[A23-67] Concept for routine practice data collection acc. to the Law for More Safety in the Supply of Medicines (GSAV) – exagamglogene autotemcel (beta-thalassaemia)
Last updated 01.02.2024
Project no.:
A23-67
Commission:
Commission awarded on 06.07.2023 by the Federal Joint Committee (G-BA).
Report type:
RPDC concept
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Haematology
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 G-BA 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 G-BA.
https://dx.doi.org/10.60584/A23-67
| Project no. | Title | Status |
|---|---|---|
| G23-07 | Exagamglogene autotemcel (transfusion-dependent β-thalassaemia) - Assessment according to §35a Social Code Book V | Commission completed |
| I23-03 | Exagamglogene (ß-thalassaemia in patients ≥ 12 years); assessment according to §35a Social Code Book V; search for disease registries | Commission completed |
Federal Joint Committee (G-BA)
2024-02-01 A G-BA decision was published.