NICE rules against liver cancer drug sorafenib

In collaboration with the Press Association

The National Institute for Health and Clinical Excellence (NICE) has ruled that sorafenib should not be made routinely available for patients with the most common form of primary liver cancer, advanced hepatocellular carcinoma (HCC).

The institute's appraisal committee reviewed research that has been conducted on the drug and concluded that it does not represent a cost-effective use of NHS resources.

The results of a large-scale clinical trial found that sorafenib is helpful for patients who have not benefited from surgery, or for whom surgery is not a suitable option.

At present, surgery is the only treatment that can actually cure HCC, but most patients are not eligible. Sorafenib can help extend the lives of people with HCC by many weeks, but it is not a cure.

Andrew Dillon, chief executive of NICE, insisted that the institute is disappointed not to have been able to recommend sorafenib for patients with HCC, but that: "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."

Mr Dillon noted that a greater number of high-cost treatments are now being recommended thanks to NICE's new approach to appraising drugs that extend life.

"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," he claimed.

Professor Peter Johnson, Cancer Research UK's chief clinician, expressed the charity's disappointment with the decision.

"This drug has an effect in people with advanced liver cancer who are unable to have surgery or any other treatments, so we are disappointed that the manufacturers have been unable to reach an agreement to enable NICE to recommend this drug," he said.

Professor Johnson also noted: "It is particularly frustrating that cancer patients in the UK are unable to access this drug when it is routinely available elsewhere in the world."

Final NICE decisions are open to appeal, and the manufacturers, patient groups, professional associations and other interested parties have two weeks to lodge their complaint.

Final guidance from NICE is expected to be formally published in January 2010.