Dossier assessment

Radium-223 dichloride (mCRPC) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

Status
Status: Commission completed
Project no.
A19-32
Last updated

Report documents

  1. Extract of dossier assessment

    Radium-223 dichloride (mCRPC) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

    published on
    Document type
    PDF-Dokument, 184 kB, EN, PDF
  2. Dossier assessment

    Radium-223 dichloride (mCRPC) - Benefit assessment according to §35a Social Code Book V (new scientific findings)

    published on
    Document type
    PDF-Dokument, 334 kB, DE, PDF

Dossier assessment

Indication:

Adults with metastatic castration-resistant prostate cancer and symptomatic bone metastases (without visceral metastases) whose disease has progressed after several systemic treatments or for whom no other systemic treatment is suitable

Result of dossier assessment:

Added benefit is not proven due to a lack of suitable study data

Additional information

Federal Joint Committee (G-BA)

2019-10-17 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A19-32
Commission
Commission awarded on 03.04.2019 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Cancer
Note

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

Connected Projects

  1. Dossier assessment

    Radium-223-dichloride - Benefit assessment according to § 35a Social Code Book V (dossier assessment)

    Project no.
    A14-02
    Last updated

    Status: Commission completed

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