After FDA approves Gilead's new three-in-one combination AIDS treatment today, AHF challenges drug company over steep price — over $20K per patient, per year at Wholesale Acquisition Cost (WAC) — a price that will strain the nation's struggling network of AIDS Drug Assistance Programs (ADAP). Over 9,000 low-income HIV/AIDS patients in 13 states are on waiting lists today to access lifesaving medications via ADAP; in 2010, Gilead had $6.5 billion in AIDS drug sales, with a 36.5% profit margin.By AIDS Healthcare Foundation
Los Angeles, CA
Following FDA approval of Gilead Science’s Complera, its new three-in-one combination AIDS treatment earlier today, AIDS Healthcare Foundation (AHF), the largest global AIDS group, challenged the California drug company over the steep price of the antiretroviral therapy—over $20,000 per patient, per year at Wholesale Acquisition Cost (WAC)—a price that is certain to further strain the nation’s already struggling network of AIDS Drug Assistance Programs (ADAPs). ADAPs are federal and state funded, state-run programs that provide life-saving HIV treatments to low income, uninsured, and underinsured individuals living with HIV/AIDS nationwide. As Gilead executives—including CEO John C. Martin—celebrate FDA-approval of Complera today, over 9,000 vulnerable HIV/AIDS patients in 13 states remain on waiting lists to access lifesaving medications through ADAP. In addition, thousands more have been dropped or entirely shut out from the programs as more states permanently restrict eligibility due to state budget crises exacerbated by the high cost of drugs.
Complera is a once-a-day combination pill consisting of Gilead’s Truvada (emtricitabine/tenofovir) and Tibotec Pharmaceuticals’ Edurant (rilpivirine). According to the Dow Jones News Service, “Complera is the second complete antiretroviral treatment regimen for treatment-naive adults—those new to HIV therapy—in a single once-daily pill. The first, Atripla, is marketed by Gilead and Bristol-Myers Squibb Co. (BMY).”
“Gilead set the Wholesale Acquisition Cost of Complera at $20,400 per patient, per year. By comparison, Gilead’s Atripla was introduced five years ago at a Wholesale Acquisition Cost of $13,800 per year. Because prices for ADAP and other struggling government programs are pegged to the introductory price of the drug, Complera will end up costing these hard-hit programs thousands of dollars more per year than Atripla and other combination therapies,” said Michael Weinstein, President of AIDS Healthcare Foundation. “Considering that Gilead’s pharmaceutical contribution to the product—Truvada—has been around since 2004, this is a dramatic and unwarranted escalation of drug pricing and part of a disturbing trend to introduce each new AIDS drug at a higher and higher price—particularly for treatments that are to be taken for a lifetime.”
Informally, Complera is being referred to as ‘B-tripla’ a follow up treatment to Gilead’s successful—and wildly profitable—Atripla, a combination of Gilead’s Truvada (emtricitabine/tenofovir) and Bristol-Myers Squibb’s Sustiva (efavirenz).
Facts About Gilead and Atripla:
- Atripla was FDA-approved and introduced to the market in 2006 at a Wholesale Acquisition Cost of $13,800 per patient, per year
- ADAP Price: approximately $10,000 per year
- Atripla sales: $2.9 billion in 2010.
- Total Gilead AIDS Drug Sales in 2010: $6.5 billion
- Gilead’s Profit Margin: 36.5%
- John Martin’s total compensation over the past five years: over $200 million
Background on ADAP
With state budgets stretched thin and increasing numbers of unemployed workers without health insurance, many states have been forced to cap enrollment in their AIDS Drug Assistance Programs. Currently, there are 9,036 individuals on waiting lists to receive lifesaving AIDS medications in 13 states, with hundreds of patients in need are being added to the waiting list each month. In addition, several states have recently capped further enrollment in their ADAPs or are sharply reducing eligibility for their programs based on a percentage of Federal Poverty Level (FPL) income (in some cases cutting the FPL-eligible income from 400% to 200%), effectively denying needy patients access to medications, yet because enrollment is officially capped—or eligibility eliminated—these additional patients are never formally added to the states’ ADAP waiting list rosters.
Nationwide, ADAPs serve over 165,000 people, accounting for one third of people on AIDS treatment in the U.S. Unfortunately, the need for these programs expands every year, as more and more people become infected and diagnosed with HIV/AIDS; each year thousands of newly diagnosed HIV patients turn to ADAPs because they cannot afford their medicines.