Trimeris, Roche Set Record $20,000 Price for Annual Supply of Fuzeon, Announce ‘Progressive Distribution Program’

Drug makers Roche and Trimeris yesterday announced that the price for their new antiretroviral drug Fuzeon will be "just shy" of $20,000 for a one-year supply, a "record price" but "in line" with the price previously set for the European market, the Raleigh News & Observer reports (Ranii, Raleigh News & Observer, 3/21). The FDA on March 13 approved the drug, which is designed for HIV/AIDS patients who have failed to respond to other medications and is the first drug in seven years that uses a new method to fight the virus. Fuzeon is in a new class of drugs called fusion inhibitors, which prevent the virus from entering cells by prohibiting the virus from attaching to cell membranes (Kaiser Daily HIV/AIDS Report, 3/18). Some advocates have said that the price of the drug is "too high" and could limit access for "those who really need it," the AP/Long Island Newsday reports (AP/Long Island Newsday, 3/20). Both Trimeris, the biotech company that developed the drug, and Roche, the Swiss pharmaceutical company producing and marketing the drug, said that the drug's complex, 106-step manufacturing process is to blame for its high price. Roche and Trimeris had projected that they would be able to supply the drug worldwide to between 12,000 and 15,000 patients this year and to approximately 32,000 by the end of 2004. About 10,000 of the patients receiving the drug in the first year of production will be in the United States (Kaiser Daily HIV/AIDS Report, 3/14). An advisory committee yesterday recommended that the European Union give marketing approval to Fuzeon; similar applications are still pending in Australia, Canada and Switzerland (Raleigh News & Observer, 3/21). Final European Union approval usually follows such recommendations within 90 days (Hirschler, Reuters, 3/20).

'Progressive Distribution'
Roche and Trimeris also announced yesterday a "Progressive Distribution Program" for the medication, which includes reimbursement assistance programs for patients who will not be able to afford Fuzeon's $20,000 annual price, according to a Roche/Trimeris release. Prescriptions will be distributed to physicians on a "first-come, first-serve basis," according to the release. "[S]everal" reimbursement programs for Fuzeon will be available for patients in need, and the company will work with the AIDS Drug Assistance Program to obtain inclusion and reimbursement for the drug (Roche/Trimeris release, 3/20). Trimeris spokesperson Robin Fastenau said that the plan was designed to get the drug to "as many patients as possible as quickly as possible" and to ensure that they have an "uninterrupted supply" once they start taking the medication. She added, "It's the most equitable solution to a difficult problem." Fastenau referred inquiries about eligibility to Roche spokesperson Carolyn Glynn, who said that the company will not disclose the eligibility criteria for its patient access program (Raleigh News & Observer, 3/21). The AIDS Healthcare Foundation yesterday criticized the high price of Fuzeon and encouraged state officials in California, New York and Florida to refuse to add the drug to Medicaid and ADAP formularies until Roche lowers the medication's price. "The exorbitant price of this new AIDS therapy Fuzeon has raised eyebrows among AIDS advocates, financial analysts and government officials and put the entire issue of AIDS drug pricing squarely under the microscope," Michael Weinstein, AHF president, said (AHF release, 3/20). Martin Delaney, founding director of Project Inform, said, "There is going to be some real social inequity in the way that it is distributed. It's a real mess" (Raleigh News & Observer, 3/21).