[A19-06] Ribociclib (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 04.07.2019

Project no.:
A19-06

Commission:
Commission awarded on 14.01.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

Patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer

Result of dossier assessment:

Postmenopausal women: survival advantages, but also higher frequency of severe side effects. Overall: added benefit not proven. Pre- and perimenopausal women: indication of lesser benefit than appropriate comparator therapy for one group of patients; other groups: 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.

15.04.2019

Ribociclib in advanced breast cancer: survival advantages, accompanied by severe side effects

Overall, added benefit not proven

Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

Federal Joint Committee (G-BA)

2019-07-04 A G-BA decision was published.

G-BA documents on this decision

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