IQWiG Tasked by G-BA to Collect Application-Related Data on CAR-T Therapies

BERLIN, Germany – The Federal Joint Committee (G-BA) has tasked the Institute for Quality and Efficiency in Health Care (IQWiG) to come up with new ways to collect application-related data for new drugs, specifically CAR-T cell therapies.

Post-launch data collection in Germany has always been for one drug, not several new products.

In February, G-BA asked Novartis to gather data on the use of spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec) in clinical practice, in order to evaluate it for additional benefit assessment. Further, G-BA wanted Novartis to plan and implement a corresponding registry study to help close evidence gaps.

Given the uncertainty regarding the long-term use of such products, the collection of “care-related” data allows for the creation of a better database which can be used to assess the additional benefit of these products, according to certain criteria.

IQWiG will develop its own concept for collecting and evaluating data for these drugs. To start, IQWiG is developing a scientific concept for CAR-T cell therapies for the treatment of hemo-oncological diseases (including leukemia), which will be compared to existing therapy alternatives.

Its first concept should be ready in six months, said G-BA.