[G19-13] Volanesorsen (familial chylomicronaemia syndrome) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V
Last updated 15.11.2019
Project no.:
G19-13
Commission:
Commission awarded on 15.08.2019 by the Federal Joint Committee (G-BA).
Report type:
Dossier assessment
Status:
Commission completed
Department/Division:
Health Economics
Application field:
Digestion, metabolism and hormones
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 Volanesorsen 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.