The National Institute for Health and Clinical Excellence has been accused of “acting unfairly” in barring patients with liver cancer access to Bayer’s Nexavar on the National Health Service, an appeal board has heard.

The appeal panel convened last Friday to hear Bayer’s objections to the cost watchdog’s Final Appraisal Determination, published in November after two years of consultation, which denies patients with the disease from treatment with the drug on the basis that it is too expensive for use on the NHS.

But while Institute agreed that the drug is indeed clinically effective, its calculations churned out a cost of £52,600 per QALY (quality-adjusted life year) gained, which, it argues, fails to offer the NHS value for money, even taking recent guidance on appraising so called end-of-life drugs and a patient access scheme proposed by Bayer, under which it would pick up the tab for every fourth pack of the medicine, into account.

Its decision sparked widespread outcry as Nexavar (sorafenib) has been hailed as the first systemic therapy to show a survival advantage for patients with advanced stage disease in 30 years, and, in clinical trials, was proven to extend overall survival by 44% compared to best supportive care alone.

“In rare cancers such as HCC, the statistically proven benefit and quality of life that sorafenib can offer patients is unique,” said Mr Graeme Poston, Director of the Liver Surgery Unit at Aintree University Hospitals NHS Foundation, and added that that is why “so many members of the oncology community in the UK have spoken out publicly against [NICE’s] decision”.

Ignoring innovation?
According to Bayer, in rejecting Nexavar the Institute has “failed to place adequate weight on innovation and has therefore acted unfairly and not fulfilled its obligations to the Secretary of State in considering the long term benefits of innovation to the NHS”. Its appeal also argues that the Appraisal Committee failed to explain why it changed its conclusions on overall survival following treatment with the drug, and that NICE acted in a “non-transparent and unfair manner” by failing to reveal the degree to which evidence on appropriate survival extrapolation methods was considered.

“It is so frustrating that for the 600 liver cancer patients who could really benefit from Nexavar, there still remains the chance that they will be denied,” said Nicole Farmer, Business Unit Head of Bayer Schering Pharma Oncology in the UK, and she noted the company is hoping that NICE “takes this opportunity to reconsider some of the data and ensures that real innovations in healthcare, like Nexavar, are made available to all who need it, not just those who could afford to pay privately”.

NICE will issue their final ruling in March, Bayer said.