Flyer Roadmap

6 Co - financing decision Do you want to accept only the statutory co - payments and otherwise obtain full reimburse- ment from the health insurance funds? Or is one prepared to accept fixed amounts, maximum reimbursement amounts or even on- ly partial reimbursement? Depending on the financing decisions, several options open up for designing the road map to market access. Modules of the Road Map to Market Access In principle, the Market Access Road Map for pharmaceuticals differs considerably from that for medical devices or diagnostics. The reason for this is the different legislation in each case. Beyond the different categorization, the design of a road map depends on whether it is a pre - or post - launch road map or a comprehensive integral road map. Depending on the type of road map, the respective operational modules are then combined. Market access modules Market access modules are primarily approval - relevant processes, such as a CE certification in the area of medical devices or the approval number in the area of pharmaceuticals. Distribution modules In order to ensure saleability, a PZN is often required. If this is not applied for and assigned in good time, the product will not be found in the relevant computer systems of the phar- macies. The timely application for an institute code (IK) is also often forgotten. Without this, how- ever, it is not possible to participate in the electronic billing procedure of the GKV funds. Assessment and reimbursement modules This module represents the core area of the road map to market access. A distinction must be made here according to the product category, because for drugs, the evaluation is car- ried out by IQWiG and the G - BA via the early benefit assessment according to § 35a SGB V . For medical devices, the assessment procedure is more or less left to the MDK/MDS or the health insurance funds or their associations. The so - called "notified bodies" also play an important role. However, with the benefit assessment according to § 137e SGB V , a new, more formal as- sessment procedure has been introduced since January 1, 2013 for medical devices, in par- ticular for those of class IIB and III and "drug - related" medical devices.