Express Scripts cautions over price of Gilead Sciences' hepatitis C drug Sovaldi: report

US pharmacy benefit manager Express Scripts warned that the price of Gilead Sciences' Sovaldi (sofosbuvir) is unsustainable and plans to ask its clients to join a coalition that would stop using the oral hepatitis C treatment once similar drugs are approved, Bloomberg reported Tuesday. Sovaldi, which was approved by the FDA last year, costs $84 000 for a 12-week treatment course.

"Never before has a drug been priced this high to treat a patient population this large, and the resulting costs will be unsustainable for our country," remarked Express Scripts' chief medical officer Steven Miller. "What they have done with this particular drug will break the country," Miller said, adding "it will make pharmacy benefits no longer sustainable. Companies just aren’t going to be able to handle paying for this drug." According to Bloomberg Industries analysts Andrew Berens and Thomas Smith, Sovaldi may generate sales of $10 billion in 2014. Miller noted that if everyone with hepatitis C was treated with Gilead's drug, the cost would exceed $300 billion.

"Gilead could have a great year this year and lose all its market share a year from now...when there will be competitors in the marketplace," Miller suggested. AbbVie said in January that it plans to start regulatory submissions early in the second quarter for its all-oral, interferon-free therapy regimen for patients with hepatitis C, with an anticipated US launch in 2014. The regimen combines ABT-450 and ritonavir co-formulated with ABT-267, and ABT-333, with or without ribavirin. "The companies that will be second and third to the market here will have to play catch up," Miller remarked, although he said he hopes they will talk to payers before setting a price. "We could shift the market share as soon as a competitor comes out. We need to start a national debate on fairness in drug pricing," Miller commented.

In a report issued Tuesday, Express Scripts estimated that spending on specialty drugs, which grew 14.1 percent last year, is set to increase "significantly," growing an additional 63 percent between 2014 and 2016. The pharmacy benefit manager noted that the growth in spending on specialty medications will be led by hepatitis C therapies, with estimates that the US will spend 1800 percent more on treatments for the disease in 2016 than it did last year. "The current pricing mentality around innovative products is unprecedented and unreasonable," Miller commented, adding that along "with many of the country's largest plan sponsors, we are going to drive toward a pricing environment that is fair for patients, payers and manufacturers."

Last month, members of the US House Energy & Commerce Committee requested that Gilead provide more information on how the company determined the cost of Sovaldi. For related analysis, see ViewPoints: Pharmacy benefit managers threaten to run with Congress' baton on Sovaldi pricing – Is Gilead Sciences a victim of its own success? and Spotlight On: The Sovaldi pricing debate – 5 key questions.

For further information on the hepatitis C market, see KOL Insight: Hepatitis C: Game changing regimens to revolutionise treatment landscape.

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