March 5 (Bloomberg) -- GlaxoSmithKline Plc’s Tykerb costs too much to be recommended for routine use in women with advanced breast cancer, even after the drugmaker offered to cover the expense of the first 12 weeks of treatment, a U.K. agency said.

The National Institute for Health and Clinical Excellence only recommended use of the drug, also known as Tyverb or lapatinib, in combination with Roche Holding AG’s Xeloda in clinical trials. The draft guidance is subject to appeal, and a final recommendation hasn’t been issued to the National Health Service, said in an e-mailed statement. The agency, known as NICE, advises the state-run health system on the cost- effectiveness of medical treatments.

Tykerb extends patients’ lives by a few weeks and delays the progression of the disease compared with standard treatment, the agency said. Still, the medicine isn’t a cost-effective use of National Health Service funds, NICE said. London-based Glaxo offered to pay for the costs of the first 12 weeks of treatment. If the drug worked, then the health system would reimburse Glaxo under the company’s proposal, NICE said.

“Although lapatinib is not a cure and only offers a few weeks’ additional survival benefit, it could potentially help patients with brain metastases, which is why we have recommended this treatment when it is provided as part of clinical trials,” said Gillian Leng, NICE’s deputy chief executive officer, in the statement. “We hope this additional research will aid us in subsequent reviews.”

Possible Appeal

Glaxo will consider appealing the agency’s decision, company spokesman Stephen Rea said.

“We disagree with NICE’s decision and believe Tykerb is a valuable and important treatment for eligible patients,” Rea said in an interview. “This decision is particularly frustrating in that we have been flexible in our pricing structure by offering to bear the cost of Tykerb for the first 12 weeks of treatment. The NHS would then only pay for patients that continue to receive clinical benefit.”

Tykerb used with capecitabine, a chemotherapy medication, costs about 25,000 pounds ($35,265) a year for each patient, the agency said. The drug won a conditional marketing license from the European Medicines Agency in June.

In a separate statement, NICE said it “is minded not to recommend” Pfizer Inc.’s Sutent as a treatment option for gastrointestinal tumors “because of uncertainty in the economic analysis provided by the manufacturer.” The agency has asked New York-based Pfizer to provide further clarification on the analysis before an advisory committee meeting on April 8.

Bayer AG’s Xarelto blood-clot treatment won an initial positive recommendation from NICE, the Leverkusen, Germany-based company said today in a PR Newswire statement. The draft guidance recommends the drug as an option for patients having knee and hip-replacement surgery. Xarelto won European Union marketing approval in October.

To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net

Last Updated: March 5, 2009 10:07 EST