The Digital Care Act opened the door for more digitization in healthcare by making the “app on prescription” prescribable. However, in order to increase the acceptance of DiGAs, health insurers, physicians, DiGA manufacturers and associations are calling for improvements in the approval process.
The results show that the players involved are surprisingly close to each other, especially when it comes to the topic of “medical benefits”.
It is an obvious conclusion that more digitization – especially in healthcare – is a legislative task. This is of course partly true, but it ignores the possibilities that the Digital Delivery Act (DVG) already offers today. With digital health apps (DiGA), a tool is on the table to bring digitization to patients. The problem: The apps on prescription are still little prescribed.
The key role played by the DiGAs can also be seen from the fact that the largest stakeholders in the healthcare system – patient and physician representatives, health insurers, but also the DiGA manufacturers – have all officially positioned themselves on the occasion of the interim review after two years. The fact that the assessments differ depending on the perspective is part of the pluralism: The manufacturer side (e.g. start-up representatives) sees regulatory hurdles that are too high in some cases, health insurance companies see an imbalance compared to other service areas, especially in the preliminary DiGA listing in the fast-track procedure due to the evidence that has not yet been conclusively proven, and demand improvements, and physicians feel that they are not sufficiently informed overall. These are all valid points of criticism and necessary lessons learned that do not indicate irreconcilable differences – as long as they are taken seriously by everyone involved.
But first things first: As of today (as of June 28, 2022), a look at the DiGA directory shows 32 apps, 20 of which are still under provisional listing, while 12 apps already carry the “permanently approved” label. Only two apps – the migraine app M-Sense and the psychosomatic app Mika – have so far been removed from the list. The figures tell us two things: that the approval process, including preliminary approval, is basically working, but also that the final evaluation is still pending for the vast majority of apps.
In addition – and the DiGA directory does not provide this figure – the number of apps could be significantly higher from the perspective of the start-up ecosystem as a whole.
As a companion to many different DiGA projects, the Medical Valley Digital Health Application Center (dmac) can confirm that this test is anything but easy. This is also borne out by the figures: Compared to 32 applications that made it into the directory, eleven received negative decisions and more than 60 manufacturers withdrew their applications, sometimes because of the challenging regulations.
The approval practice may give many providers sleepless nights, but it should also be seen as a seal of approval: After all, in view of the strict process, no one can speak of a “wave through”.
The reasons for withdrawing digital health applications from the approval process are many. In addition to the high requirements for proof of evidence, factors such as information security or other technical requirements also play a weighty role. At this point, it would already bring a noticeable improvement if the Federal Institute for Drugs and Medical Devices (BfArM), as the authorizing body in the evaluation process, were to communicate early and more transparently which review criteria the application cannot withstand. The earlier in the process this is communicated, the greater the chance of submitting the necessary documents, data, etc. later. The chances of success of the companies that currently withdraw their application for listing in the DiGA directory due to the often very short response times towards the end of the evaluation process, especially with regard to the results of the systematic data evaluation, could certainly be significantly increased in this way. In this way, it may be possible to focus the DiGA approval process even more on what is most essential for patients: medical benefits.
If you look at the statements of the various players, you will see that the demands are not that far apart: At the heart of the matter is more or less always the approval process. For example, in its call for a “statutory update,” the GKV-Spitzenverband complains that scientific proof of the positive care effect must be guaranteed by the app providers. Currently, this must only be proven after a period of one year (i.e. after approval via “Fast Track”), or at least it must be possible to prove it with a high degree of probability in order to obtain an extension of the period by a further 12 months. At the same time, health insurers would like to see a cost structure based on applications that are not listed with the BfArM. However, as with other medical devices, the costs for DiGAs are incurred because manufacturers had to make high initial investments in the approval process in order to be included in the list in the first place. Health insurers and app providers therefore both have an interest in an approval process that is geared even more to the essential factor of “benefit”.
And the group of service providers – i.e., primarily physicians – also argues similarly in parts: according to a broad-based survey on DiGAs conducted by the Stiftung Gesundheit, namely, just under half of physicians openly doubt the efficacy of the applications that have so far only been provisionally included in the DiGA directory. They refrain from prescribing just because of that. In addition, there are long-standing relationships and trust between doctor and patient. Doctors are therefore often very aware of individual life situations and motivations and therefore see no reason to add digital applications to existing prescribing practices, even though the increasingly digital world in which patients live and work is also opening up new opportunities here.
This is a tough nut for technology vendors and service providers to crack in one fell swoop. Here, the DiGA manufacturers are specifically asked to explain their apps better and more transparently and – again – to place the benefits at the center of their argumentation in order to thereby also increase trust among patients.
For patient advocacy groups, it is particularly important that no one is excluded from using a DiGA, that access is barrier-free, and that appropriate training and support services enable safe use.
Despite all the differences in the way the DiGA issue is viewed, it is clear that all those involved would like to see a higher prioritization of the positive supply effect in the assessment by the BfArM and that “not downloads but therapeutic benefit” is paid for, as Stefanie Stoff-Ahnis, Executive Director at the GKV umbrella organization, demands. Start-ups or DiGA manufacturers can also rally behind this goal if the “fast track”, which is existential for them, is maintained. It is a characteristic of software products that they only provide the necessary empirical values in the field.
However, the approval rate would increase significantly if startups knew earlier what pitfalls they would face, for example, in data protection or the evaluation of pilot data. More transparency from BfArM and clear, early, proactive feedback in the process would help identify problems early and respond to them in the application process. If all institutions involved in the DiGA approval process focus on the strengths of the DiGA tool and work together to improve the process (e.g., by increasing commitment to meeting deadlines and requirements), it would further increase predictability for manufacturers, allowing even more applications to cross the finish line. Through more standardization and shared experience, of which more and more is now becoming available, the entire ecosystem – DiGA manufacturers, health insurers and providers – can benefit, further reducing bureaucracy and focusing on the issue that comes first for everyone: The benefit to the patient.
You can find the full article on devicemed.de.
