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Merck responds to AHF: Merck Provides Accurate Information about the Pricing of ISENTRESS® (raltegravir)
 
 
 
 
For immediate release

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WHITEHOUSE STATION, N.J., January 12, 2010 - In response to false accusations being made by the AIDS Healthcare Foundation (AHF), Merck today provided accurate information about the pricing of ISENTRESS® (raltegravir) tablets. Merck has been at the forefront of responding to the HIV and AIDS crisis since we began our HIV research program 25 years ago, and has invested billions of dollars towards developing medicines and vaccines for HIV.
 
"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. "The price of ISENTRESS was determined after consultation with respected leaders in the HIV community, and in line with Merck's long-standing commitment to ensure access to our medicines."
 
ISENTRESS is the first HIV integrase inhibitor, and is the result of research that started in 1993. 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).*
 
In addition to pricing ISENTRESS responsibly, Merck has taken a number of other actions to help patients who use our HIV medications:
 
· 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.
 
· Merck also provides reimbursement support and free drug for uninsured patients through its SUPPORTª Program. Since its inception in 1996, the SUPPORT Program has assisted more than 23,000 patients nationally.
 
· In 2009, Merck introduced a co-pay assistance program for eligible patients on ISENTRESS who have commercial insurance and have co-pays or coinsurance between $30 and $400 per month.
 
Merck's engagement with the HIV community has benefitted from an open, collaborative and positive relationship with HIV community leaders around the world. The grade Merck received in 2009 from the AIDS Treatment Activities Coalition (ATAC), one of the most representative and respected coalitions of HIV community groups in the U.S., is a better indicator of the work that we do in this area than AHF's campaign. ATAC gave Merck the highest grade in the industry ("B") based in part on high marks for Merck's pricing practices and for its sustained collaboration with the HIV community.
 
While Merck agrees with the overall goals of AHF to provide access to HIV care and to provide medicines to people living with HIV, we disagree with the statements and actions of the AHF regarding ISENTRESS. We sincerely hope that AHF will recognize that Merck continues to act responsibly in its work in HIV, and that AHF will curtail this campaign of misinformation.
 
*Referenced prices are derived from published price lists and do not necessarily reflect actual prices paid by consumers to dispensers.
 
Lower acquisition costs alone do not necessarily reflect a cost advantage in the outcome of the condition treated because there are other variables that affect relative costs.
 
The products referred to in this price comparison are not known to have comparable efficacy.
 
Important information about ISENTRESS
ISENTRESS is indicated in combination with other ARV agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients. This indication is based on analyses of plasma HIV-1 RNA levels up through 48 weeks in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class AVR (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naive adults. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatments response.
 
The safety and efficacy of ISENTRESS have not been established in pediatric patients.
 
Important safety information about ISENTRESS
ISENTRESS does not cure HIV or AIDS and does not prevent passing HIV to others. Healthcare providers should know that immune reconstitution syndrome has been reported in patients treated with ARV therapy, which may necessitate further evaluation and treatment.
 
Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported, however the relationship of ISENTRESS to these events is not known. ISENTRESS should be used with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medication known to cause these conditions.
 
Tolerability profile of ISENTRESS
In treatment-na•ve patients receiving ISENTRESS, the most commonly (greater than or equal to two percent in either treatment group) reported drug-related clinical adverse event (AE) of moderate or severe intensity and at a higher incidence compared to efavirenz was insomnia (4 percent vs. 3 percent). In treatment-experienced patients receiving ISENTRESS, the most commonly (greater than or equal to 2 percent in either treatment group) reported drug-related clinical AEs of moderate or severe intensity in treatment-experienced patients receiving ISENTRESS and at a higher rate compared to placebo were headache (rate of three vs. one, per 100 patient years), nausea (rate of two vs. one, per 100 patient years), asthenia/weakness (rate of two vs. one, per 100 patient years) and fatigue (rate of two vs. one, per 100 patient years).
 
Dosing and administration
ISENTRESS is a single 400 mg tablet taken twice daily without regard to food. The dose of ISENTRESS should be increased during coadmistration with rifampin to 800 mg twice daily.
 
Drug interactions
Coadmistration with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may reduce plasma concentrations of ISENTRESS. Based on the results of drug interaction studies and the clinical trials data, no dose adjustment of ISENTRESS is required when co administered with other ARV agents. Also, preclinical studies show that ISENTRESS is not metabolized by cytochrome P450 enzymes.
 
About Merck
Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com.
 
Forward-looking statement
 
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's and Schering-Plough's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
 
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.
 
Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended Sept. 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).
 

ISENTRESS® is a registered trademark of Merck & Co., Inc.
 
 
 
 
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