Conception of the German market access for two innovatice products

The medical devices were meant to become part of an integrated care solution: operated in a specialized clinic, subsequently serviced in specific centers and with processors regularly updated by the manufacturers, the reimbursement options within the existing G-DRG-system at the treating hospital had to be taken into account as well as the remuneration mechanism of the post-treating service centers.

Together with an international team, SKC was assigned to identify the product specifications and to evaluate and concretize the appropriate reimbursement paths.

The comprehensive solution included the following aspects:

• Analysis and evaluation of price, cost and reimbursement mechanism for active implants in the German market
• Identification of the specific demands/requirements of the German market including legal frameworks
• Compilation and evaluation of the significant stakeholder groups
• Development of a pricing model
• Analysis of the key value levers
• Systemization and quantification of the new product's differentiating features
• Illustration of implications for market entry and portfolio strategy: including the adjustment of the R&D strategy

Key success factors for the implementation and reimbursement were identified and addressed. Based on the project results, the reimbursement eligibility of the products was relativized, the product features were adapted in the further course, and the measurability of the benefits for the different participants in the reimbursement procedure (InEK, DIMDI, hospital, specialized associations) was increased.

The research and development strategy was adjusted and was extended by adding the needs for the subsequent benefit assessment. This was achieved by anticipating the requirements of an evidence-based evaluation.