[A21-54] Acalabrutinib (pretreated chronic lymphocytic leukaemia) - Addendum to Commission A20-105
Last updated 05.08.2021
Project no.:
A21-54
Commission:
Commission awarded on 27.04.2021 by the Federal Joint Committee (G-BA).
Report type:
Addendum
Status:
Commission completed
Department/Division:
Drug Assessment
Application field:
Cancer
Indication:
Adult patients with previously treated chronic lymphocytic leukaemia (CLL)
Result of dossier assessment:
Changed after addendum:
- Patients after pretreatment who have no 17p deletion or TP53 mutation and for whom chemo-immunotherapy is indicated: added benefit not proven.
- Patients after one prior therapy who have 17p deletion or TP53 mutation or for whom chemo-immunotherapy is not indicated for other reasons: hint of major added benefit.
- Patients after at least 2 pretreatments: 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 |
|---|---|---|
| A20-105 | Acalabrutinib (chronic lymphocytic leukaemia; pretreated) - Benefit assessment according to §35a Social Code Book V | Commission completed |
Federal Joint Committee (G-BA)
2021-08-05: A G-BA decision was published.