[A19-59] Ravulizumab - Benefit assessment according to §35a Social Code Book V

Last updated 04.11.2019

Project no.:
A19-59

Commission:
Commission awarded on 01.08.2019 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Haematology

Indication:

Adults with paroxysmal nocturnal haemoglobinuria (PNH)

Result of dossier assessment:

Added benefit neither proven for patients with haemolysis and at least one clinical symptom indicative of high disease activity nor for clinically stable patients after at least 6 months of eculizumab treatment

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.

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