Officials from drugmakers Roche and Trimeris announced Thursday that the U.S. price for their newly approved HIV entry inhibitor Fuzeon will be just under $20,000 per year, making the drug the most expensive HIV medication on the market. The Food and Drug Administration approved the drug, the first of its kind that works by preventing HIV from entering immune system cells, on March 13. Trimeris and Roche officials say that the drug's complex 106-step manufacturing process is to blame for its high price. They estimate that because the drug is so difficult to manufacture, the company will be able to provide Fuzeon to only between 12,000 and 15,000 patients worldwide by the end of the year. About 10,000 of those patients will be Americans.
Company officials on Thursday also announced a "Progressive Distribution Program" for the medication, which includes reimbursement assistance programs for patients who can't pay Fuzeon's $20,000 annual price tag. "Several 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," said a Roche-Trimeris press release, although specific details about the program were not provided.
Fuzeon will be available by prescription on a first-come, first-serve basis. "It's the most equitable solution to a difficult problem," said Trimeris spokeswoman Robin Fastenau.