The FDA’s release said that Gilead must conduct postmarketing studies "to help further characterize the drug’s safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs."
Concerns About Price
Despite the novelty of a four-in-one, single-dose HIV treatment, not everyone in the HIV/AIDS community has been enthusiastic about the prospects for the drug’s approval, particularly one expected to be priced at a premium to existing regimens.
On Aug. 17, the AIDS Healthcare Foundation (AHF) announced it was requesting that state Medicaid and AIDS Drug Assistance Programs (ADAPs), as well as private insurers, place Quad on prior authorization because the four-drug combination has not been shown to have a significant efficacy or safety advantage over existing treatments.
Prior authorization will "ensure that Quad is only prescribed to patients when there is a documented need for it, and also will help ensure access for people with HIV/AIDS to these safety net programs," AHF said, adding that it has worked with other groups in urging Gilead not to price Quad higher than Atripla, which is currently the most prescribed HIV/AIDS medication.
Gilead’s press release on the approval reports that the company is working with the ADAP Crisis Task Force to provide discounts in state ADAPs, and notes that Stribild will be covered by the company’s Advancing Access Patient Assistance Program as well as the firm’s copay coupon programs for patients with private insurance.
Editor’s note: This story appears courtesy of "The Pink Sheet," a weekly Elsevier publication covering pharmaceutical business and policy issues. To learn more, contact customer care at 800-332-2181 or sign up for a free trial.