Some health insurers, concerned that participation in a clinical trial drives up the cost of cancer care, decline coverage to patients enrolled in cancer trials. However, the results of a study by Thomas N. Chirikos, Ph.D. and others at the H. Lee Moffitt Cancer Center in Tampa, Florida, offer no basis for such a policy.
The study, which was published in the April 2001 issue of the journal Medical Care, supports findings from previous research showing that cancer patients enrolled in clinical trials incur no significant increase in treatment costs.
Participants in cancer treatment trials “do not receive more, nor more expensive, services than similarly situated patients who do not enter trials,” the researchers concluded. The researchers controlled for variables such as age, extent of disease, initial treatment, and ultimate outcome so as to identify cost differences between the in-trial and out-of-trial patients that were due to trial participation alone.
Isolating the Effect of Trial Participation
Chirikos and his colleagues examined hospital billing records for about 1,900 cancer patients who were diagnosed and treated at the Moffitt Cancer Center between August 1995 and February 1998. About 380 of these patients were enrolled in clinical trials of cancer treatment. Most of the patients studied were treated for breast cancer; the others, for lung cancer, ovarian cancer, or lymphoma.
The researchers looked for differences in the costs of care given to patients who took part in clinical trials compared with patients with the same type of cancer who did not enroll in trials. They also analyzed differences among patients that could affect the cost of care, such as age, stage of disease, initial treatment received, and treatment outcome. Finally, they used statistical techniques to adjust for such variation among patients in order to isolate cost increases that could be tied only to participation in a clinical trial.
Unadjusted costs did indeed tend to be higher for patients enrolled in trials. The investigators found that patients enrolled in trials tended to receive more complex, aggressive initial treatment; were more likely to have recurrent disease; and were more likely to be followed for a longer time. For example, the average unadjusted cost of care for a patient with ovarian cancer who enrolled in a Phase I or II clinical trial was about double that of a patient with ovarian cancer who did not enroll in a trial ($140,300 vs. $69,100).
However, when the researchers adjusted the data to isolate the effect of trial participation alone, the investigators found that in all but one case, there was no statistically significant differences in the costs of care for patients who were enrolled in trials compared with those who were not.
Study Limited, But Consistent With Others
Martin Brown, Ph.D., of the National Cancer Institute’s Health Services and Economics Branch, noted that the study does have several limitations. First, the study excluded physician fees, looking only at in-patient and out-patient hospital care.
Second, the study used data on charges from hospital billing records. “It is well known that charges can differ markedly from actual payments and underlying resource costs,” said Brown.
Third, costs were adjusted for the type and complexity of the initial therapy. “This may be appropriate for cases where the trial involves therapy following initial treatment failure or for recurrent disease,” said Brown. But it would tend to result in an underestimation of costs associated with those clinical trials that are designed to compare more complex therapies (such as one that uses multiple modalities) with a simpler therapy for initial treatment.
Though the results of this study may not be applicable to all settings, said Brown, the basic conclusions are nonetheless consistent with several others that also looked at this question.
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