benefit. The National Institute for Health and Disability Insurance (NIHDI) reimburses just the use of apps that have reached the third level. So far, there are 23 apps at the first level, 7 of which were developed for patients with diabetes; 11 apps at the second level, 4 of which for patients with diabetes; and to date, no app has reached the third level.
How could we foster the usage of DiGAs?
The under-representation of DiGAs tailored to patients with diabetes and cardiometabolic disease might be a consequence of the challenges brought by the new European medical device regulation (MDR) associated with the limitation of medical device classes that can qualify as DiGAs. If we take the Belgium model as an example, there are already 11 apps treating diabetes listed in the mHealthBelgium platform. It seems that the absence of a limit of medical device classes that can integrate the platform, offers patients suffering from diabetes vaster options of validated DHTs. The fact that it might take years before the DHTs can be reimbursed does not seem to discourage manufactures.
In addition, the mHealthBelgium and the NICE initiatives have something else in common that could help improving GKV’s prescription and acceptance of DiGAs, including those targeting diabetes. In both frameworks, digital health technologies have to show medical benefit and an added economic benefit to be reimbursed, while DiGAs can set up their own price and be reimbursed for a period prior to proving medical benefit. It seems that GKV’s criticisms are understandable. DiGAs should have to prove medical benefit before being reimbursed, or at least have to adhere to a maximum price model while gathering enough clinical data to prove their benefit.
The proof of safety and medical benefit should be based on early-randomised clinical trials performed in well-controlled clinical research environments. Subsequently, manufacturers and care providers could conclude performance-based managed entry agreements (MEAs), aligning the amount of reimbursement dynamically with the outcomes measured in settings of value-based healthcare [11]. MEAs would allow a supervised earlier implementation of DHTs in diabetes care while some insecurities regarding their impact on care effectiveness and cost-efficiency still stand.
Both EASD and ADA expect that the integration of well-designed and evaluated diabetes DHTs into patient treatment might improve diabetes management considerably [12]. The diabetes field holds the promise of unfolding the full potential of DHTs to improve treatment outcomes and saving costs as diabetes can be seen as a data management disease. Patients with diabetes are forced into making data based decisions on a daily basis [13], which offer a high potential for DHTs to not only act as add-on to guideline-compliant therapies, but also substitute analog therapy regimen prone to human error.
The DiGA fast track could be a starting point for the development of a fast-track pathway for higher risk classes of DHTs that treats chronic diseases such as diabetes and cardiometabolic disease. The integration of clinical diabetes research with clinical diabetes care [14] and health economic modelling [15] could allow the adjustment of the level of reimbursement of diabetes DHTs according to the levels of effectiveness evidence achieved in real-world diabetes care settings.
A modification of the framework conditions allowing the inclusion of higher classes of DHTs or the design of a fast track directory for these devices would have a tangible impact on patients’ health and patient-reported outcomes. People with diabetes and cardiometabolic disease are among chronic patients that will benefit most from the prescription of DHTs. 