1.1 Regorafenib is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib, only if:
they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and
the company provides it according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with regorafenib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Advanced unresectable hepatocellular carcinoma is mostly treated with sorafenib in the NHS. For people who cannot tolerate sorafenib, or whose disease progresses on sorafenib, the only current option is best supportive care. Regorafenib is a possible treatment option after sorafenib instead of best supportive care.
Clinical trial evidence comes from people who have advanced hepatocellular carcinoma that has been treated with sorafenib, and who have an ECOG performance status of 0 or 1 and Child–Pugh grade A liver impairment. This shows that people having regorafenib live longer than people having best supportive care. However, the trial does not include people who cannot tolerate sorafenib, or who have more severe liver disease or a poorer performance status. So it can't be assumed that these people would get the same benefits from regorafenib as the people in the trial.
Regorafenib meets NICE's criteria to be considered a life-extending treatment at the end of life. The most plausible cost-effectiveness estimates are within the range that NICE normally considers an acceptable use of NHS resources for end-of-life treatments. Therefore it is recommended for people with hepatocellular carcinoma who have had sorafenib, and have an ECOG performance status of 0 or 1 and Child–Pugh grade A liver impairment.