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Regorafenib for previously treated advanced hepatocellular carcinoma - NICE TAG TA514

1.1 Regorafenib is not recommended for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib.

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

In the NHS, advanced unresectable hepatocellular carcinoma is mostly treated with sorafenib. For people who cannot tolerate sorafenib, or whose disease progresses with sorafenib, the only current option is best supportive care. Regorafenib is a possible treatment option after sorafenib instead of best supportive care, in line with its marketing authorisation.

Clinical trial evidence in people with advanced hepatocellular carcinoma who have already had sorafenib, have an Eastern Cooperative Oncology Group (ECOG) performance status score of either 0 or 1, and Child‑Pugh grade A liver impairment shows that people having regorafenib live longer than people having best supportive care. However, the survival benefit with regorafenib is unclear in people who cannot tolerate sorafenib, have a poorer ECOG performance status or more severe liver disease. These people were not included in the trial so it is uncertain whether the results of the trial would translate into similar benefits in the NHS.

The company responded to the committee's preferred assumptions after consultation and submitted a further model incorporating these assumptions for overall survival extrapolation, full dose and pooled resource use surveys.

Regorafenib meets NICE's criteria to be considered a life-extending treatment at the end of life. The most plausible cost-effectiveness estimates are higher than those NICE normally considers an acceptable use of NHS resources for end-of-life treatments. Therefore regorafenib cannot be recommended for routine use in the NHS.

Regorafenib is not recommended through the Cancer Drugs Fund because the uncertainties in the clinical and cost effectiveness cannot be resolved by data collection in the Cancer Drugs Fund, and regorafenib does not have plausible potential to be cost effective.



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