LOS ANGELES, Jun 11, 2012--The "Quad" will hit the market later this year and will likely be priced nearly two times as much as the most expensive drug that state AIDS Drug Assistance Programs purchase, without representing a significant improvement over existing medications
A coalition of AIDS advocates, spearheaded by AIDS Healthcare Foundation, have sent a letter today to the CEO of HIV/AIDS drug maker Gilead Sciences, Inc.--John C. Martin--urging the company not to "decimate ADAP [AIDS Drug Assistance Programs]" by pricing its latest HIV/AIDS drug combination--known as the "Quad"--higher than Gilead's Atripla, the most prescribed HIV/AIDS medication.
The letter to Mr. Martin was signed by fourteen 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 letter states: "We, the undersigned advocates and medical providers of the HIV/AIDS community, are concerned about the pricing of Gilead's "Quad" HIV drug. Over the past two years, Gilead worked to alleviate the impact of high drug prices on access to care by increasing its discounts to cash-strapped AIDS Drug Assistance Programs (ADAPs). This enabled thousands of people on ADAP waiting lists to finally access lifesaving care. This progress could now be completely undone by the pricing of the Quad."
The letter continues: "Based on the current market price (Average Wholesale Price per the PHS Guidelines) of comparable HIV antiretroviral components--Truvada, an integrase inhibitor, and a blood-booster--we are fearful the Quad could cost upwards of $34,000 per patient per year. This would make the Quad 38% more expensive than Atripla, the most commonly utilized combination HIV drug. Even taking into account the lower price available to ADAPs, it would still be unacceptable to force ADAPs to absorb a proportionally higher cost than Atripla for the Quad. This higher cost would result in, once again, cutting off lifesaving care to thousands of people. We request that Gilead show restraint in its pricing for the Quad and make it cost-neutral to Atripla and other similar single-tablet combination drugs. The price comparability should be extended to all payers, as the entire U.S. healthcare system is currently under great financial stress."
"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," said Michael Weinstein, President of AIDS Healthcare Foundation. "By contrast, pricing it beyond affordability could actually hurt Gilead's bottom line because ADAP and other programs may restrict Quad utilization due to its high price. Like AIDS advocates, the local and national officials who run these programs know that we have reached a turning point in the epidemic. 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."
As of April 19, 2012, there were 3,079 individuals on AIDS Drug Assistance Program (ADAP) waiting lists in 10 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.
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%
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.
The letter concludes: "Once again, we urge you to price the Quad cost-neutral to Atripla. Help us to truly end this epidemic."
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 166,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean the Asia/Pacific region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.
SOURCE: AIDS Healthcare Foundation