• Active Substance: Regorafenib
  • Name: Stivarga©
  • Therapeutic area: Hepatocellular carcinoma (HCC) 
  • Pharmaceutical company: Bayer Vital GmbH


Time table:

  • Publication of project plan: 10.07.2017
  • Publication of final assessment: 25.10.2017


Assessment information:

  • Title: Regorafenib (Stivarga©) indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib 
  • Author/Co-Author: HAS (France), INFARMED (Portugal)
  • Dedicated Reviewers: AAZ (Croatia), SNHTA (Swiss), FIMEA (Finland), LBI-HTA (Austria), NIPN (Hungary), AETSA (Spain), 
  • Information retrieval: IQWiG (Germany)
  • Observer: EOF (Greece), EKAPTY (Greece)

G-BA assessment not available
Reason: Regorafenib has been withdrawn from the German market prior to launch in the new indication (2016).