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Gilead Sciences will price its soon-to-be-approved hepatitis C combination drug Harvoni close to the near-$100,000 cost of the current 12-week regimen of Sovaldi plus pegylated interferon and ribavirin, Gilead President and CEO John Milligan said Wednesday (Oct. 1). Insurance companies and others, including employers, hospitals and state officials, are pressuring Gilead to lower Sovaldi's price, and they anxiously await to see how the company prices Harvoni.
Hepatitis C patients without scarring of the liver and with low viral loads will be given an eight-week regimen of Harvoni, Milligan said. The price per pill of Harvoni will be the same whether patients take it once a day for eight weeks or 12 weeks, he said.
FDA on Oct. 10 is expected to approve Harvoni, which combines Sovaldi and ledipasvir in a once-daily pill. The European Medicines Agency last week approved Harvoni. Sovaldi already cures some 95 percent of people with the most common type of hepatitis C, and the new combination drug is expected to work even better and faster.
Despite the drug's incredible effectiveness, Sovaldi sparked controversy with its $84,000 per 12-week regimen price tag, and policymakers met at Brookings Institution on Wednesday (Oct. 1) to debate the drug's value and how it should be reimbursed. Many doctors prescribe Sovaldi with Johnson & Johnson's Olysio, even though FDA did not approve the drugs in combination. The drugs together cost about $150,000, but Milligan said Harvoni will not be priced based on the cost of Sovaldi plus Olysio.
Policymakers also are paying close attention to Sovaldi because it is expected to be a harbinger of other so-called specialty drugs that work well and treat common conditions. Drug makers and many patient advocates argue that the price is justified because it is line with the long-term costs of treating hepatitis C. Others counter that Medicaid and private health plans should not be required to pay in a lump sum costs that normally would be spread over decades and by several payers. They also contend that the health care system will not break even because many of those cured patients will inevitably get sick again. Many policymakers also suspect that the current estimate of the infected population, 3.2 million, is largely underestimated. The Centers for Disease Control and Prevention is updating that figure. -- John Wilkerson (jwilkerson@iwpnews.com)
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