[A25-36] Routine practice data collection for brexucabtagene autoleucel (MCL): Review of the study protocol (Version 4.0) and statistical analysis plan (Version 4.0) – Sixth Addendum to Project A21-130
Last updated 24.06.2025
Project no.:
A25-36
Commission:
Commission awarded on 24.02.2025 by the Federal Joint Committee (G-BA).
Report type:
Addendum
Status:
Commission completed
Department/Division:
Drug Assessment
Topic:
Cancer
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.
https://doi.org/10.60584/A25-36
Project no. | Title | Status |
---|---|---|
A21-130 | Concept for routine practice data collection - autologous anti-CD19-transduced CD3+ cells | Commission completed |
Federal Joint Committee (G-BA)
2025-06-18 A G-BA decision was published.
G-BA documents on this decision (German version)