STIVARGA (regorafenib), tyrosine kinase inhibitor
Reason for request
High clinical benefit in the treatment of hepatocellular carcinoma in patients in good general condition (ECOG 0-1), with preserved liver function (Child-Pugh A) and who displayed good tolerance of their previous sorafenib treatment, along with minor clinical added value in the therapeutic strategy.
Insufficient clinical benefit to justify reimbursement in other clinical situations.
STIVARGA has been granted marketing authorisation for the treatment of adults with hepatocellular carcinoma (HCC) previously treated with sorafenib.
The available data, derived mainly from a phase III study conducted on a stringently selected population, show a modest gain in terms of overall survival (+2.8 months), with no robust data concerning quality-of-life relative to supportive care and at the expense of reduced safety.
This study excluded patients with a degraded general condition (ECOG>1), impaired liver function (Child-Pugh B or C) and those who did not tolerate their previous sorafenib treatment well.
Clinical Added Value