Criminal pricing of Merck’s HIV/AIDS drug Isentress challenged by the AIDS Healthcare Foundation

Sep 3 2009

As part of its ongoing campaign to lower drug prices and increase access, AIDS Healthcare Foundation (AHF) today unveiled its latest advocacy campaign challenging Merck and Co. Pharmaceuticals over the steep price of its key HIV/AIDS drug, Isentress (raltegravir). The first phase of the public awareness campaign includes a postcard mailer, scheduled to arrive this week in the mailboxes of residents of Whitehouse Station, New Jersey, where Merck is headquartered. The front of the postcard features a mock “Wanted” poster with an artist rendering of Merck CEO Richard T. Clark pictured beneath the headline: “WANTED: Criminal AIDS Drug Pricing.”

The back of the postcard explains: “Richard T. Clark, CEO of Merck & Co. Pharmaceuticals, is wanted for pricing Merck’s HIV/AIDS drug Isentress so high that it is now the most expensive first-line HIV/AIDS drug. Recently approved by the FDA as a first-line treatment, Isentress is up to three times more expensive than other first-line treatments—as much as $12,864 per patient per year. This criminal pricing threatens to limit the ability of Medicaid and AIDS Drug Assistance programs nationwide to provide crucial lifesaving drugs to its patients.”

“It is criminal for Merck to have priced its newest HIV/AIDS drug, Isentress at an astronomical $12,864 per patient per year—especially now that the FDA has approved the drug for first-line use, vastly increasing the drug’s market,” said Michael Weinstein, AIDS Healthcare Foundation President. “AHF has repeatedly requested that Merck lower the price of Isentress so that more patients will be able to access it. Merck has refused to do so. Cash-strapped ADAP and Medicaid programs will go bankrupt if these government programs—and the taxpayers who fund them—are forced to continue subsidizing the cost of new medicines like Isentress that are priced unjustifiably high.”

Initially approved in October 2007 by the Food and Drug Administration (FDA) as a salvage therapy, the FDA recently expanded its approval of Merck’s Isentress 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 on the market.

Merck’s current retail price (Average Wholesale Price) for Isentress is $12,864 per patient per year—making it the most expensive of any antiretroviral (ARV) recommended by the U.S. Department of Health and Human Services (HHS) for therapy naive patients. The price for the federally-funded, state-run and cash-strapped AIDS Drug Assistance Programs (ADAP) is $8,088 per patient per year—three times more expensive than commonly prescribed ARVs for therapy naive patients.

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. Public programs (Federal and State) are the largest purchaser of ARV medications in the country, with Medicare and Medicaid the single largest payer for HIV/AIDS care in the U.S.

In addition to the postcard mailer campaign, AHF has also written letters to all state ADAP and Medicaid Directors requesting that Isentress be placed on “prior authorization” in order to control costs while still ensuring that those patients who need Isentress have access to it. Placing “prior authorization” procedures on Isentress ensures that the drug remains available to those for whom it is medically necessary. The procedure simply requires that a physician fill out a request form if he/she deems it necessary to prescribe the drug.

The letter, signed by Mr. Weinstein, states:

“Isentress was originally approved as salvage therapy, and priced accordingly. Just recently it was approved for patients starting AIDS treatment for the first time (so-called first-line treatment). However, the price has not dropped. At a price of $12,860 per patient per year, Isentress is the single most expensive treatment approved for first-line use.

This high price will put a strain on ADAPs and Medicaid programs, which is not necessary. Isentress should only be prescribed to patients when there is a documented need for it.

The Department of Health and Human Services treatment guidelines include several preferred options for first-line patients. These options provide the same clinical benefit as Isentress but cost less. For example, Isentress – which must be taken with two additional AIDS drugs – costs nearly as much as an entire three-drug regimen of Viread, Emtriva and Sustiva.”