[A18-72] Abemaciclib in combination with an aromatase inhibitor (breast cancer) - Benefit assessment according to §35a Social Code Book V

Last updated 02.05.2019

Project no.:
A18-72

Commission:
Commission awarded on 29.10.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication:

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

Result of dossier assessment:

Initial endocrine therapy in postmenopausal women: indication of lesser benefit in comparison with appropriate comparator therapy. Subsequent endocrine therapy and/or pre- or perimenopausal women: added benefit not proven due to a lack of study data.

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.

Accompanying information

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

Federal Joint Committee (G-BA)

2019-05-02 A G-BA decision was published.

G-BA documents on this decision

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