From DTx in Germany to a pan-European Approach


DTx and DiGA, two acronyms of strategic importance in digital health

As digital therapeutics (DTx), a key use case of digital health innovation, makes headway in the US, how the EU will integrate and reimburse DTx is of strategic importance to healthcare. At the annual Frontiers Health conference, the status of DTx in Europe and the possible establishment of a pan European reimbursement framework was a featured topic.

In 2019, Germany one-upped the European digital health movement with DiGA, a go-to-market process, that paved the way for the reimbursement of digital health applications in Germany. We were surprised, as a community, by how fast the initial DiGA implementation took place, since  we are used to the slow pace of change in healthcare and insurance organizations. Since then, more than 20 of the eligible digital health applications have been reimbursed in Germany.


The need for further refinement before templating a DiGA-like process

While the German DiGA Fast Track indeed went fast, as a community of digital health investors, entrepreneurs and policy experts, we observed that the process could be even more effective as a DIGA 2.0. But what do we need to change? Hannes Klöpper, CEO of HelloBetter, shared the challenges his company faced in obtaining a permanent DIGA listing of their Stress and Burnout mental health program and the learnings that we can take away.


The Fast Track in its current form allows for products to be listed either “preliminarily” or “permanently”. Products that apply for preliminary listing have to produce evidence  of effectiveness, applying a randomized protocol (RCT), within a ‘grace period’ of 12 to 24 months after theafter the initial listing. To be listed permanently, companies need to provide rigorous RCT evidence upfront – documented in accordance with ISO 14155.  A first recommendation would be that these requirements be spelled out in greater detail, so that companies know what to expect. For example the unclear definition of permissible human guidance caused a headache for many companies. Ideally, including a coaching component should be allowed not just for patient security, but also to bolster adherence and efficacy. Moreover, acceptance criteria of a given methodology or therapeutic approach for one application should then, to ensure fair competition, be applied equally to all subsequent applications.


While high quality standards are clearly necessary, rigidly applying the formal ISO requirements currently applied to pharmaceutical market access studies, as to clinical studies that have been conducted in an academic context, would disqualify many perfectly valid studies. Given the novelty of digital health, much of the existing evidence comes from academic research, wherein each institution defines the formal requirements slightly differently. It is not in the public interest to require companies to re-do clinical studies in order to align on those formalities, as this will create a time disadvantage for European digital companies on their way to market.  Of course, if existing evidence is found to be insufficient, companies should be allowed to switch lanes from permanent to preliminary, in order to save time. Within the list of approved Digital Health Applications, the distinction between those products that are listed permanently and those that are not; should be made clearer to reward products that have successfully produced high-quality evidence.


The evaluation period, currently fixed to three months, is a double-edged sword. While speedy decision-making is important to startups, extremely short, sometimes unrealistic deadlines to respond to requests for information put extreme pressure on everyone involved. Transparent, timely and detailed communication about the status of a given application and the potential issues that remain to be resolved, would allow for a smoother process on both sides. 


Last but not least, we should think beyond the listing process. Ultimately, a European DiGA will only be a success if the products that are listed actually end up being used by patients. Hence, the professional education and remuneration of doctors should be included in every national implementation strategy.


France has a new digital health infrastructure and a second mover advantage

As was pointed out by Lina Behrens of Flying Health, Germany is not alone in seeing the need for this kind of framework. At the Digital Medicine Conference in Berlin, just the week before Frontiers, seven EU nations presented their current status of digital health regulation and possible plans for further developments, often inspired by the German system. Particular excitement was placed on France following President Macron’s recent statement to instate a DiGA-like process in France.


Concerning DTx reimbursement in France, Denise Silber, CEO of Paris-based Basil Strategies digital health experts, confirmed that the 2022 health financing law is expected to include two articles providing for a DiGA-like one-year initial reimbursement of both DTx and remote monitoring applications. She added that France has been accelerating its adoption of a start-up mentality under the current presidential mandate. Iconic spaces housing accelerator and incubator programs have opened. Public and private investment in digital have increased significantly. Etapes, a 5-year chronic disease remote monitoring experimentation has exposed professionals and patients in all regions to the benefits of digital health. And surveys show that professionals and the public are much more favorable to digital health tools than in previous years.


The adoption of a national health identifier and a massive software updating project have laid the groundwork for the opening of a government-run online “My Health Space.” This new digital space will provide all French citizens with their electronic medical record and the option to use approved medical applications from 30 companies. The French presidency of the European Union begins on January 1, 2022, also the date of the My Health Space launch, and it is expected that France will seize the opportunity to pursue its efforts in favor of a pan-European DTx approval and reimbursement.


A rapid start for Italy

Our discussion took place in Milan, Lombardy, Italy, home to Elisabetta Ravot, Head of Science at Healthware Group, a leading healthcare consulting agency. Italy is also moving ahead, laying the groundwork for the implementation of an Italian DIHA framework. The foundational act of the Italian movement, which was initiated in 2019 by the “DTx for Italy”-project  promoted by Fondazione Smith Kline (FSK), involved a multidisciplinary panel of 40+ national experts of digital health, with the objective of guiding the research and development of DTx in Italy and facilitating its entry into clinical practice.

The first outcome of this group, led by Giuseppe Recchia (FSK) and Gualberto Gussoni (FADOI), was a “white book”, presenting a detailed analysis of the conditions required to design and implement an Italian framework. The recommendations of the panel position the German model as a template to adapt to the Italian system. One major difference between the two systems is the responsibility for medical devices and drugs in Italy which is split between two different institutions (the Ministry of Health and the Italian Drug Agency) while the German BfARM encompasses both. Nonetheless, many recommendations from the Italian panel are universal, such as: the need to develop appropriate information and education programs for professional, patients and the general public; the need to involve patients in the research and development process; the involvement of the European Medicine Agency (EMA) in the clinical validation of studies either comparing DTx to a control drug or where the submitted indication for a DTx is comparable to that of a drug. 

Currently, the Italian project is moving into its second phase, a call to action to health and political institutions, to accelerate the draft of an Italian Digital Care Act including DTx. 


Will there be a European framework?

Having spent her last few weeks participating in policy making and the sharing of learnings on behalf of our communities in several countries, Lina Behrens provided essential insights on the European movement.

At the Digital Medicine Conference in Berlin hosted by the German Ministry of Health, the German health innovation hub (hih), the innovation arm of the Ministry, proposed 5 questions which would constitute a framework for the harmonization of the digital health go to market process across Europe:

1. Market access: How is access organised?

2. Application of manufacturer: How is a digital health application defined?

3. Evidence generation: Do we agree on the same requirements across the EU?

4. Reimbursement structure: Preliminary access? Who pays?

5. Price negotiation: Who negotiates how?


The EU DiGA Con – part of the Digital Medicine Week – kickstarted the discussion among European experts to find possible answers to these questions. Whilst step 1 (market access) is already primarily organised on an EU level, with the Medical Device Regulation (MDR) and General Data Protection Regulation (GDPR) in place, we see room for further harmonization in step 2 (”application of manufacturer”), and even more so in step 3, (“evidence generation”). he European Council is taking a first step in this direction, by harmonizing approaches to a European HTA approach, but more work needs to be done for full harmonization. Steps 4 and 5 are currently solved on national levels, and will most likely see advances on a country by country level in the near future, before addressing an EU wide reimbursement structure and/or price negotiation. 


Following President Macron’s statement to implement a similar digital health track in France, the European Knowledge and Information Community EIT Health and the French Ministry of Health invited an expert group to Paris, in the days preceding Frontiers Health,  to share their learnings from France and Germany. The open discussion involved policy makers, regulators, digital health entrepreneurs and consultants. Topics included approaches to pricing and the pro’s and con’s of price limits, ways to facilitate a Europe-wide evidence framework for digital health, and how to include risk classes IIb and III. Learnings from the first year of DiGA in Germany were shared and critiqued, to help optimize the ongoing French implementation process.


Harmonization is within our grasp 

As the EU matures  year after year, there is more harmonization of policies and laws – and the results are more effective. Examples include the GDPR which caused the introduction of unified privacy laws, the Payment Service Directive v 2 (PSD2) which removed major hurdles for payment services. We hope that the European standard framework for Health Technology Assessments, which would have a huge impact on our field, will soon be launched as well.


Policy makers are generally more used to pharmaceuticals and physical devices. As stakeholders in the DTx movement, we must take the time and effort to educate both policy makers and ourselves, in order to pave a smooth road for our industry.


A pan European framework for reimbursement of digital health applications is within our grasp. The steps to get there are fairly clear. Let’s turn it into a reality.