AHF to protest Merck’s Isentress pricing and policies at CROI

AIDS Healthcare Foundation (AHF):

“Now that it has been approved for first-line treatment, there is no justification for Merck to price Isentress three times higher than other first-line AIDS drugs”

VISUALS:

• 3ft x 5ft “Shame on Merck” placards & banners
• Several 3ft x 4ft sandwich board ads parodying a full page, 4 color print ad Merck published in the SF Chronicle during a January 12, 2010 S.F. protest defending its AIDS drug pricing and policies
• 1,000 flyers of AHF’s Merck parody ad will be also distributed to conference attendees

AIDS Healthcare Foundation (AHF) will host a protest Wednesday morning, February 17 at 8:00am targeting Merck and Co. Pharmaceuticals over the pricing and policies for its key HIV/AIDS drug, Isentress, the most expensive first-line AIDS treatment in the US, during the 17^th Conference of Retroviruses and Opportunistic Infections (CROI) in San Francisco. The protest will take place in front of Moscone Center WEST (4^th and Howard Streets), where CROI is meeting. The protest is scheduled to occur in advance of presentation of a research paper by Merck scientists Wednesday morning during the conference. The Merck presentation is on the drug, vicriviroc, an experimental HIV salvage treatment. In late January, Merck announced it wouldn't seek U.S. regulatory approval for the drug because the drug didn't meet its primary treatment efficacy goal in two late-stage studies.

“Now that it has been approved for first-line treatment, there is no justification for Merck to price Isentress three times higher than other first-line AIDS drugs,” said Michael Weinstein, AIDS Healthcare Foundation President, in a statement. “The price of this drug is putting an unbearable strain on taxpayer funded State AIDS Drug Assistance Programs (ADAP) and the thousands of people who rely on them. The limited funding available for these programs is being exhausted by the high cost of Isentress and other newer AIDS drugs. Several states are now unable to provide treatment to additional people who need it. Through this protest at CROI, we reiterate our call on Merck to do the right thing and immediately lower the price of Isentress.”

AHF protestors will carry signs and banners stating, “Shame on Merck” at the 4^th and Howard Street entrance to Moscone Center WEST, during the company’s presentation at the Retrovirus Conference. In addition, protesters will carry several three-foot by four-foot sandwich board advertisements parodying a defensive full page, four color print ad that Merck published last month in the San Francisco Chronicle (Tuesday, January 12, 2010, page A5) defending its AIDS drug pricing and policies. Merck published that ad during a similar protest spearheaded by AHF that took place last month during the J.P. Morgan Healthcare Investor Conference (also in San Francisco) at the Westin St. Francis Hotel. In response to Merck’s ad, AHF advocates created a point-by-point parody advertisement refuting almost every claim made by Merck in its initial Chronicle ad. Protesters will hand out 1,000 copies of the ad to CROI attendees, and AHF’s parody ad will also be published in select newspapers and magazines nationwide.

“We’re here to let people know that Merck is causing great harm to people with HIV/AIDS with its unwarranted pricing of Isentress,” said Adam Ouderkirk, Region Manager/Bay Area, for AIDS Healthcare Foundation. “Programs like ADAP are feeling the impact right now and lives are being put at risk because of excessive drug pricing. Some of California and the nation’s most vulnerable citizens may face a potentially fatal interruption in their lifesaving treatment. This cannot continue. Merck should lower the price of Isentress immediately.”

Background on AHF Advocacy on Merck’s Drug Pricing

AHF’s Merck protest at CROI is part of an ongoing advocacy campaign targeting Merck over its pricing for Isentress. Earlier this week, innovative vinyl train station banner ads urging, ‘Merck: ‘Do the Right Thing’ were hung from light poles on the train platforms in Whitehouse Station, NJ, Merck’s hometown in an effort to educate Merck employees and other commuters about Merck’s AIDS drug pricing and policies. This protest comes on the heels of a similar protest targeting Merck held in early January in San Francisco in conjunction with the J.P. Morgan Investor Healthcare Conference, where Merck officials were speaking. Perhaps expecting a protest or action, Merck placed a somewhat defensive full page, four color print ad in that day’s issue of the San Francisco Chronicle (Tuesday January 12, 2010, page A5). The ad touted Merck’s, “…commitment to HIV and AIDS,” and claimed, “We price all our HIV medicines fairly and responsibly.”

The Whitehouse Station banner ad campaign also follows an inquiry into Merck’s pricing strategy for Isentress by the California Public Employees Retirement System (CalPERS), the nation’s largest public pension fund. In December, advocates from AHF testified before members of the CalPERS Investment Committee about the impact of the high price of the drug on people with AIDS in California and across the country. In response to AHF’s testimony, the committee agreed to make an inquiry.

AHF also wrote 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. NOTE: The price for many of 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 first-line treatment).

In addition, AHF also sent postcard mailers last summer to homes in select zip codes in and around Merck’s headquarters in an effort to inform Merck employees about the company’s pricing and policies regarding Isentress.

Merck’s Isentress: Salvage Therapy versus First Line Use

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. When it first came to market, Merck set the Average Wholesale Price (AWP) of Isentress at $12,150 per patient yearly. Merck has since raised the AWP of Isentress to $12,868—a 5% price hike—since its introduction to market two years ago.

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.

The Department of Health and Human Services treatment guidelines include several preferred treatment 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.

Merck released its 4^th quarter 2009 earnings earlier today, February 16, 2010. Isentress has now exceeded $1 billion ($1.13 billion) in total sales (U.S. and Int’l combined). Isentress was approved for market in October 2007, so this is roughly $1 billion in sales in 2 years.