RPDC concept
Concept for routine practice data collection – Odronextamab (relapsed or refractory DLBCL)
Report documents
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Extract of the RPDC concept
Concept for routine practice data collection – Odronextamab (relapsed or refractory DLBCL)
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RPDC concept
Concept for routine practice data collection – Odronextamab (relapsed or refractory DLBCL)
Additional information
Federal Joint Committee (G-BA)
2025-07-17 A G-BA decision was published.
G-BA documents on this decision (German version)
Project details
- Project no.
- A24-18
- Commission
- Commission awarded on 01.02.2024 by the Federal Joint Committee (GBA).
- Report type
- RPDC concept
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Cancer
- Note
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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.
- DOI
https://dx.doi.org/10.60584/A24-18
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Addendum
Routine practice data collection for odronextamab (DLBCL) - First addendum to Project A24-18
Status: Commission completed