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 payers, Pricing – planning, research, design, implementation and Price negotiation.