[A20-07] Trastuzumab emtansine (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 15.04.2020

Project no.:
A20-07

Commission:
Commission awarded on 14.01.2020 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Adults with HER2-positive early breast cancer who have residual disease, in the breast and/or lymph nodes, after preoperative systemic treatment including anti-HER2 treatment

Result of dossier assessment:

Negative effects in morbidity, health-related quality of life and side effects do not completely call into question the positive effect in recurrence; indication of minor added benefit

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.

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