One thing is common to all innovative products: A well-structured, professional market entry is essential to commercial success!
In each country there are different reimbursement scenarios and special regulatory requirements to take into account for the market entry strategy. We guide you through the complete launch process with many years of experience behind us within the German-speaking/European medical market.
Take advantage of our expertise and achieve success for your innovation with an optimal start into the German market.
A successful launch of innovative medical devices in Germany initially involves a detailed analysis of potential reimbursement. How will my innovation get reimbursed? What aspects should I pay attention to? How shall I proceed?
We offer you support on all these issues and evaluate the reimbursement of your product in the current Diagnosis-Related-Groups system (DRG). Moreover we investigate the potential of additional funding based on the regulations of the "Neue Untersuchungs- und Behandlungsmethoden" (NUB) (New Examination and Treatment Methods).
If your product does not fall within NUB regulations, we investigate alternative financing possibilities for you.
Please feel free to contact us for more details.
How many potential patients can benefit from your innovation in Germany?
We analyze how many patients could be treated (market volume) and we research which hospitals/clinicians these patients could be treated by (market distribution). This analysis is essential for your first steps into the market as you will need competent clinicians who will use your product as well as hospitals which will ensure the long-term development of reimbursement in the German DRG system.
When it comes to the proper pricing strategy for your product, a number of issues need to be addressed. Which price is appropriate for market entry? Can models such as 'value-added pricing' be transferred to the German market? How do the relevant authorities rate the price of your product?
We thoroughly research the reimbursement system in order to identify the price ranges in which your product can be sold in Germany. The price range is the basis for all subsequent application processes and your sales planning.
The Institute for Quality and Efficiency in Health Care (IQWiG) can be commissioned by the Federal Joint Committee (G-BA) to consider whether the price of drugs is in reasonable proportion to their therapeutic benefits. Recently a similar process for medical devices has been applied.
We examine whether your clinical data stands up to a cost-benefit analysis by the G-BA. In cases where your clinical data does not stand up to the analysis, we make suggestions for your future study designs.
Application / Regulatory Support
We support you throughout the application processes which will secure your funding until the costs of your product has been incorporated into the reimbursement system:
- Application for an individual German procedure classification code (OPS) or diagnostic code (ICD) at DIMDI
- Application for NUB payment at InEK
- Support for the cost-benefit assessment by the G-BA
- Application for a DRG modification or ZE payment at InEK
- Support in applying for the prescription of digital health applications (DiGA) at BfArM
OPS - Operationen- und Prozedurenschlüssel - German Procedure Classification Code
ICD – International Classification of Diseases
DIMDI – Deutsches Institut für Medizinsche Dokumentation und Information - German Institute of Medical Documentation and Information
NUB - Neue Untersuchungs- und Behandlungsmethoden - New Examination and Treatment Method German
InEK - Institut für das Entgeltsystem im Krankenhaus - Institute of Reimbursement in Hospitals
G-BA – Gemeinsamer Bundesausschuss - Federal Joint Committee
DRG – Diagnostic-related Groups
ZE – Zusatzentgelt – Extra Payment on top of DRG
BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte - The Federal Institute for Drugs and Medical Devices
Clinical examinations, findings and treatments have to be documented with the correct diagnostic codes of the ICD and the procedures codes of OPS for the successful application of innovations in the hospital.
inspiring-health compiles a coding guide for your innovation for the reimbursement-relevant documentation.
Our coding guides are suitable for physicians, coding assistants and medical controllers.
We use the coding guide additionally as a tool to present the innovative product to clinicians and hospital administrators. It can also be used for sales purposes.