Biotech Values

[DewDiligence]

NEJM Editorial Challenges Use of Arixtra for SVT

[SVT = Superficial Vein Thrombosis, a less serious condition than DVT that is generally not treated at all.]

http://www.nytimes.com/2010/09/23/business/23drug.html

›September 23, 2010
By DUFF WILSON

An editorial in The New England Journal of Medicine on Wednesday took the unusual position of challenging a study published in the same issue.

The exchange highlighted a growing debate in American medicine: how much should health care providers pay for expensive treatments that make relatively small improvements?

The published study proved that a blood-thinning medicine could prevent problems from worsening in some people with a sometimes painful, usually short-term, blood clot near the surface of the leg, called superficial-vein thrombosis.

But the editorial challenged the unreported cost of the treatment in the study — more than $180,000 for 88 patients to receive injections for 45 days — to prevent one of them from having a more dangerous, but rarely fatal, deep vein clot.

The issue of cost-effectiveness is taking on new importance as more Americans become eligible for Medicare insurance, and some 30 million uninsured people are promised health coverage by 2019.

The United States already spends more on health care than any other country, yet it does less than many countries to control the costs. That has also been an issue with biologic drugs — some that can cost $100,000 a year — that prolong life in late-stage cancer patients, as well as some expensive medical devices for heart patients.

Dr. Stephen Resch, deputy director of the Center for Health Decision Science at the Harvard School of Public Health, said, “My feeling is resources are limited, and you have to ration care somehow because all of our money can’t be spent on health care.”

Last year, Congress backed away from plans to limit health care spending after opponents claimed it would lead to so-called death panels. Lawmakers have also declined to give Medicare the authority to negotiate lower prices directly with drug makers.

Congress did, however, authorize a Patient-Centered Outcomes Research Institute that can do cost-effectiveness studies and an Independent Medicare Advisory Board that could eventually press for lower prices.

The reports on the blood thinner pitted Dr. Lee Goldman, dean of health sciences and medicine at Columbia and a critic of higher costs, against a team of European researchers financed by the drug maker GlaxoSmithKline.

The study of 3,002 people with superficial-vein thrombosis showed that the condition worsened to deep vein thrombosis or pulmonary embolism in 1.3 percent of those who took a placebo for 45 days and 0.2 percent of those who took the drug Arixtra.

It was an excellent, randomized, double-blind study that reported statistically significant results, Dr. Goldman and Dr. Jeffrey S. Ginsberg, a blood expert, wrote in the editorial.

But the study did not talk about the costs, they wrote, which could range from $2,124 to $7,380 a person for 45 days of injections, or at least $186,000 for 88 people to avoid one new problem.

“The paradox is, it’s effective, but for a condition that’s usually not considered an overwhelmingly serious medical problem,” Dr. Goldman said in an interview. “The fact that it’s a medicine that’s expensive really raises an issue, not just for this trial, but we tried to make the point more broadly.”

Cost-effectiveness researchers in America have benchmarks that suggest that “good value for the money” is $50,000 per added year of high-quality life, Dr. Resch said. In some cases, where cheaper treatments are unavailable, up to $120,000 per added year have been suggested, he said.

The editorial did not analyze long-term outcomes. Dr. Resch, who was not involved in either article, said it appeared the cost would not provide that value.

But the drug is nearing approval for shallow-vein use in Europe, where costs are considered by regulators. GlaxoSmithKline is not seeking such approval by the Food and Drug Administration, which considers only safety and efficacy.

The F.D.A. has already approved the drug to treat and prevent deep vein thrombosis and embolism. Sarah Alspach, a spokeswoman for GlaxoSmithKline, said the price of Arixtra was a good value for those conditions. She said the company would discuss pricing for the new treatment with individual countries in Europe.

Karen P. Buckley, spokeswoman for the journal, said it published the study because it addresses an unmet medical need, and it published the editorial to point out the high cost of treatment to help one in 88 cases.

Dr. Hervé Decousus, lead author of the study, said he thought that the editorial was unfair.

“If we give this drug, we avoid a great number of surgical procedures, which are risky for patients and cost a lot of money,” he said in a telephone interview from Saint-Étienne, France.

Further, he said, patients and doctors can see clots expand in the veins under skin toward deeper veins where they can also migrate to the lungs.

“It’s painful, and you can see the clot in front of you,” he said. “Patients are frightened; physicians are frightened. We don’t want to wait for a fatal pulmonary embolism.”‹