UK's NICE again rejects Bayer's Nexavar for advanced liver cancer, but company can, and will, appeal

Following a further appraisal, the UK's National Institute for Health and Clinical Excellence (NICE) has again decided against recommending the use of German drug major Bayer's Nexavar (sorafenib) under the National Health Service for advanced hepatocellular carcinoma (HCC) in patient for whom surgery or therapies in the region the cancer arose have failed or are not suitable, essentially because the drug is too expensive.

Nexavar, which has been shown to extend life, including the quality of life, by several months, in the UK costs around £3,000 ($5,000) a month for treatment. It has been approved ' and is routinely used ' in most European countries, including the likes of Romania, which can hardly be described as one of the region's rich countries.

£9 million annual cost to NHS

The cost to the NHS of treating them would be £9 million a year, a spokesman for NICE said, although Bayer, has offered to pay for every fourth packet of treatment bringing the NHS cost down to £7.7 million, which the NICE still deems too much.

Nexavar, which generated global revenues for the company of 462 million euros ($691.2 million) in 2008, has been approved in more than 70 countries for advanced kidney cancer, and more than 60 countries for liver cancer. Sales advancing by a currency-adjusted 29.6% to 161 million euros for the third-quarter 2009. After an initial rejection in May, Bayer submitted a new patient access scheme whereby the company offered to pay for every fourth pack of the drug. More than 3,000 people are diagnosed with liver cancer every year in the UK and their prognosis is generally poor. Only about 20% of patients are alive one year after diagnosis, dropping to just 5% after five years.

In line with the NICE technology appraisals process this draft guidance is now with consultees, who have the opportunity to appeal against the proposed guidance. The agency notes that it has not yet issued final guidance to the NHS, said the NICE.