[G17-01] Obeticholic acid (primary biliary cholangitis) – Assessment according to § 35a (para. 1, sentence 10) Social Code Book V

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 Obeticholic acid 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.