NICE rejects Nexavar for liver cancer
pharmafile | May 7, 2009 | News story | Research and Development, Sales and Marketing | Bayer, NICE, Nexavar
NICE has rejected Nexavar as a treatment for liver cancer, saying it is not a cost-effective use of NHS resources.
The decision is preliminary and still open to consultation, but it represents a blow for Bayer, which has already seen the drug rejected for use in kidney cancer this year.
Nicole Farmer, head of the company's UK oncology unit, said: "Bayer Schering Pharma is gravely disheartened by this latest NICE announcement."
Nexavar is licensed for treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer, in cases where surgery or loco-regional therapies have failed or are unsuitable.
Bayer's data show it is the first therapy to show a survival advantage for patients with advanced HCC, and it is proven to extend overall survival by 44% compared to best supportive care alone, as well as maintaining quality of life.
NICE's appraisal committee agreed Nexavar was clinically effective for advanced HCC patients, but rejected the drug on grounds of poor cost-effectiveness.
It said the cost of £64,800 per quality assessed life year (QALY), was "substantially higher than those normally considered to be an acceptable use of NHS resources".
In its response, Bayer said the decision undermined the government's own promise to improve NHS access to cancer treatments.
Farmer added: "The time it has taken to review Nexavar in advanced liver cancer, and the decision to not recommend it, clearly undermine the government's own cancer strategy particularly for a disease for which the mortality is increasing. This is a major blow for UK HCC 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."
Final NICE guidance is expected later this year.
A blow for Bayer
The rejection is a setback for Bayer, as Nexavar is one of the company's top new drug hopes, along with anti-blood clotting pill Xarelto.
Nexavar has proved clinically effective against liver and kidney cancer and is marketed in both indications, though NICE has also rejected it for use in kidney cancer patients.
Sales of the drug grew 82% to $678 million in 2008. Onyx, Bayer's partner for the treatment, has forecast that revenues will reach as high as $875m this year and cross the $1 billion threshold in 2010.
The companies are also pursuing approvals for use against lung and breast tumours.
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