[A23-13] Relugolix (prostate cancer) – Addendum to Commission A22-108

Last updated 06.04.2023

Project no.:
A23-13

Commission:
Commission awarded on 20.02.2023 by the Federal Joint Committee (G-BA).

Report type:
Addendum

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Cancer

Indication:

Patients with hormone-sensitive prostate cancer

Result of dossier assessment:

Unchanged after addendum:

  • 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:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

Federal Joint Committee (G-BA)

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

G-BA documents on this decision

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