[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
Application field:
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.
| Project no. | Title | Status |
|---|---|---|
| A22-108 | Relugolix (prostate cancer) – Benefit assessment acc. to § 35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2023-04-06 A G-BA decision was published.