WIREDGOV

NICE has been unable to recommend sorafenib (Nexavar, Bayer) for treating advanced hepatocellular carcinoma (HCC) because its high cost could not be justified by its marginal benefit.

HCC is 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. Normal life expectancy for these patients is less than 24 months. The trial evidence seen by NICE’s independent advisory committee showed that sorafenib increases survival by an average further 2.8 months, but at a cost of £27,000 per patient. Half of the patients who gained some benefit received less than this amount of additional life.

In final guidance published today (26 May, 2010) NICE has not recommended sorafenib for treating advanced HCC in patients for whom surgery or therapies in the region the cancer arose have failed or are not suitable.

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 changed our approach to appraising high cost treatments which can potentially 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 is simply too high to justify using NHS money which could be spent on better value, more effective cancer treatments."

The appeal against the Final Appraisal Determination from Bayer was not upheld.

A pdf version of this press release is available.