Bayer’s Stivarga is not being recommended by NHS treatment cost regulators for certain patients with advanced unresectable hepatocellular carcinoma.

The National Institute for Health and Care Excellence has published an appraisal consultation document rejecting use of Stivarga (regorafenib) in adults who have had already had access to sorafenib.

Currently, for people who cannot tolerate sorafenib, or whose disease progresses on the drug, the only other option in the UK is best supportive care.

Stivarga is licensed in Europe as an option in these circumstances, but according to NICE’s appraisal committee, the survival benefit “is unclear in those who are intolerant of sorafenib, have more severe liver disease or a poorer performance status.”

Such patients were not included in the trial and therefore it is uncertain whether the data submitted are relevant to NHS clinical practice, the committee noted.

Furthermore, while the drug meets NICE’s criteria for end-of-life therapies, the most plausible estimates are higher than those normally considered an acceptable use of NHS resources.

The committee considered that the range of plausible incremental cost effectiveness ratios for Stivarga compared with best supportive care would be more than £50,000 and up to £74,559 per QALY gained, and thus outside of what is normally considered value for money.

Moreover, Stivarga is not recommended through the Cancer Drugs Fund “because it does not have plausible potential to be cost effective,” and the clinical uncertainties “ cannot be resolved by data collection in the CDF”, NICE noted.

The decision comes after the cost regulator published final draft guidance last month approving routine for the drug to treat patients with gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.