It is looking unlikely that patients in the UK with liver cancer will be able to get treatment with Bayer’s Nexavar on the NHS, after a National Institute for Health and Clinical Excellence appraisal committee turned down the drug last week.

The Institute has published its preliminary recommendations in an appraisal consultation document stating that it plans to reject the use of Nexavar (sorafenib) in patients for whom surgical or loco-regional therapies have failed or are not suitable.

Despite concluding that Nexavar is a clinically effective treatment for this patient group, at a cost of £64,800 per QALY gained it failed to fall within the constraints of NICE’s cost-effectiveness threshold. Furthermore, although the drug met the criteria for consideration under new guidelines for end-of-life therapies, the Committee still did not consider it to be a cost-effective use of NHS resources.

Bayer is understandably disappointed with NICE’s recommendations, which come just weeks after funding for Nexavar was rejected for patients with kidney cancer because it was also considered too expensive in that setting.

But according to the firm, Nexavar is the first systemic treatment to show a survival advantage for patients with advanced liver cancer, and is proven to extend overall survival by 44% compared to best supportive care alone. In addition, there is an urgent need for new effective therapies as the incidence of liver cancer is on the rise and the disease kills more than 3,000 people a year in the UK.

In a statement to PharmaTimes UK News, a Bayer spokesperson commented that it has taken the Institute a year and a half to review Nexavar for liver cancer, and that during this time many patients have been fighting for access to the drug in the hope that it would ultimately be funded on the health service.

“The decision to not recommend Nexavar is a major blow for UK hepatocellular carcinoma patients who will be denied access to the only effective systemic treatment available for their condition, a treatment that is readily available to patients in other European countries”, the company said.

Conflicting advice
Furthermore, Bayer argues that the decision “directly conflicts with current UK and global guidelines for recommended treatment of HCC”, because recent treatment guidelines by the Hepatocellular UK Group “clearly state that sorafenib is the standard of care for patients with advanced HCC for whom no potential curative option is available”.

In Bayer's opinion, “patients with advanced HCC should be able to access the latest specialised medicines via the NHS” to enable doctors to “provide the best possible care for patients and allow as good a quality of life as possible at such an important time”.

NICE’s recommendations are now open for consultation and the closing date for any comments is May 29, with a second appraisal meeting due on June 11.