[A22-108] Relugolix (prostate cancer) – Benefit assessment acc. to § 35a Social Code Book V

Last updated 06.04.2023

Project no.:
A22-108

Commission:
Commission awarded on 17.10.2022 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Patients with hormone-sensitive prostate cancer

Result of dossier assessment:
  • Patients with advanced hormone-sensitive prostate cancer who are candidates for local therapy: added benefit not proven
  • Patients with advanced hormone-sensitive prostate cancer who are not candidates for local therapy: added benefit not proven
  • Patients with advanced hormone-sensitive prostate cancer and with PSA recurrence or clinical recurrence after primary local therapy: added benefit not proven
  • Patients with metastatic hormone-sensitive prostate cancer who are candidates for combination therapy: added benefit not proven
  • Patients with metastatic hormone-sensitive prostate cancer who are not candidates for combination therapy: added benefit not proven
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.

The current version 1.1 of the dossier assessment replaces version 1.0 published on 2023-01-16.

Federal Joint Committee (G-BA)

2023-04-06 A G-BA decision was published.

G-BA documents on this decision

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