AHF Renews Challenge to Merck on Price of AIDS Drug Isentress

AIDS Drug Initially Approved as a Salvage Therapy Gets FDA Nod for use as First Line HIV Treatment, which Vastly Expands Company’s US Market; Isentress Now the the Most Expensive First Line Therapy

By: AIDS Healthcare Foundation

Los Angeles, CA - July 24, 2009

AIDS Healthcare Foundation (AHF) today renewed its challenge to Merck and Co. Pharmaceuticals, over the steep price for its key HIV/AIDS drug, Isentress (raltegravir), an integrase inhibitor initially approved in October 2007 by the Food and Drug Administration (FDA) as a salvage therapy. The FDA recently expanded its approval of the drug for use as a first line course of treatment in HIV/AIDS, a move which both greatly expands the US market for the drug and makes Merck’s antiretroviral (ARV) Isentress the most expensive first line treatment.

“In light of the fact that Isentress now costs up to three times more than any other first line antiretroviral treatment and in recognition of the vastly expanded US market that this FDA approval for first line use now brings, we are asking that Merck do the right thing and significantly lower the price of Isentress,” said Michael Weinstein, AIDS Healthcare Foundation President. “The steep cost of this drug is symptomatic of the overall price spiral of AIDS drugs. As with many other AIDS drugs before it, the price has been simply out of reach for most AIDS patients, and Merck and other companies’ pricing for their AIDS drugs threatens to further limit the ability of Medicaid and AIDS Drug Assistance Programs nationwide to provide crucial medications to patient populations. And as Congress and the Obama Administration continue with the overhaul of the US healthcare system, I don’t know if I would want to be the pharmaceutical company laying claim to the have most expensive first line AIDS treatment.”

Currently, Isentress is up to three times more expensive than other first line antiretroviral treatments. Merck’s price per patient yearly (ppy) for the drug varies among the retail price and to certain government programs. Merck’s current retail price (Average Wholesale Price) for Isentress is $12,864 ppy—making it the most expensive of any antiretroviral recommended by HHS for therapy naive patients.. The price for the federally-funded, state-run and cash-strapped AIDS Drug Assistance Programs (ADAP) is $8,088 ppy—three times more expensive than commonly prescribed ARVs for therapy naive patients. Public programs (Federal and State) are the largest buyer of ARV medications with Medicare and Medicaid being the single largest payer in the U.S. for AIDS care.

At minimum, Isentress must be taken with at least two other HIV/AIDS drugs as part of an effective antiretroviral treatment regimen, pushing the overall price of one Isentress patient’s yearly AIDS drugs to between $20,000 and $30,000.

When Isentress was first introduced as a salvage therapy in 2007, Merck priced the drug at $9,900 ppy. At the time, AHF wrote to Merck to express alarm at the steep price of the drug and to ask that the company immediately lower the drug’s price. In October 2007, Margaret G. McGlynn, R Ph, Merck’s President for Global Vaccine and Infectious Diseases, responded to AHF’s concerns. In the letter, McGlynn listed Merck’ goals in establishing the price for Isentress, including:

• “Create broad patient access, including for patients who are covered by ADAP, Medicaid and private insurance" and "Generate an appropriate return on investment, based upon years of breakthrough research and the value Isentress brings to patients and healthcare providers, that will enable us to continue to pursue innovations through our research efforts"

Merck’s response also noted:

• "…at a Wholesale Acquisition Cost (WAC) of $27 per day, it [Isentress] is priced comparably with ritonavir-boosted protease inhibitors, the most frequently prescribed therapy for treatment experienced patients."

“In her October 2007 response to AHF, Ms. McGlynn states that Merck’s initial pricing of Isentress was in essence pegged or ‘priced comparably’ to those of other second line and salvage therapies. Now that Isentress has cleared FDA approval for first line use—a far larger market share—we are asking Merck to lower the price of Isentress in line with prices for other first line treatments for therapy naive patients,” added AHF’s Weinstein. “And we renew our challenge to Merck and the pharmaceutical industry as a whole to set pricing and access policies for these potentially lifesaving AIDS drugs in a manner that illustrates its concern for patient quality of life, rather than contributing to the public’s growing distrust in the pharmaceutical industry as a whole as a whole.”