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UK Watchdog Blocks Bayer Liver Drug
By STEVE MCGRATH
Of DOW JONES NEWSWIRES

LONDON -- In another sign of growing opposition to high cancer-drug prices, a U.K. regulator Thursday said Britain's state health system shouldn't pay for the liver-cancer drug Nexavar, calling its price tag "simply too high."

National Health Service money could be better spent on cancer treatments offering better value for money, the country's healthcare cost watchdog, the National Institute for Health and Clinical Excellence, or NICE, said in a statement.

Nexavar, also known by the generic name sorafenib, is made by Bayer AG (BAYN.XE) and Onyx Pharmaceuticals Inc. (ONXX). It costs about GBP 2,900 per month, according to NICE.

"We were disappointed not to have been able to recommend the use of sorafenib, but after carefully considering all the evidence...sorafenib does not provide enough benefit to patients to justify its high cost," NICE Chief Executive Officer Andrew Dillon said in the statement.

NICE is known as a tough judge of drug costs, having rejected a number of other pricey treatments in the past. Earlier, it rejected Nexavar for kidney cancer, calling it too costly for that condition, as well. Its decisions often draw fire from patient-support groups, which say the watchdog is putting lives at risk.

Insurers and state healthcare systems worldwide are increasingly balking at the high cost of drugs for cancer and other diseases. Some, like NICE, now weigh a drug's clinical benefit against its cost before deciding to pay for it.

Bayer said it will appeal the decision. After NICE rejected Nexavar in a preliminary review earlier this year, Bayer offered to provide every fourth pack for free, but that concession didn't satisfy NICE. Drug companies negotiating with NICE sometimes offer free product instead of lowering their price, because they fear a concession on price would lead other countries to demand lower prices, too.

"We believed we had satisfied NICE's criteria for how Nexavar would be assessed. However, the "goal posts' appeared to have moved," Nicole Farmer, head of Bayer's oncology unit in the U.K., said in a statement Thursday.

Nexavar, which generated global sales of EUR462 million in 2008, has been approved for sale in more than 70 countries for advanced kidney cancer, and in more than 60 countries for liver cancer.

NICE was considering Nexavar to treat advanced hepatocellular carcinoma (HCC) in patients who are unable to have surgery or other treatments. In these patients, Nexavar extends life by at least three months, NICE said, calling the drug "clinically effective" but not "cost-effective."

A large U.K. cancer charity criticized NICE's decision, but also expressed disappointment in the drug companies.

"This drug has an effect in people with advanced liver cancer who are unable to have surgery or any other treatments, so we are disappointed that the manufacturers have been unable to reach an agreement to enable NICE to recommend this drug," Cancer Research U.K. said in a statement.

"It is particularly frustrating that cancer patients in the U.K. are unable to access this drug when it is routinely available elsewhere in the world," the statement said.

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