Most ATMPs are considered hospital products in Germany so hospital reimbursement must be secured prior to launch. This can be done either through “NUB applications”, ie applications for temporary funding for new hospital products not yet funded by the DRG payment system that covers in-patient treatment, or through single patient applications for reimbursement if no negotiated NUB funding is available at the time of launch. It is critical to secure adequate hospital reimbursement; this is just as important as a successful AMNOG outcome. ATMP market access in Germany is not just about the AMNOG, but rather about NUB payments, single patient requests, and input from payers and the Medical Review Board of the Statutory Health Insurance Funds (the MDK), which advises health insurers. NUB applications are to be filed by the individual hospitals by 31 October each year to secure additional reimbursement for hospitals on top of DRG payments. Hospitals will not purchase medicines if, as often happens, the DRG system does not cover their cost. This is why additional funding pathways such as NUB are essential for the uptake of cell and gene therapies in German hospitals.

Market Access Lessons For Cell And Gene Therapies In Germany

Companies Can Learn From Bluebird Bio’s Failed Zynteglo Pricing Deal

More from Europe

More from Geography