[G14-01] Macitentan - Assessment according to §35a (para. 1., sentence 10) Social Code Book V (dossier assessment)

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 Macitentan 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. 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.