First came euphoria as AIDS advocates in California and elsewhere welcomed a new drug approved to treat patients with advanced stages of the disease. Now comes dismay at its expected annual price tag of $20,000.
"This is a bittersweet moment," said Daniel Montoya of AIDS Project Los Angeles. "For people who have no other hope but these drugs, they provide a great amount of promise." But the price, he said, is prohibitive.
Fuzeon, approved Thursday by the U.S. Food and Drug Administration, is the first in a new class of drugs called fusion inhibitors, which block the virus' ability to infect components of the immune system. Experts estimate that about 10% of HIV and AIDS patients have virus strains that are resistant to current drug regimens and could benefit from taking Fuzeon.
The U.S. price for the drug has yet to be officially determined, but its distributor, Roche Pharmaceuticals, has said it will be close to the European price of $20,409 per year.
California health officials said Friday that Fuzeon represents the greatest financial challenge to the state's AIDS Drug Assistance Program since the introduction of protease inhibitors and combination therapy in 1995-96. At that time, the cost for many patients doubled while some patients' drug costs jumped as much as fivefold.
"With the current budget restraints, we're concerned that [the drug assistance program] doesn't have sufficient funding to continue our existing level of services," said Michael Montgomery, director of the state office of AIDS. "Adding a highly expensive drug is problematic."
Ged Kenslea of the AIDS Healthcare Foundation in Los Angeles said: "We all expected the drug was going to come in at $14,000 or $15,000. But $20,000? That's a big jump up."
At the New York-based AIDS Treatment Data Network, officials feel betrayed.
Lei Chou, director of the network's access project, said he and other AIDS advocates have held extensive discussions with Roche officials, visited the Boulder, Colo., plant where Fuzeon is manufactured and attended a company presentation on the drug.
The company, he said, went to great lengths "to convince the community that they're willing to work with us, telling us how they were intending to price this drug as part of a whole chain of research instead of wanting to recoup their investment on this drug alone. Now we see it's about dollars."
Roche spokeswoman Heather Van Ness said the company wants everyone who needs Fuzeon to have access to it and emphasized that the $20,000 price reflects the 10 years it took to develop the drug and the $600 million spent on research, clinical trials, manufacturing and other expenses.
Beatriz Diaz, 47, has participated in the clinical trials of Fuzeon for two years and credits Fuzeon with keeping her alive.
For the previous nine years, the Fresno mother of four said she had tried numerous drugs but her viral load rose higher and higher while her immune system continued to weaken. Two shots a day of Fuzeon, along with other medications, have lowered the virus to undetectable levels.
"I'm feeling good and ready to go back to work," Diaz said. "I tell people there is hope."
The FDA approved Fuzeon on an accelerated schedule because it is the first in its class. Fuzeon is administered as a subcutaneous injection and the drug can cause serious allergic reactions and local skin reactions at the site of injection.
The FDA has warned doctors to carefully monitor patients for signs of pneumonia.
Since AZT gained FDA approval and offered some hope in the fight against HIV, new AIDS drugs historically have been expensive. When it first was marketed, AZT cost about $10,000 a year, said Martin Delaney of the advocacy group Project Inform in San Francisco, but community outrage helped bring down the price.
"Back in those days, people stormed the FDA building, there was a disruption at the New York stock market, and there were efforts to embarrass [its maker] internationally," he said.
Fuzeon is different. "This is a tough one because in the past, high prices clearly have been attributable to greed," Delaney said. "This is the first time I think there really is a reasonable case for why it's more expensive."
Montgomery, of California's AIDS drug program, and officials from five other states are traveling to Washington for a meeting Monday with Roche to discuss the drug's cost.
About 25,000 people are enrolled in the state's AIDS Drug Assistance Program, which covers all AIDS medication for patients who earn less than $50,000 per year; those earning more than about $35,540 per year must pay some of the cost.
In order to add Fuzeon to the program's registry, Montgomery said, the state may have to remove other drugs or be very restrictive about who has access to it.
"I don't anticipate that we will get the additional funding we will need to add it without taking some other steps to control our expenditures" for the drug program, Montgomery said. "I don't see an easy solution."