Digital Health Market Access - Germany

The new legislation for digital health reimbursement in Germany, currently under implementation, provides the largest single opportunity for digital solutions globally.

  • If you are interested to learn more about this, we recommend this recent webinar which is available as a recording, where we provide a description of what is known.
  • By end of February, where we anticipate that the final legislation will be defined, we will have a new webinar to describe the new information. Register here.

There are important details regarding the legislation that has not yet been defined but based on what is known there are important actions you can take as a company.

In the new legislation there is a new term “versorgungseffect”, which best is translated as a ‘positive care effect’. This open up for other type of benefits than the traditional hard outcomes that the evaluator will require.

  • We can help you evaluate what outcomes that may be relevant for your digital solution to demonstrate a benefit in the “versogungseffect”

The new legislation will provide an opportunity to develop evidence during 12 month after the introduction on the German market. This may create a very valuable opportunity to improve the time to market. However, unless you properly understand the evidence that will be required by the end of the period, you may be excluded. Even though they allow you to develop additional evidence during this period, there is still a requirement to have a plausible effect at the start of the process.

  • We can help you develop a strategy of how you should have the necessary evidence at the start of the process and that you have a strategy for how to develop the additional evidence to ensure a successful reimbursement process.

Once the template for the reimbursement application has been defined, we can support you with the application.

Contact us if you want know more about how we can help you.