In Germany, innovations for the healthcare sector are often introduced to the market via the inpatient sector, as the requirements there are lower. The decisive factor is whether the new procedure is a high-risk medical device or not. For high-risk medical devices, the Federal Joint Committee (G-BA) reviews the available evidence and, if necessary, initiates a trial study together with the manufacturer (temporary reimbursement while evidence generation).
In contrast, the Federal Office for Drugs and Medical Devices (BfArM) is responsible for digital health applications (DiGA). Similar to medical devices, it is also possible to conduct a trial study here if there is not yet enough evidence.
Due to the evidence requirements, it is imperative to include study planning in the market access strategy. In order to achieve a certain price for the product, a third player has to be involved. The Institute for Hospital Remuneration Systems (InEK) plays a special role in the remuneration of so-called new examination and treatment methods (NUB).
This new meeting, proposed jointly by the Medtech and Diagnostics Committee of France Biotech, its Market Access Working Group and Inspiring Health, will address all these topics and provide the most relevant answers.
Reception from 10h30
11h00 – Presentation : Market Access Germany
11h30 – Workshops
Workshop 1 – Implants and invasive disposables (high risk and non-high risk)
- Different reimbursement pathways for high risk and non-high risk devices
- Eligibility criteria
- Process, timelines and evidence requirements
Workshop 2 – Digital Health Application (DiGA)
- What is a DiGA?
- Different options in reimbursement process
- Process and timelines
- Evidence and IT requirements
12h15 – Wrap-up all together
12h45 – Conclusion
13h00 – Buffet with Experts
*seminar in english only