A year after launching the first drug in the fusion inhibitor class of anti-HIV medications, drugmaker Roche says it has overcome shortages of its hard-to-manufacture drug and is making it widely available. Fuzeon, which costs more than $20,000 a year, will be widely available starting April 26 at retail and specialty pharmacies nationwide, the Nutley, N.J.-based drugmaker said Wednesday. In addition, more state AIDS Drug Assistance Programs are now covering the drug--37, up from 19 last July. Medicaid and most private insurers already cover it. Unlike other anti-HIV drugs, Fuzeon blocks the virus from entering immune cells. But because of the medication's cost and the need for patients to inject it twice a day, Fuzeon is generally prescribed only when other AIDS medicines no longer work.
Jules Levin, executive director of the National AIDS Treatment Advocacy Project, says Fuzeon's use has been limited by its cost and a preponderance of doctors who doubt that many patients could handle the injections and the swelling, tenderness, and nodules that sometimes develop at injection sites. No other side effects are common. Roche initially limited access because of a difficulty in manufacturing the complex compound. The drugmaker wanted to ensure that patients starting on Fuzeon could keep getting it because missing medication doses makes it easier for HIV to grow resistant to the drugs. Previously, doctors had to send a special order for Fuzeon to a single specialty pharmacy company, which mailed it back after determining an insurer would pay for the drug. Roche spokeswoman Pamela Van Houton says the company has expanded manufacturing capacity, so doctors now can write a prescription for patients to be filled at any pharmacy.
Fuzeon's high cost is due to its complexity, the company says. Production involves 44 different raw materials and more than 100 manufacturing steps and takes about six months to complete.