NICE Proposes To Refuse Nexavar(R) (Sorafenib) For Liver Cancer Patients

Main Category: Cancer / Oncology
Also Included In: Liver Disease / Hepatitis;  Regulatory Affairs / Drug Approvals
Article Date: 10 Sep 2009 - 3:00 PDT

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Today, in an alarming move, the National Institute for Health and Clinical Excellence (NICE) has, once again, proposed to deny Nexavar® (sorafenib) for the treatment of advanced hepatocellular carcinoma (HCC) - a form of liver cancer. Nexavar® is the only systemic treatment option that could potentially extend the survival of these patients.

Cases of liver cancer have almost tripled over the last three decades according to figures recently published by Cancer Research UK1. In 1975 there were 865 cases of primary liver cancer and in 2006 that had risen to 3,108 in the UK1. HCC accounts for 80-90% of these primary liver cancers2.

Nexavar® has demonstrated a 44% increase in survival for advanced HCC patients, compared to best supportive care alone3. Nexavar® 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. This is a devastating blow to patients and their families who will be robbed of precious time together. It is also painfully disheartening for British oncologists, many of whom were involved in the trials for this drug as they, effectively, will not be able to prescribe it."

Mr Graeme Poston, an eminent liver surgeon on behalf of the Hepatobiliary UK Group (HUG), President-Elect of the Association of Upper Gastrointestinal Surgeons (AUGIS) and former President of the British Association of Surgical Oncologists (BASO) said: "I am naturally disappointed that NICE appears to have not taken into account the views of leading healthcare professionals in the field. The Hepatobiliary UK Group of doctors who specialise in treatment of HCC recently launched national guidelines for the UK which clearly state that sorafenib is the standard of care for patients with advanced HCC for whom no potential curative option is available. With this decision, physicians in the UK will be unable to provide the best possible care for their HCC patients, even though sorafenib treatment is readily available to patients in other parts of the world.''

Alison Rogers, Chief Executive of the British Liver Trust comments: "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".

Nicole Farmer, Business Unit Head of Bayer Schering Pharma Oncology in the UK commented: "As a company, we have proposed an excellent patient access scheme for Nexavar®, unique to the UK, to enable patients in this country to benefit from this life-extending medicine. We thought we had satisfied NICE's criteria for how Nexavar® would be assessed - however, the 'goal posts' appeared to have moved. 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 survival4".

Glossary

Primary liver cancer: Primary liver cancer is where the cancer originates in the liver. Systemic therapy: Treatment using substances which travel through the bloodstream, reaching and affecting cells all over the body. Secondary Liver Cancer: Secondary liver cancer, where a tumour in another part of the body spreads to the liver, is relatively common, but cancers originating in the liver were relatively unusual until recently according to Cancer Research UK1

NICE HCC Decision

NICE have today issued a second ACD for Nexavar in advanced hepatocellular carcinoma. The ACD and evaluation report will be posted on the Institute's website on 9th September 2009. The Appraisal Committee will reconsider the ACD at a meeting on 14th October 2009.

About sorafenib for liver cancer

Sorafenib was licensed by the EMEA in October 2007. Sorafenib is licensed in the UK for the treatment of patients with hepatocellular carcinoma (HCC) the most common form of primary liver cancer who are unsuitable for loco-regional therapies. Sorafenib is the only licensed systemic therapy in the UK proven to significantly prolong survival for patients with advanced HCC versus best supportive care alone.

Sorafenib's differentiated mechanism

Sorafenib targets both the tumour cell and tumour vasculature. In preclinical studies, sorafenib has been shown to target kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases included Raf kinase, VEGFR-2, VEGFR-3, PDGFR-B, c-KIT, FLT-3 and RET5. Preclinical models have also demonstrated that the Raf/MEK/ERK pathway has a role in HCC6.

Source
Bayer Schering Pharma

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