Givosiran (acute hepatic porphyria) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

Report documents

1. Dossier assessment

   Givosiran (acute hepatic porphyria) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V

   published on

   15.07.2020

   Document type

   PDF document, 200 kB, DE, not accessible

   Download file : Dossier assessment (PDF document, 200 kB, DE, not accessible)

Project details

Project no.

G20-07

Commission

Commission awarded on 15.04.2020 by the Federal Joint Committee (GBA).

Report type

Dossier assessment

Status

Commission completed

Department/Division

Health Economics

Topic

Digestion, metabolism and hormones

Note

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 Givosiran 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.