NICE rejects Bayer’s liver cancer drug

pharmafile | May 26, 2010 | News story | Sales and Marketing NICE, Nexavar, patient access scheme 

Bayer’s liver cancer drug Nexavar has been rejected by NICE after it deemed the drug too costly for a marginal benefit.

The company had tried to mitigate Nexavar’s (sorafenib) high cost by offering the NHS a patient access scheme whereby Bayer would provide every fourth pack free, but this was not enough to sway the cost effectiveness body.

NICE’s chief executive Andrew Dillon 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’, sorafenib does not provide enough benefit to patients to justify its high cost.”

NICE was assessing Nexavar’s use in advanced hepatocellular carcinoma (HCC) and has previously rejected the drug as a first- and second-line treatment for renal cell cancer.

The drug’s submission to NICE showed it increases survival in HCC by a further 2.8 months on average after surgery, 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.

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 cost-effectiveness body has received criticism for its methodology and the new coalition government is set to reform the body and introduce a value-based pricing system that will assess medicines’ costs based on value.

In response to recent criticism, Dillon says that NICE has changed its approach to appraising high cost treatments that can potentially extend life for terminally ill patients. He believes that this means that more cancer drugs are now being recommended.

Dillon added: “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.”

Nexavar to be presented at oncology forum

Meanwhile, Bayer will be presenting more clinical data on Nexavar at the 46th American Society of Clinical Oncology annual meeting (ASCO). 

Dimitris Voliotis, VP of global clinical development oncology at Bayer HealthCare, said: “We have built a strong foundation with Nexavar in the treatment of patients with unresectable liver cancer and advanced kidney cancer and are committed to continuing research across tumour types and in a variety of treatment settings to determine the full potential of this therapy for cancer patients.”

ASCO will be running from 4-8 June in Chicago and will see new clinical trial data from the likes of Roche, Bayer and Amgen.

Ben Adams 

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