[G19-07] Blinatumomab (ALL, paediatric patients) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

Last updated 15.05.2019

Project no.:

Commission awarded on 13.02.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Commission completed

Health Economics

Application field:


In accordance with § 35a (para. 1, sentence 11) 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 Blinatumomab 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.


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