Medical Technology and Biotechnology
The path to reimbursement
Though there are numerous efforts at the pan-European level to unify and standardize reimbursement processes, reimbursement currently is based only on specific national regulations. There are manifold of paths to reimbursement for medical technology in Germany. They differ both in their contentual and formal requirements, as well as in their success and profit potential.
Medical technology and biotechnology companies should ask themselves:
- How must I classify my product or software, and which strategic challenges await me during market access?
- Which regulatory requirements do I need to meet, and what options are available to move towards reimbursement?
- Do current studies meet the requirements?
- To what extent can I prove benefit?
- How can the advantages of my medical product be best demonstrated?
- What effect does the current "standard of care" have on pricing?
Target-oriented from the beginning
A key factor in successful reimbursement is the pursuit of a mature strategy during the development or certification process. In doing so, knowledge of regulatory requirements are of great importance. The detailed reimbursement process depends on the risk class of the medical product or currently applicable medical product regulations, for instance. In order to mobilize as quickly as possible on the market, it is important to evaluate the various options with regard to implementation potential and any barriers to the market access process in detail. Only those who know the specific clinical pathways and the actors within this environment can develop a product optimally and market it successfully through the use of a value story.
With experience and knowledge
SKC has extensive experience with reimbursement mechanisms, in particular in Germany, which is the largest market for medical devices in the EU. In addition, due to our year-long activity in the health sector, we know the relevant agencies, such as
- the German Federal Ministry of Health,
- the German National Association of Statutory Health Insurance Funds (GKV-SV),
- the German Federal Joint Committed (G-BA), and
- the Institute for the Hospital Remuneration System (InEK).
We jointly develop market access strategies or provide modular support for individual process steps, depending on the objectives of our clients: Beginning with the creation of a "reimbursement roadmap", to evaluating reimbursement options as well as the development of a product-specific value story, all the way to the analysis of methods, we provide our clients with individual services.
Providing a general overview over the German reimbursement system, basic conditions and innovations, and identifying the steps required for reimbursement qualification in Germany
Identifying potential paths to reimbursement and/or evaluating reimbursement in selected pathways (stress test including substantive and formal requirements, gap analysis, and suggestions to optimize product positioning)
Developing a product-specific value story as the basis for argumentation with respect to the various interest groups
Guidance and support for the process of method assessment (§135 & §137e/h SGB V), such as the development of a strategy for the value dossier and management of dossier creation
Proof of Concept
Definition of the prerequisites for marketability in a 'proof of concept' approach, possibly accompanied by support of further development of the business model
Supportive guidance or lead of negotiation
OPS /NUB apllication
Strategic guidance as well as operative support fo
Market mobilization via landscaping the various participants and the development of an individual action and communication plan