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Dossier assessment

Olaparib (prostate cancer) - Benefit assessment according to § 35a SGB V

Status
Status: Commission completed
Project no.
A23-03
Last updated

Report documents

  1. Extract of dossier assessment

    Olaparib (prostate cancer) - Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF document, 838 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 838 kB, EN, not accessible)

  2. Dossier assessment

    Olaparib (prostate cancer) - Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF document, 2 MB, DE, not accessible
    Download file : Dossier assessment (PDF document, 2 MB, DE, not accessible)

Dossier assessment

Indication:

Adults with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated

Result of dossier assessment:
  • Patients with treatment-naive mCRPC < 65 years: hint of minor added benefit
  • Patients with treatment-naive mCRPC ≥ 65 years: hint of lesser benefit
  • Patients with pretreated mCRPC: added benefit not proven

Press releases

Olaparib in metastatic prostate cancer: added benefit for certain patients

There is a benefit for younger treatment-naive patients. No relevant data were submitted for pretreated patients.
Press release

Additional information

Federal Joint Committee (G-BA)

2023-07-06 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A23-03
Commission
Commission awarded on 16.01.2023 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 (GBA) 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 GBA website.

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  11. Addendum

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