National Institute for Health and Clinical Excellence (NICE)
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NICE appraisal of sorafenib for advanced hepatocellular carcinoma

The National Institute for Health and Clinical Excellence (NICE) is currently appraising the use of sorafenib for advanced hepatocellular carcinoma (HCC) in patients for whom surgery or therapies in the region the cancer arose have failed or are not suitable. In its latest draft guidance, published last week (19 November 2009), NICE does not recommend sorafenib.

In line with the NICE technology appraisals process this draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance

NICE has not yet issued final guidance to the NHS.

HCC is the most common type of primary liver cancer – a cancer that originates in the liver, not as the result of tumours spreading to the liver from other parts of the body. The only potentially curative treatment for HCC is surgery, but only a small proportion of patients will be eligible for this.

Andrew Dillon, Chief Executive of NICE said: “We were disappointed not to have  been able to recommend the use of  sorafenib, but after carefully considering all the evidence, including the proposed ‘patient access scheme’ in which the manufacturer offered to provide every fourth pack free, sorafenib does not provide enough benefit to patients to justify its high cost.

“We have recently changed our approach to appraising high cost treatments which can extend life for terminally ill patients. This has meant that more of them are now being recommended. We looked at sorafenib in just the same way but the price being asked by Bayer is simply too high to justify using NHS money which could be spent on better value cancer treatments.”

“The company, together with patient groups, professional associations and other consultees, now have 3 weeks to consider whether to appeal against our proposed guidance.”

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Subject to any appeals being received, guidance is expected in January 2010. The Final Appraisal Determination is available on the guidance page.

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