AIDS Advocates, Health Officials Excited Over Pending Approval of T-20 But Worried That Cost May Be a Barrier for Many Patients
AIDS advocates and health officials are eagerly anticipating the pending approval of T-20, the first in a new class of AIDS drugs known as fusion inhibitors, hoping that the drug, which was designed to lower viral levels in patients whose HIV is resistant to one or more antiretroviral medications, will prolong life. However, they are concerned that the drug's predicted cost may be higher than many patients and state AIDS Drug Assistance Programs can afford, AP/Long Island Newsday reports. T-20, which will be marketed under the brand name Fuzeon by Roche and Trimeris Inc., has won a six-month priority review from the FDA, and company officials hope that the drug will be available to the public by the spring.
Roche and Trimeris have declined to discuss pricing of the drug until it is approved, but observers predict that a year's supply of T-20, which must be injected twice a day, will cost between $10,000 to $15,000 per patient. The most expensive single AIDS drug currently on the market costs about $7,500 a year per patient. The high price of T-20 is necessitated by its complicated manufacturing process, observers said. The drug is a "large, complex peptide, or string of amino acids." Two years ago Roche began building a plant to produce the drug. The plant is expected to be able to produce enough T-20 for 25,000 patients by the end of next year and 40,000 patients in 2004. However, with rising numbers of people with HIV experiencing drug resistance, observers predict demand could exceed supply. Even if enough of T-20 is available, "no one knows how they are going to afford" the drug, Bill Arnold, chair of the ADAP Working Group, an advocacy organization, said. Eleven states have either closed enrollment or limited services under their ADAPs because of budget shortfalls. Some activists are asking Roche and Trimeris for an "accounting of costs" for T-20, because they are concerned that the companies will keep prices high to garner large profits before similar oral drugs under development by Merck and Schering-Plough enter the market. Dani Bolognesi, one of the developers of the drug and a co-founder of Trimeris, said that concerns over price are "premature" because the company has not yet set a price. He noted that the drug may not raise the overall price of combination treatment "significantly" because it could replace one or more drugs in a patient's current drug regimen. Dr. James Thommes, medical director for T-20 at Roche, said that the price should be "kept in perspective" because the drug will prolong lives and lower hospital stays (Agovino, AP/Long Island Newsday, 8/22).