Germanies „fast track“ to More Access for Health Care Apps

In recent months, there has been plenty of buzz generated around the Digitale Versorgung Gesetz (DVG), a new law promising a fast track to reimbursement of digital solutions within the German Statutory Healthcare System (SHI) -- and that buzz is for good reason.

 

This system provides coverage for 90 percent of the German population. The law itself aims to create a catalogue of digital health solutions to be covered by the statutory system and prescribed by physicians. In order to get listed in this catalogue, solution providers have to prove, with comparative studies, that they address a significant challenge in the system, and that they actually deliver what they promise.  

If these companies don't have the evidence needed to substantiate their claim upon application, they have the opportunity to develop scientific evidence within 12 months and have their solution reimbursed in the process. If the evidence confirms the benefit, the solution stays in the catalogue; if it doesn't, the solution is removed from the catalogue and can no longer be prescribed. Naturally the first cohort of applications was quite long but so far only 22 have officially submitted at Germanies Federal Institute for Drugs and Medical Devices. It is save to believe that startups, that have been already in the market for several years – such as the symptom-checker Ada, or the e-mental-health startup Selfapy - have the best chances to get accepted on the reimbursement-list. 

So far, with this approach Germany is pretty much alone in reimbursing the cost of digital health apps and its startup-friendly health minister Jens Spahn hopes that Germany can also become a European leader in the digital healthcare transformation. Venture capitalists and startups in Germany believe that the new rules will benefit the startup ecosystem and allow healthtech startups to get enough of a critical mass to take their products global. 

It's a tricky balance to strike: promise too little and your solution is deemed irrelevant or classified at a low price point in negotiations with German payers. Promise too much, however, and you might not be able to provide the evidence to substantiate your claims. In this session, we want to examine "Care Delivery Improvements" in the context of the DVG and discuss specific challenges and best practices in evidence development for digital health solutions.  

 

This system provides coverage for 90 percent of the German population. The law itself aims to create a catalogue of digital health solutions to be covered by the statutory system and prescribed by physicians. In order to get listed in this catalogue, solution providers have to prove, with comparative studies, that they address a significant challenge in the system, and that they actually deliver what they promise.  

If these companies don't have the evidence needed to substantiate their claim upon application, they have the opportunity to develop scientific evidence within 12 months and have their solution reimbursed in the process. If the evidence confirms the benefit, the solution stays in the catalogue; if it doesn't, the solution is removed from the catalogue and can no longer be prescribed. Naturally the first cohort of applications was quite long but so far only 22 have officially submitted at Germanies Federal Institute for Drugs and Medical Devices. It is save to believe that startups, that have been already in the market for several years – such as the symptom-checker Ada, or the e-mental-health startup Selfapy - have the best chances to get accepted on the reimbursement-list. 

So far, with this approach Germany is pretty much alone in reimbursing the cost of digital health apps and its startup-friendly health minister Jens Spahn hopes that Germany can also become a European leader in the digital healthcare transformation. Venture capitalists and startups in Germany believe that the new rules will benefit the startup ecosystem and allow healthtech startups to get enough of a critical mass to take their products global. 

It's a tricky balance to strike: promise too little and your solution is deemed irrelevant or classified at a low price point in negotiations with German payers. Promise too much, however, and you might not be able to provide the evidence to substantiate your claims. In this session, we want to examine "Care Delivery Improvements" in the context of the DVG and discuss specific challenges and best practices in evidence development for digital health solutions.