AIDS Healthcare Foundation (AHF) announced that California State Treasurer Bill Lockyer has sent a letter to California-based drug company, Gilead Sciences, Inc. urging the company to set an initial price on its latest HIV/AIDS drug combination—which is known as the 'Quad'—that is "…sensitive to ongoing state budget difficulties," and which will also "…provide the means to keep people with HIV/AIDS alive and as healthy as possible."
“AHF believes there is simply no justification for the expected high price of the Quad. Unreasonable drug prices are putting an unbearable strain on taxpayer-funded, cash-strapped State AIDS Drug Assistance Programs in California and around the country, ultimately limiting access to lifesaving HIV/AIDS treatment to those most in need.”
In a letter dated June 18, 2012 and addressed to Gilead CEO John Martin, Treasurer Lockyer also stated: "…I hope that Gilead will get ahead of the drug pricing curve and set a price for the Quad that will help to protect the financial integrity and security for the ADAPs in California and elsewhere." ADAPs stands for AIDS Drug Assistance Programs, a national network of federal and state funded aid programs that provide lifesaving HIV/AIDS medications to low-income patients. The State's General Fund budget provides funding that helps ensure patients obtain those medications. If the cost of the drugs rises, either ADAPs will not be able to serve as many patients, or other vital public services will suffer funding reductions.
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. In addition, thousands more Americans living with HIV/AIDS have been dropped from the program or made ineligible to receive medications through ADAP due to stricter eligibility requirements. With California's budget crisis persisting, last year the state considered potentially devastating cuts that would have resulted in Californians with HIV/AIDS losing access to lifesaving drugs.
"AHF would like to thank Treasurer Lockyer for expressing his concerns over the price Gilead may set for its key new HIV/AIDS drug and for urging the company to do its part to ensure that patients in need of lifesaving medicines are being served," said Michael Weinstein, President of AIDS Healthcare Foundation. "AHF believes there is simply no justification for the expected high price of the Quad. Unreasonable drug prices are putting an unbearable strain on taxpayer-funded, cash-strapped State AIDS Drug Assistance Programs in California and around the country, ultimately limiting access to lifesaving HIV/AIDS treatment to those most in need."
The "Quad"
Currently, there are several drugs in development that will pose a huge threat to ADAPs if they are priced higher than the current generation of antiretrovirals. Chief among them is Gilead Sciences' so-called "Quad." The Quad combines Truvada with Elvitegravir (an integrase inhibitor similar to Merck's Isentress) and Cobicistat (a blood booster similar to the decade-old Norvir). The FDA is currently reviewing Gilead's application to approve the Quad, but it is expected to hit the market sometime this year. The Quad may end up costing nearly two times as much as the most expensive drug ADAP purchases, and in some cases three or four times as much as other drugs.
Gilead's Quad Is Marginal Innovation With An Exponential Price Increase
Throughout the development process, it has become clear that the Quad is not a leap forward in drug innovation, and will not provide a superior clinical benefit over Atripla and other existing treatments. For example, the drug itself shares a primary active ingredient with Atripla (Truvada), which is then combined with other existing classes of HIV therapies. In fact, the Quad would not even be considered a four drug combo if not for the need to combine Elvitegravir (the integrase component) with a blood-level booster (Cobicistat) to increase its effectiveness (other integrase inhibitors, both on the market and in development, do not need to be boosted with a separate medication). In addition, the clinical trials on the Quad were specifically designed to compare its safety and efficacy to that of Atripla. Not surprisingly, these trials showed that it was clinically "non-inferior" to Atripla.
Exclusion of indigenous voices hinders HIV progress in Latin America