Gilead’s Sovaldi Has Unclear Cancer Benefit, German Agency Says

Gilead Sciences Inc.’s hepatitis C drug Sovaldi offers a benefit for patients, though the extent to which it prevents liver cancer is unclear, according to Germany’s drug-review panel.

While data submitted by Foster City, California-based Gilead showed Sovaldi can clear the virus, there was no proof that the drug helped prevent deaths, the Institute for Quality and Efficiency in Health, or IQWiG, said in a statement today.

Sovaldi, approved in Europe in January, sells for about 49,000 euros ($68,000) in Germany for a 12-week course. Germany’s Federal Joint Committee will use IQWiG’s recommendation to make a final ruling on the drug’s benefit for patients, a key step in negotiating the price in that country.

“It is currently accepted that patients with no detectable hepatitis C virus in the blood are at lower risk of liver cancer,” IQWiG said. “However, it is unclear how many cases of liver cancer can in fact be prevented by sofosbuvir,” the agency said, referring to the scientific name for the pill.

Drugmakers including Bristol-Myers Squibb Co. and Johnson & Johnson are competing to reach the multibillion-dollar market for hepatitis C drugs with new treatments that are more convenient and have fewer side effects than current therapies including injections. The cost of such medicines have attracted scrutiny from health insurers and lawmakers.

Express Scripts Holding Co., the largest benefit manager, has said it may try to start a price war once competing medicines from AbbVie Inc. and Merck & Co. reach the market. CVS Caremark Corp., the second-biggest pharmacy manager, has said it might try to slow down the use of the drug.

Sovaldi had sales of $2.27 billion in the first quarter, Gilead said last week, beating the average analyst estimate by more than $1 billion.

Amy Flood, a Gilead spokeswoman, didn’t immediately respond to a voicemail and e-mail seeking comment on the German review outside of regular business hours.

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