August 23, 2012
Some lawmakers and AIDS advocates are worried about the potentially high price of a once-daily AIDS treatment that US regulators are expected to approve soon. The price for Gilead Sciences Inc.'s Quad will not be established until it gains Food and Drug Administration approval; however, analysts have estimated the price will be $27,000-$34,000 per patient annually. In the spring, an FDA advisory panel recommended approval, and the agency's official decision is anticipated Monday.
Last week, 20 California lawmakers urged the state Department of Public Health to use its leverage to obtain lower prices for antiretroviral therapies for poor patients. Earlier this month, 14 congressional Democrats wrote to Gilead's CEO, voicing concern about Quad possibly being too costly.
Gilead worked out a freeze on Quad's price through 2013 for state AIDS Drugs Assistance Programs. Even so, some people fear its cost could still prove too much for public treatment and private insurance programs.
"Gilead now has a significant amount of market share, so people are particularly focused on the way in which this is priced," said Dana Van Gorder, executive director of San Francisco-based Project Inform, an advocacy organization. "We're definitely hopeful this is never priced as high as has been rumored."
Quad could cost 38 percent more than Gilead's Atripla, the members of Congress noted. In clinical trials, Quad proved slightly more effective than Atripla, which wholesales for $21,000 per patient annually. For ADAPs, Atripla costs about $10,000 per patient yearly.
Gilead officials would not discuss pricing ahead of FDA's decision. However, spokesperson Erin Rau pledged in an e-mail that the company is "committed to ensuring patients can access the therapies we develop." Gilead offers in-house co-pay and patient-assistance programs, and other charitable efforts to expand access, Rau said.