How will the payer view the value of a digital solution in Germany?
Coming back after an intense and inspiring day in Heidelberg about the new regulation for reimbursement of digital health I am very encouraged to see the way the issues is being addressed still recognising there is a long way to go.
There are many issues to be considered in regard to the new regulation, but after hearing the discussions there are two key issues relating to how the new digital solutions will be valued in the negotiation with the insurance companies.
Traditional or new outcomes?
With the new draft regulation of the process, there is more clarity about the types of outcomes that are relevant in the evaluation.
Traditional outcomes:
- Improving the medical condition
- Shorting the duration of the disease
- Improved survival
- Improved quality of life (such as measured by rather abstracts questions compared to interpretation of how the concept of quality of life would be considered in everyday use)
New outcomes related to health care benefit (Versorgungseffekt)
- Co-ordination of treatment process
- Alignment of treatment to guidelines and other recognized standards
- Adherence
- Improving access to care
- Patient safety
- Health care competence
- Patient sovereignty
- Managing with disease related challenges in everyday life
- Reduction in health care resource utilisation and burden for the patient and relatives
There is a need to evolve the selection of outcomes that we measure and evaluate in the assessment in Digital health solutions, the question is how the payer will view the value of the different types of outcomes when it comes to the negotiation of the price.
Adherence is an established factor that has a significant impact on the outcome of many diseases and is as such likely to have a relevant value in the healthcare setting. However, I would guess that unless it is possible to demonstrate how the adherence has a meaningful impact on the traditional outcomes in a specific disease, that it will be hard to justify an attractive price in the negotiations?
Study design and setting
The regulation outlines that the digital solutions should demonstrate superiority against standard of care, which is a rather high-level evidence requirement. The regulation allows for a 12-month post-introduction study period to complete any clinical study. The use of real-world-data is discussed, but in a German context the ability to do high quality study is unfortunately rather limited due to the strong data privacy laws and the difficulties to access real-world-data(RWD).
The regulation allows studies from other countries within the European Union without any justification and studies from outside union if a justification can be given for the relevance of the practice in Germany can be justified.
Even though the legislation allows for data from other countries, I believe the value of the studies will reduce the potential value unless they are very well designed and there is a justification of why the result is relevant in Germany.
There are many scenarios where data could be used from more RWD friendly countries like the Nordics and where there are ways to provide a solid justification for the use in Germany. We can provide data to create a comparative arm based on a patient cohort of about 1,4 million patients very quickly.
We have a webinar on March 6th with an update about the Digital Health Regulation in Germany.
Don’t hesitate to contact us if you need support in Germany for your digital health solutions.