German medical insurance regulator directs centres to report industrial CAR-T treatments to EBMT


On 17 September 2020, the Gemeinsame Bundesausschuss (G-BA) released its instructions on the treatment of German clients with VEHICLE T-cell treatments. According to the choice, next to structural and credentials requirements, the dealing with centers need to report clients to the German Register for Stem Cell Transplant (DRST), the Pediatric Register for Stem Cell Transplant (PRST) or the European Society for Blood and Marrow Transplant (EBMT) Windows Registry. Reporting information is a condition for repayment of VEHICLE T cell expenses to healthcare facilities dealing with clients with these brand-new treatments.

The Gemeinsame Bundesausschuss (G-BA) or Federal Joint Committee in English is the greatest decision-making body of the joint self-government of doctors, dental professionals, healthcare facilities and medical insurance funds in Germany. It releases instructions for the advantage brochure of the statutory medical insurance funds (GKV) for more than 73 million guaranteed individuals and therefore defines which services in treatment are compensated by the GKV. The G-BA goes through the statutory guidance of the Federal Ministry of Health (https://www.g-ba.de/english/)

The EBMT invites the G-BA choice as a crucial advance towards centrally signing up all European clients treated with VEHICLE T-cell treatments. EBMT motivates other authorities to engage with the primary European cell treatment computer registry, as certified by the European Medicines Company (https://www.ema.europa.eu/en/documents/scientific-guideline/qualification-opinion-cellular-therapy-module-european-society-blood-marrow-transplantation-ebmt_en.pdf), using a single source of extensive information to support benefit-risk tracking of these items, regulative choice making and collective research studies. EBMT is participated in constant discussion with all stakeholders that add to continuous advancements in the cellular treatment field through the GoCART effort. .

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