A lifesaving antiviral drug used to treat a type of severe pneumonia in children and adults who have undergone bone marrow transplants can now cost more than the transplant itself after the drug’s sole distributor, Valeant Pharmaceuticals, increased the price by almost 400 percent.
Transplant specialists and pharmacists from MD Anderson Cancer Center in Houston; Duke University Medical Center in Durham, North Carolina; the University of Washington and Fred Hutchinson Cancer Research Center sounded the alarm about the price hike for aerosolized ribavirin, or Virazole, in a commentary published last week in the journal Transplant Infectious Diseases. The commentary was approved by infectious disease experts at Johns Hopkins, the Cleveland Clinic, Moffitt Cancer Center and Seattle Children’s Hospital.
The average wholesale price of aerosolized ribavirin went from an already costly $6,105 per day in January 2013 to a staggering $29,953 a day in September 2015, or $299,530 for a 10-day course. A stem cell transplant on average costs about $203,000, the commentary stated.
The dramatic price increase is “forcing patients and their providers to choose between their physical and financial well-being,” wrote the commentary’s authors.
The leap in price for aerosolized ribavirin follows previously reported drug price increases for other Valeant drugs, including heart drugs, a diabetes drug and a drug to treat a rare inherited disorder called Wilson disease, which have drawn the wrath of politicians and the public. The commentary is the first to report the price hike for aerosolized ribavirin.
“Where’s the outcry?” said Dr. Michael Boeckh, head of Fred Hutch’s Infectious Disease Sciences Program and one of the commentary’s five authors. “Often high drug prices are justified by research and development costs. But ribavirin is a very old drug. They are not launching any new studies or any expensive research programs in the area of respiratory virus disease. It seems totally arbitrary.”
Infections that pose little or no risk to people with healthy immune systems can be devastating for those who have undergone chemotherapy or radiation in advance of a hematopoietic stem cell transplant or are taking immunosuppressive drugs afterward. Aerosolized ribavirin is used to treat pneumonia caused by respiratory syncytial virus, or RSV, a highly contagious seasonal virus that studies show affects from 2 percent to 17 percent of transplant patients during the winter and spring seasons.
“It’s a relatively infrequent but very serious infection that can be fatal,” said Boeckh. “RSV can also cause outbreaks in cancer centers.”
Other patients at high risk of RSV disease include lung transplant recipients and people with blood cancers.
A lower-respiratory-tract RSV infection can be fatal 35 percent of the time for immune-compromised patients. Those with an RSV infection in their upper nose and sinuses are often treated with a week-long course of aerosolized ribavirin to prevent the infection from moving lower. Those with lower-tract infections require a 10-day treatment.
Aerosolized ribavirin is approved by the U.S. Food and Drug Administration for use in infants and children. Retrospective reviews and data analyses show that it’s also effective for adult stem transplant patients, as summarized in a recent paper on treating respiratory viral infections after transplantation published in the journal Blood. What’s more, there are presently no other drugs for treating severe RSV-caused pneumonia, said Boeckh, the senior author of the Blood paper, although new drugs are being tested in clinical trials.
Although ribavirin is available in oral form, giving it directly through respiratory tissues as aerosol has been the preferred way to administer the drug, and most study data are based on this form of administration. But due to the dramatic price increase, the commentary’s authors wrote, “Many cancer centers are now limiting the use of aerosolized ribavirin to all but the highest-risk patients or not using the drug at all.” Some cancer centers are substituting oral ribavirin, despite only limited data on its effectiveness.
“We strongly believe that the substitution of standard of care therapy solely in response to significant price escalations is highly detrimental to the patients we serve every day and may lead to worse outcomes, including death or serious morbidities in cancer patients and children across the country,” the letter’s authors wrote.
Boeckh said Seattle Cancer Care Alliance institutions will continue to use the aerosolized drug when needed.
“There are no good alternatives,” he said. “We feel that it is an important drug for our patients that we want to use when we feel that it’s needed.”
Because insurance covers a set amount for treatment, the added costs will have to be absorbed by hospitals or practice plans, he said.
RSV is a common cause of bronchiolitis, and Seattle Children’s sees about 20 to 60 children a week with the virus during the viral respiratory season, said Dr. Janet A. Englund, a physician-researcher and specialist in infectious diseases at Seattle Children’s Pediatric Infectious Disease Program and the University of Washington. Most don’t need treatment. Children at greatest risk of severe RSV infection include premature infants, children younger than 2 who were born with heart or lung disease, and babies and young children who have undergone bone marrow or stem cell transplants or other treatments and whose immune systems are weakened.
“Our bone marrow transplant children can have severe consequences, and they’re the ones we really need this for,” said Englund, who reviewed and approved the commentary in Transplant Infectious Diseases. “These are very vulnerable patients with no other alternatives. Without this, we don’t know what to do. We have no other drugs. We have no experimental drugs. Although we’re doing research on other drugs, the FDA won’t even let us try these drugs on children. For children, we have no other options, no alternative.”
Even before the recent price hike, aerosolized ribavirin was already both expensive and complicated to administer, Boeckh said. Patients must be hospitalized during treatment, adding to the costs. Hospital workers have to undergo specialized training to minimize exposure and wear respirator masks, and the drug is administered using hoods or tents in negative-pressure rooms with specialized ventilation.
Yet the price increase has nothing to do with supporting research to improve the drug’s effectiveness or make it easier to administer, he said.
“We are desperately in need of better RSV drugs because this is not an easy drug to give,” Boeckh said. “But until then, we have to have the option to give it when it’s needed.”
The increase in the cost of the anti-RSV treatment came on the heels of a much-publicized price increase by another drug company, Turing Pharmaceuticals. In September, it significantly increased the price of a drug used to treat a parasitic condition called toxoplasmosis to $750 a tablet from $13.50. Toxoplasmosis also affects people with compromised immune systems, including those with HIV and cancer.
Martin Shkreli, Turing’s chief executive officer, was indicted in December in the Federal District Court in Brooklyn on unrelated charges of securities fraud. Shkreli, who resigned from Turing, was subpoenaed to testify before the Full House Committee on Oversight and Government Reform in February. He invoked his Fifth Amendment right to not answer questions. The hearing focused on drug price increases by Turing and Valeant.
The price increases come in the context of rising concern over the high costs of new cancer drugs. More than 100 leading cancer experts from top treatment centers around the U.S. signed an editorial decrying the high costs of cancer drugs that was published last summer in the journal Mayo Clinical Proceedings. Six physician-scientists from Fred Hutch signed the editorial, including Dr. Gary Lyman, an internationally recognized oncologist and co-director of the Hutchinson Institute for Cancer Outcomes Research, or HICOR.
“Hopefully there will be strong and sustained pushback not only by patients and providers but by our political leadership,” Lyman said.
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Mary Engel is a former staff writer at Fred Hutchinson Cancer Research Center. Previously, she covered medicine and health policy for the Los Angeles Times, where she was part of a team that won a Pulitzer Prize for Public Service. She was also a fellow at the Knight Science Journalism Program at MIT. Follow her on Twitter @Engel140.