Glaxo's Tyverb Cancer Drug Fails to Win U.K. Backing
By Trista Kelley

(Bloomberg) -- GlaxoSmithKline Plc, Europe's largest drugmaker, failed to convince a U.K. agency that its Tyverb cancer medicine was cost effective, restricting most patients' access to the product.

Tyverb shouldn't be used as part of government-funded treatment for breast cancer for patients with the HER-2 gene, the National Institute for Clinical Health and Excellence said in a statement on its Web site. London-based Glaxo, doctors and patient groups have until the end of the month to weigh in on the preliminary decision.

Governments and insurers are demanding more proof that products can prolong life and reduce hospitalization and health costs. Tyverb combined with capecitabine, a chemotherapy pill that slows tumor growth, costs about 25,207 pounds ($49,718) a year for each patient, NICE said. Last month, the agency also rejected Roche Holding AG's 36,000 pound-per-year Avastin tumor treatment.

It's "increasingly difficult to show cost effectiveness'' of treatments for late stage cancer, Glaxo spokeswoman Gwenan White said in an interview. The company is working with NICE ahead of the agency's final decision on the drug, she said.

Glaxo rose 35.5 pence, or 3 percent, to 1,216 pence in London. The stock has declined 4.9 percent this year.

Quality of Life

NICE uses a measurement known as the cost per quality adjusted life year, or QALY, to determine how a medicine helps patients live longer or improve quality of life. The figure places an informal upper limit on what the National Health Service can spend to extend a person's life for a year. NICE's appraisal committees rarely back treatments that cost more than 30,000 pounds per QALY.

Tyverb, known as Tykerb in the U.S., is one of the medicines London-based Glaxo is relying on to help counter slowing growth in sales of its top-selling asthma drug Advair and diabetes pill Avandia and the loss of patent protection on other products. Tyverb is designed to treat patients with the HER-2 gene, which makes the disease more aggressive,

A panel of the London-based European Medicines Agency recommended approving Tyverb in April, saying the benefit of the drug outweighed the risk of liver damage, a concern that delayed clearance of the medicine in March.

Other Decisions

In June, Roche, the world's biggest maker of cancer medicines, refused to provide data on its Avastin tumor treatment to NICE. Avastin shouldn't be used as part of government-funded treatment for lung and breast cancer, NICE said at the time. The Basel, Switzerland-based company wouldn't provide information on the drug's clinical and cost-effectiveness, NICE said.

Drugmakers have complained about decisions by the London- based government funded agency, and earlier this year, Japanese drugmaker Eisai Co. won a U.K. court ruling to force NICE to disclose more data on how it determines which patients should receive the Alzheimer's drug Aricept.

The Court of Appeal in London ruled May 1 that the process used by the U.K. drug regulator was ``procedurally unfair.'' Tokyo-based Eisai wants to alter NICE rules to allow U.K. doctors more discretion to prescribe the medication.

While the ruling didn't force the regulator to change its guidelines, the agency will have to disclose its cost models that determine how to treat Alzheimer's patients, Eisai said.