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Roche Rebuked by U.K. on $152,850 Breast Cancer Drug

The U.K.’s medical-cost oversight group rebuked Roche Holding AG (ROG) today for refusing a significant price cut to a breast-cancer drug that is used only for severe cases now, but may eventually be more broadly prescribed.

The medicine, Kadcyla, costs an estimated 90,831 pounds ($152,850) for the average 14 1/2-month course of treatment, the National Institute for Health and Care Excellence said today. NICE said that’s too expensive to add the drug to the National Health Service’s budget for routine funding, even though it helped patients.

Breast-cancer patients in England will still be able to get Kadcyla by applying through the state-run NHS’s 200 million-pound supplementary Cancer Drugs Fund. The flap over price foreshadows a bigger fight if the medicine, one of the most expensive cancer drugs sold in England, is approved for broader use and ultimately combined with another pricey new Roche breast cancer drug, Perjeta.

“We are really disappointed that Roche were not able to demonstrate more flexibility to help us make a positive recommendation,” NICE Chief Executive Officer Andrew Dillon said in a statement today. “The company is well aware that we could not have recommended Kadcyla at the price it proposed.”

The drug would have had to be discounted by 60 percent to meet NICE’s cost-effectiveness threshold, Roche spokeswoman Claudia Schmitt said in an e-mailed statement. She called the price cut “simply not achievable.” Neither Roche nor NICE would say how big a discount the Swiss drugmaker did offer.

Inoperable Cancer

Kadcyla is approved for inoperable cancer that has spread and stopped responding to other treatments. It already has about 43 percent of that market in the U.S., according to Roche’s partner on the drug, ImmunoGen Inc. (IMGN) Roche has said it will present results before the end of the year from a trial that may broaden the market considerably.

The 1,095-patient Marianne trial tests Kadcyla and Perjeta together in metastatic breast cancer patients who haven’t already tried and stopped responding to other treatments.

Roche is working on “innovative pricing models” in the event combination therapies like Kadcyla-Perjeta are proven to work, Schmitt said. Perjeta was Roche’s fastest-growing top-20 drug in the first half. Its sales almost quadrupled. Kadcyla’s sales nearly tripled.

About 55,000 people are diagnosed with breast cancer each year in the U.K., and almost 12,000 die from the disease, according to nonprofit group Breast Cancer Care. Like Herceptin, Roche’s third-biggest-selling drug and the flagship in its breast-cancer line, Kadcyla and Perjeta are for patients whose cancer tests positive for the protein HER2. That’s about a fifth of the breast cancer patient population.

The Cancer Drugs Fund has received 233 requests for Kadcyla in the first quarter of this fiscal year, according to NHS spokeswoman Emma Reynolds, who said about 1,000 patients a year will probably get the drug.

Roche said it will appeal today’s final draft guidance.

To contact the reporter on this story: Naomi Kresge in Berlin at nkresge@bloomberg.net

To contact the editors responsible for this story: Kristen Hallam at khallam@bloomberg.net; Phil Serafino at pserafino@bloomberg.net Kim McLaughlin

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