[G23-06] Pitolisant (narcolepsy, with or without cataplexy, children and adolescents, 6-17 years) – Assessment according to §35a (para. 1., sentence 11) Social Code Book V

Last updated 03.07.2023

Project no.:
G23-06

Commission:
Commission awarded on 04.04.2023 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Health Economics

Topic:
Head and nerves

Note:

In accordance with §35a (1) Sentence 11 Social Code Book (SGB) V, the added medical benefit of orphan drugs is deemed as proven by the fact that they have been approved. On behalf of 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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