Gilead Sciences announced on Monday that Stribild, a four-in-one combination HIV treatment in a single pill, received FDA approval. In clinical trials submitted to the FDA, the drug was found to be as effective as Atripla and has the advantage of fewer side effects. But Stribild has a substantially higher price than current HIV combination drugs.
Gilead’s stated wholesale price of Stribild as $28,500 per patient, per year has created controversy since before its release. Democratic members of Congress sent a letter to dated August 1 urging Gilead to use sustainable pricing that would not burden the AIDS Drug Assistance Program. Andrew Weinstein, president of AHF, stated to the New York Times that Gilead’s pricing of Stribild “shockingly irresponsible.”
Gilead maintains that Stribild pricing is comparable to other HIV medications on the market. Stribild is priced at 39 percent higher than Complera, a three-drug HIV regimen approved only one year ago. At the time of Complera’s approval, there were concerns about the $20,500 wholesale cost of Atripla, which is marketed by Gilead and Bristol-Myers Squibb.
HIV drug prices have increased substantially, even during the current economic downturn. Atripla, a combination therapy released in 2006 was priced at $13,800 per person, per year. Atripla’s current wholesale prices have risen to the level of Complera’s at $20,500.
Rising drug costs and HIV cases, combined with tighter state budgets may burden the AIDS Drug Assistance Program (ADAP) to the breaking point. Kaiser Family Foundation reports that ADAP provided HIV drug benefit to 138,000 people in 2011, with a current waiting list totaling 2,030 HIV-positive individuals. Many states including California, Colorado, Georgia, and Virginia are considering measures to cut ADAP spending.
The AIDS Healthcare Foundation (AHF) announced on Wednesday their intention to file a ballot measure in San Francisco to reduce the cost of prescription drugs. The ballot will ask voters if they agree that San Francisco should negotiate with companies for lower drug prices and press the state and federal government to pass legislation to cut prices the government pays by one-third. AHF specifically targets Gilead Sciences, which is based in the Bay Area.
The government may not need to negotiate with companies for name brand drugs. The patents of the most widely used HIV drugs will expire in the next few years. The Department of Health and Human Services contracted with physician researcher Rochelle Walensky on the costs and benefits from switching from the single pill Atripla to 3 generic medications. As reported by Amy Maxmen in Nature, Dr. Walensky estimated cost savings of $920 million in the first year alone. Atripla was found slightly superior to generics in survival, adding 4.4 months to a person’s life.
ADAP waiting lists do not accurately describe unmet need for HIV treatment in the United States. The Centers for Disease Control has reported in July that of the 1.1 million people with HIV, only 37% are retained in care and that only 25% have undetectable levels of virus in their blood. What this means is that more than 67 percent of people with HIV or 600,000 people have some unmet HIV drug treatment need. Generic drugs may prove promising in extending scarce public dollars.