Members of the US House Energy & Commerce Committee requested that Gilead Sciences provide a briefing on how the company determined the "extraordinarily high cost" of its recently approved hepatitis C therapy Sovaldi (sofosbuvir), which is priced at $84 000 for a 12-week treatment course. "Our concern is that a treatment will not cure patients if they cannot afford it," the lawmakers said in a letter addressed to CEO John Martin.
The committee members also asked Martin to specify what steps are being taken to ensure access to the oral drug among low-income patients and to key government or private-sector purchasers. Further, they want Gilead to clarify how the company benefitted from the FDA's expedited review of the drug under the agency's priority review programme, as well as the potential public health impact of decisions by payers not to cover the treatment. The committee members noted that Colorado and Pennsylvania have already said their Medicaid programmes will be limiting use of the drug to "only the sickest patients," while pharmacy benefit manager Express Scripts is "encouraging some doctors in its networks to delay prescribing Sovaldi." The lawmakers called on the company to submit its briefing by April 3.
The drugmaker's shares declined as much as 6 percent on the news. Gilead stated that it "heard the concerns raised in the letter and [has] reached out to a number of members of Congress prior to this letter to address those concerns." The company added that "we have been working with a number of stakeholders, including federal and state officials, to share the scientific and medical evidence."
Terry Haines of ISI Group described the letter as a starting point to put pressure on the company, "with the goal of getting Gilead to significantly lower the price of Sovaldi." However, Height Securities analyst Justin Simon suggested the request "is unlikely to affect the price of any currently marketed and priced products," and Michael Yee of RBC Capital Markets said that while "pricing discussions could generate headline concern…in our view, this underscores that the drug is going to be huge." Meanwhile, JP Morgan analyst Geoff Meacham noted that because of the high cure rates associated with Sovaldi, "Gilead is in position to 'guarantee a cure' to payers, thereby dramatically reducing the downstream economic burden of a liver transplant, risk of liver cancer or cirrhosis."
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