Should Medical Studies Include Cost Information?

That's the issued raised in an editorial in The New England Journal of Medicine, which praised a new study of a bloodthinner, but carped that there was a lack of information about the cost. In doing so, the editorial writers underscored the growing debate about the cost effectiveness of medicines and the extent to which this issue should play in treatment decisions.

To wit, the study of 3,002 people found that Arixtra, which is sold by GlaxoSmithKline for dealing with deep vein thrombosis and embolism, helped people with superficial-vein thrombosis in the legs. The condition worsened in 1.3 percent of those on a placebo for 45 days but just 0.2 percent of those on the med. The upshot: Arixtra prevented one in 88 patient froms having a more dangerous, but rarely fatal clot (see the abstract). But the study did not discuss price - the editorial writers canvassed four New York City pharmacies and found a 45-day regimen of 2.5 mg each day ranged from $2,124 to $7,380.

"Even at the lowest quoted price and considering the 98.3 percent estimated adherence rate, the cost of the treatment for 1,500 patients would be about $3.13 million. On the basis of the incremental one-year costs for medical care of a patient with a pulmonary embolus or deep-vein thrombosis, an estimated $250,000 or so in medical care costs would be averted, resulting in a net cost of treatment of about $2.88 million, or about $1,900 per treated patient, without any lives saved," the editorial states (go to the editorial section and look for 'Superficial Phlebitis and Phase 3.5 Trials).

“The paradox is, it’s effective, but for a condition that’s usually not considered an overwhelmingly serious medical problem,” Lee Goldman, dean of health sciences and medicine at Columbia University and one of the editorial writers, tells The New York Times. “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.” What to do? He wrote the FDA should give "serious thought" to mandating Phase 3.5 trials to document costs, the effects on quality of life, and cost-effectiveness of new treatments. And Atrixa, meanwhile, should not be used routinely.

A spokeswoman for the journal tells the Times that the study was published because it addresses an unmet medical need, while the editorial ran because it noted only one of 88 cases were helped by an expensive med. However, the lead author of the study, which was funded by Glaxo, tells the paper 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,” Hervé Decousushe tells the Times, noting that clots can be seen expaning 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...We don’t want to wait for a fatal pulmonary embolism.”