The G-BA has now completed its benefit assessment of the CAR-T therapy, Tecartus, which is indicated for the treatment of mantle cell lymphoma.
Because Tecartus was given an orphan drug designation by the EMA, the additional benefit is automatically deemed proven. This means the G-BA does not define the certainty level. The extent of this additional benefit was seen as not-quantifiable since the supporting studies are not conclusive yet.
The G-BA has previously assessed two other CAR-T treatments, Kymriah and Yescarta. Consistently, the additional benefit was proven, but not quantifiable.
For all three CAR-T therapies, the G-BA resolution lists strict requirements on the quality standards. These need to be met in order for the CAR-Ts to be used and reimbursed.
The full G-BA assessment of Tecartus can be found here (in German only). The English translation is expected in September 2021.