German legislation for digital health creates opportunities, start preparing
30 Jul 2019

Recently, a draft legislation was issued in Germany which stands to be an important door opener for the use of digital solutions. However, many key questions still need to be clarified in the implementation and these are not likely to be confirmed until next year. Here is a link to the current status and information about the next steps.

In this blog-post we aim to highlight some issues that are essential to prepare for this new legislation. These issues are based on the below key-points:

  • The digital solutions should be able to demonstrate a “positive healthcare effect”,
  • Their benefit could either be demonstrated at start or after 12 months (in some exceptions 24 months) and possibly using real world evidence.

This may at first appear to be an attractive and rather straight forward proposition. However, it raises substantial questions that require advance preparation.


Which relevant outcome will demonstrate the healthcare benefit?

In the context of reviewing clinical benefits for payers, the focus would be on hard, health outcomes such as reduction in mortality, morbidity, adverse events and quality of life. Here are some articles that cover this topic:

  • Fischer, Katharina Elisabeth, Thomas Heisser, and Tom Stargardt. ‘Health Benefit Assessment of Pharmaceuticals: An International Comparison of Decisions from Germany, England, Scotland and Australia’. Health Policy 120, no. 10 (1 October 2016): 1115–22.
  • Staab, Thomas, Georg Isbary, Volker E. Amelung, and Jörg Ruof. ‘Inconsistent Approaches of the G-BA Regarding Acceptance of Primary Study Endpoints as Being Relevant to Patients - an Analysis of Three Disease Areas: Oncological, Metabolic, and Infectious Diseases’. BMC Health Services Research 16, no. 1 (14 November 2016): 651.

Should the digital solutions have the same methodological requirements as drugs and devices, it will be rather difficult to demonstrate relevant improvements. Therefore, with the new term “healthcare benefit”, we anticipate that there will be other ways to define the outcomes, although how this will happen is still unclear.

Our recommendation is for companies to thoroughly analyse what may be the relevant outcome of their digital solution for specific diseases. To support this process, we have a methodological framework to evaluate and assess this.


The method to demonstrate the benefit and study design

It is intriguing that until the final decision about reimbursement is made (Coverage with Evidence Development), there is an initial grace period where evidence is not required, not even the potential use of real-world evidence. Generally, the use of digital solutions involves multiple evaluation approaches, since they have different modes of actions. Please read this prior blog about the Model for Assessment of Telemedicine (MAST) framework for evaluating digital solutions

It is complex to develop studies that accurately capture the value of digital solutions, either as traditional RCT’s or through the use of real-world-evidence. Therefore, we  strongly recommend the impacted organisations to start preparing by evaluating different options of designing a traditional clinical or observational study to demonstrate the healthcare benefit early on. Many studies will likely propose starting well in advance, prior to the initial submission in order to get a chance to demonstrate a benefit at the post-launch evaluation.

Contact us for more details about the framework we have which can help evaluate the different options to prepare for the study execution.