NICE reconsiders Nexavar in HCC

NICE is to convene to decide the fate of Bayer Schering Pharma’s Nexavar (sorafenib) in the treatment of advanced hepatocellular carcinoma (HCC).

The Institute will consider Bayer’s appeal (submitted in December 2009) of its draft negative Final Appraisal Determination (FAD) for Nexavar in HCC, which was published after nearly two years of consultation.

Bayer appealed on the grounds that NICE failed to act fairly and in accordance with its own published procedures, as well as failing to consider the long-term benefits of innovation.

Following the outcome of the hearing, NICE will issue its final ruling in March 2010.

Nicole Farmer, Business Unit Head of Bayer Schering Pharma Oncology in the UK, said: “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. We really hope 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.”

Since NICE’s negative ruling in November, patient groups and clinicians have been involved in a high-profile media appeal, including a systematic letter writing campaign by oncologists to NICE and the media.

Nexavar is the first systemic drug for advanced HCC to show a significant survival benefit after 30 years of comparative trials, and has demonstrated a 44% increase in survival for advanced HCC patients compared to best supportive care alone.

Professor Karol Sikora, Professor of Cancer Medicine and Medical Director of CancerPartnersUK, said: “Since NICE’s decision not to fund the drug in November, many clinicians (a number of whom would have been involved in the UK trials of the drug) have been put in the painful position of having to deny their patients the only survival option for them.

“As we reach the end of this laborious process, which has left both patients and clinicians in limbo for far too long, we can only hope that NICE will use this final window of time to properly consider the very strong recommendations from UK oncologists, who only want the best for their patients.”

Cases of liver cancer have almost tripled over the past three decades, according to figures recently published by Cancer Research UK. In 1975 there were 865 cases of primary liver cancer in the UK, and in 2006 that had risen to around 3,200 new cases. HCC accounts for 80–90% of these primary liver cancers.