[G16-02] Daratumumab - Assessment according to §35a (para. 1., sentence 10) Social Code Book V

Last updated 01.12.2016

Project no.:

Commission awarded on 26.05.2016 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Health Economics

Application field:


In accordance with § 35a (para. 1, sentence 10) Social Code Book V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. For the Daratumumab report commissioned by the Federal Joint Committee (G-BA), IQWiG therefore solely assesses the information on patient numbers and costs in the pharmaceutical company's dossier.
After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. The resolution on the extent of added benefit is passed by the G-BA after the hearing. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA Website.

Federal Joint Committee (G-BA)

2016-12-01 A G-BA decision was published.

G-BA documents on this decision


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