Participants in Chemotherapy Trials Incur Minimal Excess Cost

Cancer patients enrolled in chemotherapy clinical trials at the Mayo Clinic in Rochester, Minnesota, incurred a 5-year average cost of $46,424, compared to $44,133 for matched control patients who were not trial participants, suggesting that chemotherapy trials may not involve budget-breaking costs. These findings were reported in the May 19, 1999, issue of the Journal of the National Cancer Institute by Judith Wagner,PhD, of the Congressional Budget Office, Steven Alberts, MD, of the Mayo Clinic, and colleagues.

As a matter of federal policy, Medicare does not pay for routine care delivered in clinical trials unless that care would be necessary without the trial, and payment for care provided in trials has become unpredictable under many private health plans. Therefore, solid information on patient-care costs for trial participants is needed for planning purposes, and the authors believe that this is the first study published on the costs associated with participation in a cancer trial.

The authors accumulated cost data on 61 cancer patients who were enrolled in 36 different phase II or III chemotherapy-based cancer treatment trials at the Mayo Clinic. Control patients were matched as closely as possible to case patients, with the obvious difference that controls were not enrolled in a clinical trial. Cost data were extracted from the Olmstead County, Minnesota, utilization database, a source of provider billing for the county that captures 90% to 95% of physician and hospital services used by county residents.

Cancer Is Generally a High-Cost Disease

Cumulative 5-year medical costs were gathered for all case and control patients, with the exception of the costs of outpatient prescription drugs, durable medical equipment, ambulance and other transportation services, outpatient services provided by allied health professionals, and nursing home care. The cost of the experimental drugs used in the trials, which were provided free of charge, was also excluded.

The average costs for patients enrolled in a clinical trial was higher than costs for the matched control patients. However, in 25 of the 61 pairs analyzed, the control patients had higher total costs than the matched case patients. Some case patients incurred costs that were $200,000 higher than matched control patients, while in other cases the opposite was true.

When the costs were projected over a 5-year period, costs for patients enrolled in clinical trials was approximately $38 more per month than costs for patients not enrolled in trials. The authors conclude that cancer is generally a high-cost disease and that participating in a chemotherapy trial may add relatively little to that cost.

Results Still Preliminary

Editorial writer Martin Brown PhD, of the National Cancer Institute (NCI), says that the usual answer to questions regarding the cost of participation in NCI-sponsored clinical trials has been “We don’t know.” Now, with the results of the new study, it is possible to say “We can, and will, find out.” He notes that the results of the trial should be considered preliminary because of the small sample size and the notoriously high variance of medical cost data.