U.K. Cost Regulator May Reject Gilead’s Sovaldi Treatment

The U.K.’s health-cost regulator said it may reject Gilead Sciences Inc.’s $60,000 hepatitis C drug Sovaldi, and asked for more data before deciding whether the British government should pay for the treatment.

Gilead lacks evidence on Sovaldi for some patient groups, the National Institute for Health and Care Excellence said in an e-mailed statement today. The agency said it has asked Foster City, California-based Gilead for more information, including about Sovaldi’s cost-effectiveness in patients with and without liver damage and HIV.

Sovaldi, approved in Europe in January, has been shown in trials to clear the hepatitis C virus in more than 90 percent of patients, transforming the disease from a potentially deadly malady to one that is easily curable. Still, the cost of the drug has sparked debate about which patients should get it. A standard 12-week course of Sovaldi, also known as sofosbuvir, costs 34,983 pounds ($59,385) in the U.K., NICE said.

“The committee is minded not to recommend sofosbuvir within its marketing authorization,” NICE said. It asked for more information to see whether the medicine is a cost-effective use of National Health Service resources.

Gilead said it will “provide the evidence requested to support a positive final recommendation to make sofosbuvir available to hepatitis C patients across England and Wales.” The company has until July 4 to respond to NICE’s draft guidance.

Significant Risk

The NHS in April agreed to pay for Sovaldi for about 500 patients in England and Wales who are at significant risk of dying or needing a liver transplant unless they receive the drug. The NHS in Scotland approved Sovaldi last week, with restrictions for some patients.

“It is surprising in the sense that the received wisdom had been that there would be approval,” said Graham Cooke, a clinical senior lecturer in infectious diseases at Imperial College London. “It’s possible that they’ll push back on the whole drug. That would seem to be unlikely. It is a good drug and there is a big need for it.”

Analysts predict the treatment will amass more than $9 billion in annual sales this year and more than $14 billion by 2017, according to data compiled by Bloomberg.

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