[A18-59] Dabrafenib (melanoma) - Benefit assessment according to §35a Social Code Book V

Last updated 22.03.2019

Project no.:
A18-59

Commission:
Commission awarded on 24.09.2018 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Cancer

Indication/Intervention:

Adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection

Result of dossier assessment:

Advantage in overall survival and recurrence, disadvantages in side effects; indication of considerable 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.

02.01.2019

Melanoma: dabrafenib and trametinib have added benefit

The drug combination showed longer survival and fewer or later recurrences.

Current document

Accompanying information

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

Federal Joint Committee (G-BA)

2019-03-22 A G-BA decision was published.

G-BA documents on this decision

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