October 15, 2007
San Francisco, CA -- Project Inform, one of the nation's best known HIV treatment and health care information and advocacy organizations, today expressed mixed reaction to the price announced for Isentress (raltegravir), a new anti-HIV drug from Merck approved on Friday by the FDA. While Project Inform enthusiastically supports the Food and Drug Administration's (FDA) approval of this important new drug, Merck's decision to price drug at $27 per day was a mild disappointment.
Isentress will initially be used in the treatment of people with advanced HIV disease who are resistant to most other therapies. The FDA's decision to approve Isentress was based primarily on results from two pivotal studies, named BENCHMRK 1 and 2. These studies compared Isentress to a placebo, both combined with the best available combination of anti-HIV drugs -- called optimized background therapy. After 24 weeks, approximately 75% taking Isentress had HIV levels below the limit of detection, compared to around 40% of people taking the placebo. Rates of side effects were similar between the people taking Isentress and those taking placebo, suggesting that Isentress should be well tolerated.
According to Martin Delaney, Project Inform's Founding Director, "Isentress might be the most potent HIV drug yet developed. Its approval marks a real advance for people battling drug-resistant HIV." Paul Dalton, also of Project Inform, added, "While it takes real-world use to fully understand any new drug, Isentress has met even the highest expectations in all clinical trials to date."
Attention now turns to ensuring the widest possible access to this vital new treatment option. Anne Donnelley, Director of Health Care Policy for Project Inform said, "We call on all public payers, including the AIDS Drugs Assistance Programs, Medicare Part D and Medicaid to add Isentress to their formularies as quickly as possible."
The approval of Isentress comes at an exciting time for people living with HIV, particularly those with difficult to treat, drug resistant HIV. Along with the recent approvals of Prezista (darunavir) and Selzentry (maraviroc) as well as the anticipated approval of etravirine in early 2008, most people, even with extensive treatment experience and multiple class drug resistance can put together a potent drug regimen capable of fully suppressing HIV replication.
Merck still has an opportunity to be a better corporate citizen. Project Inform calls for Merck to freeze the price of Isentress for three years and to commit to lowering the price if the FDA grants Isentress approval for first line use in people just beginning treatment. Price reductions are often granted in Europe when a drug is approved for wider use than at its initial approval. The price freeze would ensure federal and private payers could have price stability for a number of years, making it easier to plan and budget. The roll back would come along with a greatly expanded potential market, opening up access for many more people. Project Inform, along with our community partners will work with Merck to ensure that this vital new drug is available to all who need it.