Market access of health apps for public health insurances in Germany – coming soon

The digital care act passed the German parliament and includes especially also the reimbursement of health care apps by German statutory health insurance funds. The process for market access will include an evaluation and registration at the German registration institution BfArM and thereafter a price negotiation with the Head Association of the Statutory Health Insurance Funds (GKV-SV). How these various steps will be detailed is still open. However, now the milestones are made public when the process steps will be published.

  • The draft legal framework will be published by the Ministry of Health in January. There will also be the opportunity of commenting the draft.
  • BfArM guidance on the details about the process, procedure, method and requirements are bing Mae available in February
  • The final framework and BfArM guidance is planned to be available in March 2020
  • From April 2020 onwards the BfArM online platform as well as the option for consultations will be up and running and also fast track submissions are then possible.

So, get started and prepared for reimbursement of digital apps in Germany.

MArS has experience in the AMNOG process which might be quite similar to the BfArM process and especially the price negotiations with the GKV-SV. MArS has also developed the MArS Negotiation Boot Camp utilizing latest technology including Virtual Reality in order to be optimally prepared for a successful price negotiation. Contact us!

Fast track access for apps into the GKV market in Germany

MArS attended the Medical valley Forchheim symposium on the market access pathway for new digital solutions (“apps”) into the statutory health care market. The new law will come into effect January 1 2020. Still open are the templates for the BfArM consultation and the price negotiation frame with the Head association of the statutory health insurance funds (GKV-SV). For the BfArM the regulations can be expected as the new law §33a para. 3 SGB V RefE is now publicly available. In case clinical evidence for a (patient) benefit is proven the app can be included in the BfArM registry / database, if that is not the case this can be provided within the first year of launch.

For the price negotiations MArS expects the regulation frame to be similar (but adapted) as within the AMNOG process. Core drivers will be the European prices (incl.out of pocket cost) as well as the clinical evidence on the product and comparable products. The template for the price negotiations are expected in the next few weeks. The arbitration board is not yet defined and built but is expected soon.

MArS offers the digital industry the experience in the process and contacts with German payers, the BfArM and especially with price negotiations with the GKV-SV. Core services to be provided will be Communication with payersPricing – planning, research, design, implementation and Price negotiation.