[G18-13] Inotersen (hereditary transthyretin amyloidosis with polyneuropathy) - Assessment according to §35a (para. 1., sentence 11) Social Code Book V
|Commission:||Commission awarded on 2018-09-27 by the Federal Joint Committee (G-BA)|
|Current document:||Dossier assessment (German version) Further documents|
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 Inotersen 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.
|Contact address:||to the contact form|
|2019-01-02||Dossier assessment (German version)||140 kB|
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.