Integrated Care Models in Germany – potential Market Access route for Medical Devices?

Introduction: The 2004 introduced Integrated Care Models – ICM (§140 a Social Code Book), the German Managed Care, incrementally making share of the SHI healthcare expenditures. Recent research suggests integrated care models as a not yet spotted potential access route for medical devices and hence faster access to innovative diagnostics and treatment methods. However, the perception among stakeholders might be quite differential. The key question within the discussion is if the integrated care contracts could be an opportunity for market access which might overcome potential issues for market access through regular routes.

Methods: Integrated Care Models have been evaluated systematically through a triangulated approach – the analysis of model concepts, the organizational and contractual set-ups and by semi-structured interviews with key stakeholders.

Results: Most of the times integrated care contracts will only come into place when there might at least be a win-win situation between the industry and health insurance companies. The primary advantages are among others, the involvement of almost all decisive stakeholders of the healthcare system for market access and reimbursement. This eases demonstrably as well the successful application in regular approval routes across sectors. On the other hand, conflicting in this regard is the situation of the associations of statutory physicians which are not included by law as stakeholders for an integrated care models and only slowly discovering ways to participate. However, the budget control mechanisms on a regional level are major hurdles as by today and one part of the problem of discussion. Nevertheless, Integrated Care Models provide a potential market access route for medical devices through targeted product placement. ICM’s Medical Advisory boards have the freedom to include a product either under specific own managed budget lines in already existing contract or to include it by implementing new treatment procedures in the ICM. In addition, the systematic development of treatment procedures associated to the product leading to professional case management structures, potentially supporting guideline developments and overall show a reasonable fast access to these innovative medical devices.

Conclusions: Even though there is a still halting progress of ICM and the therefore quite sparse overall knowledge among all stakeholders, integrated care obviously appears as a quite promising access route for medical devices by bridging the often lengthy and challenging procedures across sectors but primarily in outpatient care, were the current regular route is often still a deadlock.