1 Recommendations

1.1 Lenvatinib is recommended as an option for untreated, advanced, unresectable hepatocellular carcinoma in adults, 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 lenvatinib 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 treated with sorafenib, but some people cannot tolerate it because of side effects.

Clinical trial evidence shows that lenvatinib slows disease progression and causes more tumours to shrink than sorafenib. The evidence also shows that people having lenvatinib live for about as long as those having sorafenib. Lenvatinib has different side effects to sorafenib and this would benefit some people.

Using the most plausible assumptions and including the commercial arrangement, the cost-effectiveness estimates for lenvatinib compared with sorafenib are within the range NICE normally considers acceptable. Therefore, lenvatinib is recommended for untreated, advanced, unresectable hepatocellular carcinoma in adults with Child–Pugh grade A liver impairment and an ECOG performance status of 0 or 1.

  • National Institute for Health and Care Excellence (NICE)