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RPDC concept

Concept for routine practice data collection for etranacogene dezaparvovec acc. to the Law for More Safety in the Supply of Medicines (GSAV)

Status
Status: Commission completed
Project no.
A22-83
Last updated

Report documents

  1. Extract of the RPDC concept

    Concept for routine practice data collection for etranacogene dezaparvovec acc. to the Law for More Safety in the Supply of Medicines (GSAV)

    published on
    Document type
    PDF document, 276 kB, DE, not accessible
    Download file : Extract of the RPDC concept (PDF document, 276 kB, DE, not accessible)

  2. RPDC concept

    Concept for routine practice data collection for etranacogene dezaparvovec acc. to the Law for More Safety in the Supply of Medicines (GSAV)

    published on
    Document type
    PDF document, 980 kB, DE, not accessible
    Download file : RPDC concept (PDF document, 980 kB, DE, not accessible)

Additional information

Federal Joint Committee (G-BA)

2026-07-02 A G-BA decision was published.
G-BA documents on this decision (German version)

Project details

Project no.
A22-83
Commission
Commission awarded on 04.08.2022 by the Federal Joint Committee (GBA).
Report type
RPDC concept
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 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.

The current version 1.1 of the RPDC concept replaces version 1.0 published on 2023-05-17.

Connected Projects

  1. Rapid report

    Systematic search for registries in the therapeutic indication haemophilia B (congenital factor IX deficiency)

    Project no.
    I22-04
    Last updated

    Status: Commission completed

  2. Addendum

    Etranacogene dezaparvovec (haemophilia B): Review of the study protocol (Version 4.0) and the statistical analysis plan (Version 4.0) – Fourth addendum to Project A22-83 (RPDC concept)

    Project no.
    A26-21
    Last updated

    Status: Commission completed

  3. Addendum

    Routine practice data collection for etranacogene dezaparvovec (haemophilia B): Review of the study protocol (Version 3.0) and statistical analysis plan (Version 3.0) – Third addendum to Commission A22-83

    Project no.
    A24-38
    Last updated

    Status: Commission completed

  4. Addendum

    Routine practice data collection for etranacogene dezaparvovec (haemophilia B) acc. to the Law for More Safety in the Supply of Medicines (GSAV): Evaluation of the study protocol (Version 1.0) and the statistical analysis plan (Version 1.0) – Second addend

    Project no.
    A23-99
    Last updated

    Status: Commission completed

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