AHF calls for reasonable pricing of Gilead’s Quad AIDS drug

AIDS Healthcare Foundation (AHF)Jul 7 2012

Today AIDS Healthcare Foundation, in response to recent press reports regarding drug manufacturer Gilead Sciences, Inc.'s new four-drug HIV/AIDS pill, known as the "Quad," renewed its call for company to price the drug reasonably, particularly in light of the fact that it represents only a marginal improvement over existing medications.

“It would be unconscionable for Gilead to price the Quad higher than similar drugs on the market, when it is only a marginal improvement over existing medications”

According the New York Times (AIDS: New Four-Drug Pill Taken Daily Tests Better Than Other Regimens, by Donald G. McNeil, Jr., July 2, 2012): "A new once-a-day pill combining four AIDS drugs has proved slightly better than two existing once-a-day regimens, according to studies published in The Lancet last week. The new pill, called Quad, had roughly the same side-effects rate, though some were different. For example, it appeared to cause more nausea but fewer rashes than Atripla, a common three-drug pill. It appeared to cause more kidney problems than a four-drug two-mix pill, but fewer patients stopped taking it."

The "Quad" will hit the market later this year and is expected to be priced higher than the most expensive drug that state AIDS Drug Assistance Programs (ADAPs) purchase, without representing a significant improvement over existing medications, says AHF. State ADAPs—which provide lifesaving HIV/AIDS medications to low-income Americans—is facing a funding shortage crisis. As of June 14, 2012, there were 1,963 individuals on ADAP waiting lists in 9 states, according to ADAP Watch, a publication of the National Alliance of State and Territorial AIDS Directors (NASTAD). Rising drug prices are a key contributor to the current ADAP crisis—the program simply cannot afford to provide medicines to an increasing number of people in need.

"It would be unconscionable for Gilead to price the Quad higher than similar drugs on the market, when it is only a marginal improvement over existing medications," said Michael Weinstein, President of AIDS Healthcare Foundation. "Ultimately, the cost to Gilead of producing the Quad will be a small fraction of its selling price, which means Gilead can show restraint on pricing and still make an enormous profit. To save lives, curb the spread of HIV, and lower long-term care expenses, it is imperative to get more patients tested and into antiretroviral treatment. This will be impossible if we continue to introduce new AIDS drugs, like the Quad, at prices higher than the drugs they replace."

Last month, AHF's call for Gilead to price the "Quad" reasonably was echoed by California State Treasurer Bill Lockyer who sent a letter to the California-based Gilead urging the company to set an initial price 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."

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."

Also last month a coalition of AIDS advocacy groups, spearheaded by AHF, sent a letter to the CEO of Gilead Sciences, Inc.—John C. Martin—urging the company not to "decimate ADAP [AIDS Drug Assistance Programs]" by pricing the "Quad" higher than Gilead's Atripla, the most prescribed HIV/AIDS medication. The letter to Mr. Martin was signed by prominent HIV/AIDS groups including: the ADAP Advocacy Association, Broward House, Community Access National Network and the Fair Pricing Coalition. To view the letter and a complete list of signers, please click here.

The sharp increases in AIDS drug costs are fueled by the skyrocketing prices of each new generation of drugs. By law, ADAP drug prices for existing drugs cannot increase more than inflation. However, there are no restrictions on the price charged for new drugs. The companies have exploited this fact, increasing the price of their new products by tens of thousands of dollars in order to offset the discounts they must provide to ADAPs and other programs.

This trend could not be clearer:

• Since 1995, the average price of new AIDS drugs has increased 163%

The "Quad"

According to AHF, there are currently 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 A Major Price Increase, says AHF

According to AHF, 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 HIV/AIDS drug 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.