[A22-136] Review of the study protocol and statistical analysis plan on routine practice data collection for brexucabtagene autoleucel acc. to the Law for More Safety in the Supply of Medicines (GSAV) – Addendum to commission A21-130

Last updated 12.05.2023

Project no.:

Commission awarded on 22.12.2022 by the Federal Joint Committee (G-BA).

Report type:

Commission completed

Drug Assessment

Application field:


Routine practice data collection (RPDC): Review of the study protocol and statistical analysis plan

In the case of new drugs that have entered the health care system via a special marketing authorization or as a drug for the treatment of a rare disease, the study data at the time of marketing authorization are usually not very informative for the early benefit assessment. As in the present case, the G-BA can require the pharmaceutical company to collect routine practice data, including the associated analysis, for the benefit assessment. The pharmaceutical company has to submit a study protocol and a statistical analysis plan for the RPDC. IQWiG reviews these documents on behalf of the G-BA.

Federal Joint Committee (G-BA)

2023-05-12 A G-BA decision was published.
G-BA documents on this decision


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