[A22-20] Concept for routine practice data collection for valoctocogene roxaparvovec acc. to the Law for More Safety in the Supply of Medicines (GSAV)

Last updated 21.09.2023

Project no.:
A22-20

Commission:
Commission awarded on 02.03.2022 by the Federal Joint Committee (G-BA).

Report type:
Rapid report

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Haematology

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 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.

Federal Joint Committee (G-BA)

2023-09-21 A G-BA decision was published.

G-BA documents on this decision

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