The National Institute for Health and Care Excellence (NICE) has released an Appraisal Consultation Document (ACD) with draft guidance not recommending Nexavar® (sorafenib) for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have failed or are unsuitable for surgical or loco-regional therapies.1
HCC is the most common form of liver cancer and is responsible for approximately 70-85 % of the total primary liver cancer burden worldwide.2 Liver cancer is the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.3 In England, there are nearly 4500 new cases of liver cancer diagnosed each year.4
Dr Alexander Moscho, CEO Bayer UK/Ireland said, “We are disappointed with this draft guidance from NICE. Nexavar is the only licenced systemic treatment option in advanced HCC and there are clear disparities across the UK as patients in Scotland and Wales already have access to this important treatment. This approach will cause a delay in providing English patients and their physician long-term access.”
“At Bayer, we are dedicated to helping patients and their physicians by developing innovative treatment options, particularly in hard to treat cancers, where there remains a significant unmet need. We will continue to work with NICE and hope that a positive NICE appraisal will be granted and provide long-term funding in England for Nexavar.”
Sorafenib is one of the first medicines to be reviewed under the new Cancer Drugs Fund and NICE reconsideration process. Bayer will provide the additional data that has now been requested and would have done so earlier if the new process had not suggested it wasn’t required.
HCC is recognised as among the most chemo-resistant tumour types,5 and after 35 years of research sorafenib is the only licenced systemic treatment shown to improve overall survival in patients with advanced HCC.6
Sorafenib is a multikinase inhibitor with both anti-proliferative and anti-angiogenic properties.5 In Europe, it is licenced for the treatment of hepatocellular carcinoma; for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy; and for progressive, locally advanced or metastatic differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma refractory to radioactive iodine.7
In a pivotal phase III, placebo-controlled study of 602 patients with advanced hepatocellular carcinoma, median overall survival and the time to radiologic progression were nearly 3 months (2.8months) longer for patients treated with sorafenib than for those given placebo. The most frequent adverse events in the sorafenib group were diarrhoea, weight loss, hand-foot skin reaction and hypophosphataemia.6
- National Institute for Health and Care Excellence. Sorafenib for treating advanced hepatocellular carcinoma. Available at: https://www.nice.org.uk Last accessed August 2016
- Jemal A, Bray F, Center M, et. al. Global Cancer Statistics. CA Cancer J Clin. 2011;61:69–90.
- Verslype C, Rosmorduc O, Rougier P. Hepatocellular carcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012; 23 Suppl 7:vii41-vii48.
- Cancer Research UK.Liver Cancer Incidence Statistics. Available at http://www.cancerresearchuk.org/health-professional/cancer-statistics/st… Last accessed August 2016
- Vishwanath Ingle P, Zakiah Samsudin S, Qi Chan P. Development and novel therapeutics in hepatocellular carcinoma: a review. Therapeutics and Clinical Risk Management. 2016:12 445–455 Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4801152/pdf/tcrm-12-445.pdf Last accessed August 2016
- Llovet JM, Ricci S, Mazzaferro V et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378-90
- Nexavar Summary of Product Characteristics. November 2014. Available at www.medicines.org.uk/emc/ Last accessed August 2016