We received a question from someone working on the development of a new cell therapy in an academic setting and who would like to prepare early for furture reimbursement. Is it possible to ask for advice at the HealthCare Institute (ZIN), when would be a suitable moment for such an advice and can someone give me advice or lessons learned how to prepare for such an advice application?
Hi Rosa,
Yes, in the current national assessment procedure, it is definitely possible to ask ZIN for advice when preparing for the future reimbursement of a new cell therapy. ZIN actually encourages early advice requests, especially for ATMPs like cell therapies.
The best time to seek advice is early on, ideally before submitting your reimbursement application. This allows you to identify potential issues and align your data with ZIN’s requirements. You’ll need three key parts: the Pharmaco-economic Analysis, Budget Impact Analysis, and Pharmacotherapeutics. ZIN has specific requirements, which you can find here. More info about the procedure can be found here.
Note: From 2025 onward, the clinical assessment for ATMPs will be handled at the European level through the Joint Clinical Assessment (JCA) process. You can also seek feedback through early dialogues (Joint Scientific Consultations) as part of the JCA process. These dialogues will help ensure your clinical studies are designed to meet both European and ZIN requirements. While the national consultations for clinical assessment may be replaced by these early dialogues, the Pharmaco-economic and Budget Impact discussions will remain at the national level.