How fast is the DiGA Fast-Track?

Integrating innovations quickly and comprehensively into the German healthcare system was the goal of the DiGA Fast Track legislations introduced by Jens Spahn and the German Ministry of Health in 2019. Many digital health startups hoped for a faster and comparatively low-threshold access to the German healthcare system with the DiGA Fast Track. But have these expectations really been confirmed after more than two and a half years?

If you take a look at the DiGA process supervised by the German Federal Institute of Drugs and Medical Devices (BfArM), the steps and associated timelines are – at least in theory – clearly defined:

  1. Preparing for the application: Once the manufacturer is aware of its market access strategy and has checked itself – or with external support – whether the DiGA criteria for its application are fulfilled, a consultation with the BfArM is recommended. The aim of these consultations is to clarify open questions, to take into account the opinion of BfArM (e.g. with regard to studies) and to establish a personal relationship with the institute. The opportunity for a consultation provides a lot of benefits for the upcoming process, but should be well prepared by the manufacturer, as it is always associated with costs.
  2. Application: Once all questions have been clarified, necessary adjustments have been made and the required documents (e.g. study concept) have been prepared, the next step is to apply for approval. The DiGA application must be completed and submitted digitally via the online portal of the BfArM.
  3. Examination: In the next step, the BfArM examines the application for completeness and formal correctness. The institute has been granted 14 days for this process. If necessary, further information and documents can already be requested at this point, which the manufacturer can subsequently submit within 3 months via the application portal.
  4. Evaluation: Once the application is complete, the BfArM has a limited time frame of 3 months to review the documents. In this process, the general requirements as well as the proof of the positive supply effect (in the case of permanent admission) or the evaluation concept (in the case of preliminary admission) are examined in detail. At the end of this process, the decision on acceptance or rejection of the application is made. In the case of a decision for admission, the manufacturer is listed in the DiGA directory on the same day and the application is thus prescribable by doctors all over Germany.

Adding up this time, the admission to the DiGA directory seems to be possible within four to five months. But the reality for many potential DiGA manufacturers is different:

The process, which seems fast and simple in theory, contains many challenges and hurdles for the manufacturers, making the process longer, more arduous and more resource-intensive than initially expected – especially if the aim of the application is a permanent admission. Here are the most common time-drainers in the process:

  1. Strategy: While the DiGA Fast Track was initially traded as THE market access option for digital health solutions, it is becoming apparent that it only works for a very specific group of applications. If the manufacturers application belongs to this group needs to be evaluated at an early stage, paying particular attention to evidence, patient groups, and physician involvement. Therefore, the following questions are needed: Can I prove my endpoints in a clinical trial? Are validated questionnaires available? Which control group can I use? Can a confirmed diagnosis be made? Will my solution work as a purely digital application? To answer all these questions, time and expertise are two indispensable factors.
  2. Bureaucracy: Making an application seems simple at first. However, the pitfall is in the detail and the requirements have increased significantly since the birth of the DiGA Fast Track in 2019: Not only do manufacturers have to answer “yes” to all 165 questions of the general requirements, but the following study concept must already be valid. Additionally, the systematic data evaluation, which is necessary for a preliminary admission, should not be underestimated. For permanent admission, the retrospective comparative study – and thus a high level of evidence – has established as the gold standard.
  3. Assessment time: Even if a fixed time frame of 3 months is provided for the evaluation, this should not be the time frame expected for an admission. The experience of recent years shows that an application is always accompanied by queries and subsequent demands in the form of deficiency letters by BfArM. Far too often a complete resolution of the demands by the manufacturer is not possible within the remaining time and a withdrawal of the application becomes necessary.
  4. Reapplication: In the case of a re-submission, the process starts from scratch and necessary adjustments, counselling interviews, and renewed deficiency letters may be the result. Additionally, the BfArM has another 3 months to review the new application.

Thus, four to five months can quickly turn into one to two years to get from the initial strategy to the final admission of a DiGA. It is therefore even more important for manufacturers to keep an eye on this realistic timeline to secure financing and calculate the required resources correctly. Solid strategic groundwork and market knowledge are the foundation of a successful market entry. Working with experienced DiGA applicants and manufacturers can  help speed up the process and avoid setbacks. If these challenges are taken into account, the DiGA fast track is and remains a promising approach for digital health applications to quickly gain a foothold in the German healthcare landscape.