NICE rejects Nexavar – again

NICE has again proposed the refusal of NHS funding for Nexavar (sorafenib) for the treatment of advanced hepatocellular carcinoma (HCC) – a form of liver cancer.

Supporters of the drug have expressed their concern as they believe Nexavar is the only systemic treatment option that could extend the survival of these patients.

The treatment has demonstrated a 44% increase in survival for advanced HCC patients, compared to best supportive care alone, and is the first systemic drug for advanced HCC to show a significant survival benefit after 30 years of randomised comparative trials.

Dr Harpreet Wasan, Medical Oncologist, Hammersmith Hospital, Imperial College, London, said: “Other than sorafenib, every systemic treatment that has been evaluated in advanced HCC has failed to significantly extend survival. Today’s decision, unless reversed, puts us in a unique situation in cancer where we are left with nothing to offer advanced HCC patients apart from supportive and palliative care, thus denying them the life-preserving benefits of modern treatments.”

Dr Wasan explained that the ruling is also “painfully disheartening” for British oncologists, many of whom were involved in the trials for the drug and are now unable to prescribe it.

Alison Rogers, Chief Executive of the British Liver Trust, commented: “This is a very poor decision for patients with HCC in the UK. Liver cancer is a major concern for the Trust and the Trust calls for improvements throughout the liver cancer patient pathway, including better prevention, earlier diagnosis and access to curative and palliative treatments, together with the need for improved liver services as a whole.”

Manufacturer Bayer Schering Pharma has expressed its surprise that the drug has been rejected again, despite a proposed patient access scheme to cut the cost of treatment to the NHS. Nicole Farmer, Business Unit Head of Oncology, commented: “This proposal by NICE conflicts dramatically with the Government’s strategy to bring UK cancer outcomes in line with the rest of Europe (where Nexavar is already widely available in countries such as France, Germany, Spain, Italy, Romania, and Greece) and reaffirms why the UK currently sits at 14–15 out of 18 EU countries with regard to cancer survival.”

The preliminary decision has been published as an Appraisal Consultation Document (ACD), which is now open for further discussion before a final appraisal meeting.