Concept for routine practice data collection - autologous anti-CD19-transduced CD3+ cells

Report documents

1. Extract of the rapid report

   Concept for routine practice data collection - autologous anti-CD19-transduced CD3+ cells

   published on

   09.08.2022

   Document type

   PDF document, 256 kB, DE, not accessible

   Download file : Extract of the rapid report (PDF document, 256 kB, DE, not accessible)
2. Rapid Report

   Concept for routine practice data collection - autologous anti-CD19-transduced CD3+ cells

   published on

   09.08.2022

   Document type

   PDF document, 916 kB, DE, not accessible

   Download file : Rapid Report (PDF document, 916 kB, DE, not accessible)

Additional information

Project details

Project no.

A21-130

Commission

Commission awarded on 07.10.2021 by the Federal Joint Committee (GBA).

Report type

Rapid report

Status

Commission completed

Department/Division

Drug Assessment

Topic

Cancer

Note

Routine practice data collection (RPDC concept):

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. In these cases, according to the Law for More Safety in the Supply of Medicines (GSAV), the GBA can require the pharmaceutical company to collect routine practice data, including the associated analysis, for the benefit assessment. IQWiG prepares the concept for such a routine practice data collection on behalf of the GBA.

Connected Projects

1. Addendum

   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

   Project no.

   A22-136

   Last updated

   12.05.2023

   Status: Commission completed

2. Addendum

   Routine practice data collection for brexucabtagene autoleucel: Review of the study protocol (Version 2.0) and statistical analysis plan (Version 2.0) – Third Addendum to Commission A21-130

   Project no.

   A23-33

   Last updated

   25.07.2023

   Status: Commission completed

3. Addendum

   Routine practice data collection for brexucabtagene autoleucel acc. to the Law for More Safety in the Supply of Medicines (GSAV): Evaluation of the study protocol (Version 3.0) and the statistical analysis plan (Version 3.0) – Fourth addendum to Commission

   Project no.

   A23-89

   Last updated

   17.11.2023

   Status: Commission completed

4. Addendum

   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

   Project no.

   A25-36

   Last updated

   24.06.2025

   Status: Commission completed