[A21-140] Pitolisant (sleep apnoea) - Benefit assessment according to §35a Social Code Book V
Last updated 15.03.2022
Project no.: A21-140
Commission: Commission awarded on 01.11.2021 by the Federal Joint Committee (G-BA).
Report type: Dossier assessment
Status: Commission completed
Department/Division: Drug Assessment
Topic: Head and nerves
Improvement of wakefulness and reduction of excessive daytime sleepiness in adult patients with obstructive sleep apnoea (OSA) whose excessive daytime sleepiness has not been satisfactorily treated by, or who have not tolerated, primary OSA therapy, such as continuous positive airway pressure (CPAP)
Added benefit not proven
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.
The current version 1.1 of the dossier assessment replaces version 1.0 published on 2022-02-01.