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HCC Guidelines
Nexavar® (sorafenib) then Stivarga® (regorafenib) – the only systemic treatment sequence to be recommended by NICE and accepted for use by the SMC
Nexavar then Stivarga is recommended for patients with advanced or metastatic HCC who have tolerated and progressed on Nexavar.
NICE Guidance TA474
- 1.1 Nexavar is recommended as an option for treating advanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment, only if the company provides Nexavar within the agreed commercial access arrangement.
- 1.2 This recommendation is not intended to affect treatment with Nexavar 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.
NICE Guidance TA555
- 1.1 Stivarga is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had Nexavar, 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
(http://www.nice.org.uk/guidance/ta555). - 1.2 This recommendation is not intended to affect treatment with Stivarga 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.
Scottish Medicines Consortium advice
- ADVICE: following a full submission assessed under the end of life process Stivarga (regorafenib) is accepted for use within NHS Scotland.
- Indication under review: as monotherapy for the treatment of adult patients with hepatocellular carcinoma who have been previously treated with Nexavar.
- In a randomised, double-blind, Phase III study in patients with hepatocellular cancer that had progressed on sorafenib [Nexavar] treatment, regorafenib [Stivarga] significantly improved overall survival (p<0.0001) compared with placebo on a background of best supportive care.
- This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of regorafenib [Stivarga]. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.
NCCN Clinical Practice Guidelines in Oncology, EASL HCC clinical practice guidelines, and BCLC staging support a systemic treatment plan of Nexavar then Stivarga for unresectable HCC
Modified BCLC staging system
Abbreviations: BCLC: Barcelona Clinic Liver Cancer; EASL: European Association for the Study of the Liver; NCCN: National Comprehensive Cancer Network; NICE: National Institute for Health and Care Excellence; SMC: Scottish Medicines Consortium.
Find out more about how Nexavar then Stivarga can help you potentially optimise the extended overall survival (vs Nexavar then placebo) of your patients
Survival benefit in HCC
Managing adverse events
PP-NEX-GB-0217 | February 2024
- Referencesexpand_more
- 1National Institute for Health and Care Excellence (NICE) guidance. Sorafenib for treating advanced hepatocellular carcinoma. Available at: https://www.nice.org.uk/guidance/ta474 (Last Accessed February 2024)
- 2National Institute for Health and Care Excellence (NICE) guidance. Regorafenib for previously treated advanced hepatocellular carcinoma. Available at: https://www.nice.org.uk/guidance/ta555 (Last Accessed February 2024)
- 3Scottish Medicines Consortium. 2018. Advice 1316/18. Available at: https://www.scottishmedicines.org.uk/medicines-advice/regorafenib-stivarga-fullsubmission (Last Accessed February 2024)
- 4NCCN Clinical Practice Guidelines in Oncology for Hepatobiliary Cancers. 2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf (Last Accessed February 2024)
- 5EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol 2018;69(1):182-236.
- 6Forner A et al. Lancet 2018;391(10127):1301-1314.
- 7Stivarga (regorafenib) Summary of Product Charateristics. Available at: https://www.medicines.org.uk/emc/product/1263 (Last Accessed February 2024)