Merck Rewrites History on Pricing Top AIDS Drug, Isentress, Says AHF

Merck Rewrites History on Pricing Top AIDS Drug, Isentress, Says AHF
Drug Giant Tries to Dodge Reputation of Most Expensive First Line AIDS Therapy; 2009 Average Wholesale Price (AWP) of Merck's Isentress Remains at Top at Nearly $13K per Patient Yearly

LOS ANGELES--(BUSINESS WIRE)--The controversy around Merck and Co. Pharmaceuticals' pricing for its key AIDS drug Isentress - at nearly $13,000 per patient yearly, the most expensive first line AIDS therapy on the US market today - continued this week following Merck's reaction to recent public criticism of its AIDS drug pricing. Merck ramped up its damage control PR efforts, issuing a press release that sought to rewrite the history of Isentress and deflect attention by claiming AIDS Healthcare Foundation has been unfairly attacking them.

"Because of the difficult financial situation faced by state AIDS Drug Assistance Programs (ADAPs), in 2008 Merck announced a two-year price freeze to provide ISENTRESS at its launch price to ADAPs until December 31, 2010."
.In its press statement dated January 12, 2010, Merck officials claimed, "When ISENTRESS was approved, we established its price with the expectation that it would become first-line treatment," said Patrick Bergstedt, senior vice president and general manager, infectious diseases, Merck & Co., Inc. [bold added]

However, when it first introduced the drug to market two years ago, Merck described its expectations and pricing for Isentress as a salvage therapy, meaning treatment for a patient who has not responded to first-line therapy. In an October 25, 2007 response to AHF's 2007 pricing inquiry letter, Margaret McGlynn, President of Global Vaccines and Infectious Diseases, stated, "ISENTRESS provides unique value to patients and caregivers as the first integrase inhibitor, and at a wholesale acquisition cost (WAC) of $27 per day, it is priced comparably with ritonavir-boosted protease inhibitors, the most frequently prescribed therapy for treatment experienced HIV patients." [bold added] The phrase "treatment experienced HIV patients" is the term of art describing patients who need salvage therapy.

"The bottom line is that Isentress was initially approved by the FDA as a salvage therapy in 2007, has recently been FDA-approved for wider use as a first line treatment, but remains priced as if it were a salvage drug," said Michael Weinstein, President of AIDS Healthcare Foundation. "Despite Merck's efforts to spin it otherwise, the $12,868 annual price for Isentress - a single drug that must be taken with at least two other drugs - is the highest price of any first-line AIDS therapy in the US today."

In its press statement last week, Merck also claimed, "When ISENTRESS was approved in 2007, Merck priced ISENTRESS to be comparable to other antiretrovirals. At $29.85 per day, ISENTRESS is priced similarly to the protease inhibitors REYATAZ ($29.92 per day) and PREZISTA ($30.62 per day)."

However, Isentress is not priced comparably to other antiretroviral drugs (ARVs); it is priced comparably to other high-priced ARVs, like Bristol-Myers Squibb's Reyataz and Tibotec's Prezista. But unlike the other high-priced ARVs, Isentress attacks HIV in a different way that increases its desirability for use as a first-line treatment option. Isentress already has outpaced other high-priced ARVs in terms of sales. If Isentress was priced "responsibly" (as asserted by Merck in its press release and a San Francisco Chronicle print advertisement), then it would have been priced comparably to other frequently prescribed ARVs, such as Bristol-Myers Squibb's Sustiva and Gilead's Viread, both of which are half the price of Isentress.

In its press statement last week, Merck also asserted, "Because of the difficult financial situation faced by state AIDS Drug Assistance Programs (ADAPs), in 2008 Merck announced a two-year price freeze to provide ISENTRESS at its launch price to ADAPs until December 31, 2010."

However, what Merck conveniently omits from this seemingly altruistic claim is that Merck froze the price when Isentress was a salvage therapy. Now that it is a first-line therapy, Merck's price freeze effectively guarantees that for at least another year, Isentress will be priced higher than any other first-line HIV treatment.

Finally, Merck's press release attempts to shift the focus to AHF, claiming AHF is making "false accusations" against Merck. "It is obvious from their own words and actions that the only falsehoods are coming from Merck," responded Weinstein. "But let's be clear: AHF believes Isentress is a good drug that will serve some people very well. Our only interest in Merck right now is to ensure that they price Isentress at a level that is accessible to sick people and that does not bankrupt state AIDS drug assistance programs."

Merck's Isentress: Salvage Therapy versus First Line Use

Isentress was originally approved in October 2007 by the Food and Drug Administration (FDA) as a salvage therapy for treatment experienced patients who are resistant to other AIDS drugs. When it first came to market, Merck set the 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.

In July 2009, the FDA expanded its approval of Isentress for use as a first-line course of treatment of HIV/AIDS, meaning newly diagnosed, so-called treatment naïve patients who have never been on any AIDS drug regimens could also begin being prescribed the drug. This move vastly expands the US market for the Merck's Isentress and also makes the drug the most expensive first-line treatment available here.

By any of three benchmarks, the Average Wholesale Price, the Wholesale Acquisition Cost or the ADAP-Prime Vendor Price, Isentress is priced anywhere from $348 to $540 more per year than the second most expensive first-line AIDS treatment (Tibotec's Prezista) according to the most recent publicly available data.

Merck's current Average Wholesale Price for Isentress, $12,868 per patient per yearly, makes it the most expensive of any antiretroviral drug recommended by the U.S. Department of Health and Human Services (HHS) for first-line HIV/AIDS treatment. 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.

"The price of Isentress is putting an enormous strain on taxpayer funded State AIDS Drug Assistance Programs nationwide and the thousands of vulnerable HIV/AIDS patients who rely on them," said Jessie Gruttadauria, AHF Director of Public Affairs. "The limited funding available for ADAP is being exhausted by the high cost of Isentress and other newer, overpriced AIDS drugs. Several states are now unable to provide treatment to additional people who need it and are instituting waiting lists for ADAP enrollment while many existing ADAP clients are at risk for losing access to their lifesaving medications. We urge Merck now - as we did back in 2007 - to price Isentress fairly."

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 125,000 individuals in 23 countries worldwide in the US, Africa, Latin America/Caribbean the Asia/Pacific region and Eastern Europe.