Price criticized for new anti-HIV drug
The FDA’s accelerated approval of Fuzeon (enfuvirtide) for use in combination with other anti-HIV medications has drawn mixed reactions: excitement that a new class of drugs is now on the market and disappointment that its manufacturer, Trimeris, has priced the drug so high.
Fuzeon is the first product in a new class of medications, called fusion inhibitors, to receive marketing approval. Drugs in this class interfere with the entry of HIV-1 into cells by inhibiting the fusion of viral and cellular membranes. This inhibition blocks the virus’ ability to infect certain components of the immune system. It will be used mainly as salvage therapy in patients who have failed other drugs because of resistance.
"Fuzeon adds an important dimension to our armamentarium of anti-HIV treatments. By affecting viral spread in a different way from existing medications, it helps reduce viral loads, which has been shown to slow HIV progression in patients who have developed resistance to currently available medications," said Commissioner of Food and Drugs Mark B. McClellan, MD, PhD.
Michael Saag, MD, director of the AIDS Outpatient Clinic at the University of Alabama, notes that patients are becoming resistant to the best therapies and need new options. "This drug attacks the virus in a new way, so it can work for patients whose virus is resistant to other therapies," he says.
The FDA based its accelerated approval of Fuzeon on an analysis of six months of data from two ongoing clinical studies of Fuzeon involving approximately 1,000 patients. The data showed that the addition of Fuzeon to a combination of other anti-HIV medications reduced HIV viral load in the blood more than the use of the combination of anti-HIV medications alone. The long-term effects of Fuzeon are not known at this time, but are being evaluated by the ongoing clinical studies.
Because of the FDA’s approval, the study, T-20 vs. Optimized Regimen Only Study 1 (TORO 1), was published early in an on-line version of the New England Journal of Medicine.1 It concluded that adding Fuzeon to an existing "optimized" antiretroviral regimen "provided significant antiretroviral and immunologic benefit through 24 weeks" in participants who had previously received multiple antiretroviral drugs and who had multidrug-resistant HIV.
Trimeris, the biotech company that developed Fuzeon, and Roche, the Swiss pharmaceutical company producing and marketing the drug, expect to begin shipping Fuzeon by early April. But already, activists are protesting the high cost of the drug, set at $20,500 per year. ACT-UP New York, for example, has staged a demonstration at Roche’s headquarters in New Jersey.
"There’s no guarantee, perhaps not even a likelihood, that most of the people who truly need this drug will be in a position to get it," says Martin Delaney, founding director of Project Inform. "The AIDS Drug Assistance Program [ADAP] is facing a financial crisis without even considering the addition of Fuzeon, and the cost of the drug will be a hard blow to already strapped Medicaid budgets."
Despite assurances from Trimeris that new rebates for the drug will be given to ADAPs, the drug will likely remain out of reach. Ryan Clary, senior policy advocate for Project Inform, says "For many state ADAP programs, the only option may be to take other drugs off the formulary or make other major changes to the program if they really hope to add Fuzeon. This would pit one set of patient needs against another’s."
It is estimated that half of the $60 million in additional federal ADAP money for anti-HIV medications in FY2002 was spent to cover price increases alone. Trimeris and Roche have both defended the pricing, noting that the drug has cost more than other FDA-approved anti-HIV drugs and that manufacturing is extremely complex.
With extensive data in the past year showing dramatic rises of HIV drug resistance, Fuzeon could be in great demand. Yet because of the lengthy manufacturing process, Roche anticipates that currently it will only be able to fill prescriptions for about 3,000 patients.
"We are fully in line with our manufacturing schedule despite the extraordinary challenges that Fuzeon production has posed," says William M. Burns, president of Roche Pharmaceuticals.
Reference
1. Lalezari JP, Henry K, O’Hearn M, et al. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med 2003; Mar 13 (e-pub ahead of print).
The FDAs accelerated approval of Fuzeon (enfuvirtide) for use in combination with other anti-HIV medications has drawn mixed reactions: excitement that a new class of drugs is now on the market and disappointment that its manufacturer, Trimeris, has priced the drug so high.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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