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Roche Sets European Price for New Antiretroviral Drug Fuzeon at More Than $20,000 Per Year
Roche has announced that its new antiretroviral drug Fuzeon, which is designed for HIV-positive patients who have failed to respond to other medications, will cost $20,385 per year in Europe, more than double the price of the most expensive AIDS treatments on the market, the Wall Street Journal reports. Roche said that the "extraordinarily difficult" manufacturing process, which requires 106 chemical reactions, more than 10 times the number for most other antiretroviral drugs, accounts for the "unusually high" cost of producing the drug, according to the Journal. The announcement -- which is an "unusual step," as the drug has not yet received marketing approval in the United States or Europe -- provides advance notice regarding the drug's cost to health care officials, AIDS drugs assistance programs and advocacy groups. The price reflects the cost to European markets that are under special drug-access programs, and the company is not expected to announce the U.S. market price until the drug receives FDA approval, which is expected to come next month, according to the Journal. The high price of Fuzeon has led ADAP programs in the United States to consider either not providing the drug or removing coverage of other drugs to free up the funds needed to cover the new drug. Because Fuzeon must be taken in combination with other antiretroviral drugs, the total price for a Fuzeon-containing regimen in the United States could range from $30,000 to $36,000 a year, although some doctors are exploring the possibility of supplanting other drugs to help lower the total cost. Michael Montgomery, chief of the Office of AIDS at the California Department of Health Services, estimated that 30% of the program's 25,000 patients could benefit from the drug but he said, "We just don't know if we'll have the money to pay for it" (Fuhrmans, Wall Street Journal, 2/24). Roche predicts that 3,500 people worldwide will be using the drug by the end of next month, including those people who are already involved in clinical trials and in an early free-access program; that number is expected to rise to between 12,000 and 15,000 people by the end of the year. Analysts said that demand is expected to surpass supply for the "foreseeable future" because as many as 50,000 patients could benefit from the drug, according to Reuters (Hirschler, Reuters, 2/24).
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