Medtech

The path to reimbursement
Although there are numerous political efforts to unify and standardize reimbursement processes at a European level, the reimbursement of medical products is still solely based on national regulations. In comparison to pharmaceuticals, medical technologies have multiple ways of achieving reimbursement in Germany. However, they differ both largely in their contentual and formal requirements, as well as in their success and market potential.

To successfully master the market access process, companies in the medical technology and biotechnology sector are advised to ask themselves the following questions:

• How must I classify my product or software, and which strategic challenges await me during market access?
• What is the current care situation in Germany and how does my medical device fit into existing healthcare pathways?
• Which regulatory requirements are tied to the clinical application (e.g. in the outpatient sector in comparison to the inpatient sector), and which reimbursement options are suitable?
• Does my current clinical evidence meet the requirements of a benefit assessment procedure and what evidence is required to demonstrate a benefit?
• How can the potential benefits of my medical device be optimally emphasized in the clinical care reality?
• How does the selection of the reimbursement pathway and the current standard of care affect my pricing?

Target-oriented from the start
A key factor for achieving successful reimbursement is the development of a comprehensive market access strategy starting already in the product development phase. Therefore, knowledge of the regulatory requirements is paramount. How the reimbursement process is structured in detail also depends on the mode of action and the area of application, and eventually also on the defined risk class, which may facilitate or intensify the regulatory requirements. Apart from the chosen reimbursement pathway, a thorough understanding of the market and the care provision is crucial. Only those who know the specific supply path and the stakeholders involved can successfully market a product with a convincing value story that satisfies customer requirements. In order to be able to mobilize the market at an early stage and make use of market potentials, it is important to evaluate the different strategic options in detail with regard to the implementation potential and possible barriers in the market access process.

With experience and knowledge
SKC has extensive experience with reimbursement mechanisms, particulary in Germany, which is the largest market for medical devices in the EU. In addition, due to our longstanding years of activity in the health care sector, we know and understand the key regulatory institutions and are thus able to incorporate their perspective, 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: starting 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 individual services. Moreover, offer support in necessary negotiations with statutory health insurances or the statutory health insurance scheme and other cost bearers and actors in the health care system in terms of implementing the reimbursement strategy.