News Release 

German health insurance regulator directs centres to report commercial CAR-T treatments to EBMT

European Society for Blood and Marrow Transplantation

Science Business Announcement

On 17 September 2020, the Gemeinsame Bundesausschuss (G-BA) published its directions on the treatment of German patients with CAR T-cell therapies. According to the decision, beside structural and qualification requirements, the treating facilities must report patients to the German Register for Stem Cell Transplantation (DRST), the Pediatric Register for Stem Cell Transplantation (PRST) or the European Society for Blood and Marrow Transplantation (EBMT) Registry. Reporting data is a condition for reimbursement of CAR T cell costs to hospitals treating patients with these new therapies.

The Gemeinsame Bundesausschuss (G-BA) or Federal Joint Committee in English is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. It issues directives for the benefit catalogue of the statutory health insurance funds (GKV) for more than 73 million insured persons and thus specifies which services in medical care are reimbursed by the GKV. The G-BA is subject to the statutory supervision of the Federal Ministry of Health (https://www.g-ba.de/english/)

The EBMT welcomes the G-BA decision as an important step forward towards centrally registering all European patients treated with CAR T-cell therapies. EBMT encourages other authorities to engage with the principal European cell therapy registry, as qualified by the European Medicines Agency (https://www.ema.europa.eu/en/documents/scientific-guideline/qualification-opinion-cellular-therapy-module-european-society-blood-marrow-transplantation-ebmt_en.pdf), offering a single source of comprehensive data to support benefit-risk monitoring of these products, regulatory decision making and collaborative studies. EBMT is engaged in continuous dialogue with all stakeholders that contribute to ongoing developments in the cellular therapy field through the GoCART initiative.

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