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Apr 15, 2014

WHO, Express Scripts Attack Cost of Sovaldi

  • Gilead’s $84,000 price for Sovaldi (sofosbuvir) has made unlikely allies out of patient advocates, payers, politicians, and others angered by the sky-high cost of a 12-week treatment course of the new hepatitis C virus treatment.

    The World Health Organization (WHO) and Express Scripts joined the fray last week. WHO issued its first-ever guidelines on testing, treatment and prevention of hepatitis C, with the stated goal of persuading Gilead to lower the cost of treatment via Sovaldi.

    WHO said it would support efforts by countries to introduce the guidelines as part of their national treatment programs. That support, WHO said, will include assistance to make the new treatments available, as well as “consideration of all possible avenues to make them affordable for all.” WHO also said it will also assess the quality of hepatitis laboratory tests and generic forms of hepatitis medicines.

    “Hepatitis C treatment is currently unaffordable to most patients in need. The challenge now is to ensure that everyone who needs these drugs can access them,” Peter Beyer, Ph.D., senior advisor for WHO’s Essential Medicines and Health Products Department, said in a statement. “Experience has shown that a multi-pronged strategy is required to improve access to treatment, including creating demand for treatment. The development of WHO guidelines is a key step in this process.”

    Express Scripts, a pharmacy benefit manager that processes more than 1 billion U.S. prescriptions annually, last week urged its clients to join a coalition that will commit to stop prescribing Sovaldi once another Hepatitis C drug reaches the market. The coalition formation is consistent with earlier statements by Express Scripts that it may halt reimbursement of Sovaldi once other drugs become available.

    “It will make pharmacy benefits no longer sustainable. Companies just aren’t going to be able to handle paying for this drug,” Steven Miller, Express scripts CMO, told Bloomberg News, adding: “What they have done with this particular drug will break the country.”

    Express Scripts’ verbal volley came nearly a month after what turned out to be the most potent protest against Sovaldi so far: Three Democrats in the Republican-majority House of Representatives on March 20 requested “a briefing” on Sovaldi’s pricing from Gilead Sciences CEO John C. Martin Ph.D., complaining about “the extraordinary high cost of your drug.” The three cited Sovaldi’s price, which could nearly double when combined with other drugs.

    Gilead has defended its $1,000-a-pill pricing by noting that the cost of Sovaldi is lower than the cost of complications associated with hepatitis C treatment, such as liver damage or liver failure. “In our conversations with payers, pricing is a consideration, but efficacy, safety and treatment guidelines are equally important,” Gilead COO John Milligan told Bloomberg in January.

    Sovaldi is a once-daily oral nucleotide analog polymerase inhibitor designed to block a specific protein needed by the hepatitis C virus to replicate. Sovaldi is the first drug that has shown the safety and efficacy to treat certain types of HCV infection without the need for injection of interferon at the same time.

    Sovaldi won FDA approval in December following six months of review in which it received the agency’s priority review and breakthrough therapy designations, granted to investigational medicines deemed to offer major advances in treatment over existing options.

    Among the first to publicly take aim at Sovaldi was the AIDS Healthcare Foundation, a provider of medical care and/or services to more than 300,000 patients in the U.S. and 31 other countries. AHF President Michael Weinstein in January publicly urged state Medicaid directors to block Sovaldi from inclusion on their respective state Medicaid and other drug formularies.

    The drug was approved by the F.D.A. on December 6, 2013 and Gilead immediately announced that it would price the drug at $84,000 for a twelve-week course of treatment, making it one of the most expensive drugs ever marketed. Suggested treatment guidelines also require that Sovaldi be used with another drug, ribavirin (a nucleoside inhibitor), further adding to the cost of the prohibitively expensive course of treatment.

    “An anti-Gilead drug pricing campaign is clearly gaining momentum and picking up steam with both government and business officials showing considerable interest in Gilead’s pricing of Sovaldi,” said Michael Weinstein, President of AIDS Healthcare Foundation.



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