Fuzeon fury: price of first FDA-approved HIV fusion inhibitor sparks protest in US

Yesterday, the US Food and Drug Administration (FDA) approved the first HIV fusion inhibitor Fuzeon (enfuvirtide, also known as T-20), for use in combination with other anti-HIV medications to treat advanced HIV-1 infection in adults and children ages 6 years and older.

However, the drug’s anticipated U.S. price has sparked a war of words between the drug’s distributor, Roche, and US community activists. Roche have not yet released the actual U.S. price but said it will be close to the recently announced European annual cost of around £12,800 which is more than triple the cost of any other antiretroviral and 50% higher than the price predicted by financial analysts last summer (see news story)

The FDA based its approval of Fuzeon on an analysis of six months of data from one of two ongoing clinical studies of Fuzeon (TORO 1 and 2) involving approximately 1,000 patients. The New England Journal of Medicine (NEJM) yesterday posted the clinical results from the TORO 1 study on its web site, www.nejm.org, in advance of publishing the data in the May 29th issue.

The data from TORO 1 shows that the addition of Fuzeon to a combination of 3-5 optimised background antiretrovirals achieved more durable and larger reductions in HIV viral load than the background antiretrovirals alone (1.686 log₁₀ copies/ml vs 0.764 log₁₀ copies/ml) over 24 weeks, which was a highly significant difference. Increases in CD4 counts were also higher in the Fuzeon group (76 cells/mm³ vs 32 cells mm³). However, 98% of those on Fuzeon - which is self-injected subcutaneously twice daily - experienced injection site reactions, almost half of which required pain-alleviating treatment.

Whilst both the cost and the quality of life issues associated with the use of Fuzeon may affect both European approval, which is expected in May, and how the drug is used in the UK, US activists say that exorbitant price of Fuzeon will lead to chaos in the public health system. "Roche has priced Fuzeon at almost three times the price of the most expensive AIDS drug," said ACT UP/NY member Mark Milano. "This excessive price will force ADAP programs to cut other lifesaving drugs, restrict entry to their programs, or increase already long waiting lists. This will hasten the death of thousands of people with HIV in the U.S."

The AIDS Drug Assistance Programmes (ADAPs) - which pay for treatment for people with HIV who are un- or underinsured - are expected to experience a $140 million shortfall for this year unless new funds are available. Currently, ADAP programmes in 14 states are limiting enrolment or the drugs available on their formularies. ADAP directors are holding a series of meetings with pharmaceutical companies next week to negotiate discounts on all AIDS-related drugs, including Fuzeon, but it is doubtful these discounts will be enough to address the problem. "We don't think we can add Fuzeon (to our drug list) without cutting something else. We are excited about the drug, but we aren't sure we can afford it," Michael Montgomery, who oversees California's ADAP programme told the Associated Press (AP).

"Roche claims that Fuzeon is more expensive to produce than other anti-HIV drugs, but that doesn't justify this excessive price," says ACTUP/NY’s Eustacia Smith. "Roche claims it spent $600 million developing the drug, but they refuse to open their books to verify that. Our research suggests they spent closer to half that amount, and also that significant portions of the research costs were paid for by the NIH including the drug's discovery and the initial phase I clinical trial."

Fuzeon's manufacture is very complicated, requiring three times the normal number of ingredients and four times the average number of processing steps. Initially, only 12,000 to 15,000 patients world-wide will have access to Fuzeon due to production constraints. Roche's chairman and chief executive, Franz Humer, told the AP: "We need to make a decent rate of return on our innovations. This is a major breakthrough therapy. I can't imagine a society that doesn't want that innovation to continue."