Patient Care Costs of Clinical Trials May Be Less Than Standard Care

WASHINGTON—Accumulating evidence shows that the additional cost of treating cancer patients in clinical trials vs that of providing standard care is essentially negligible, and, in some instances, treatment on protocol is significantly less expensive, experts said at a congressional briefing sponsored by the National Coalition for Cancer Research.

The briefing was specifically aimed at supporting proposals pending in the House and Senate that would create a clinical trials demonstration project to determine the true costs of cancer clinical trials to the Medicare system. During this project, Medicare would be required to pay the costs of routine patient care for its beneficiaries participating in clinical trials, which it does not do now.

“There has been some feeling, particularly here on Capitol Hill, that saying Medicare would support patients entered in clinical trials would somehow increase the cost. We believe that, in fact, it would decrease the cost,” said Jerome W. Yates, MD, MPH, senior vice president for clinical affairs at Roswell Park Cancer Institute, who moderated the session. “One of the reasons we’re concerned about this is because the insurance carriers tend to follow the lead of Medicare.”

The Congressional Budget Office and the Health Care Financing Administration (HCFA) estimate that paying patient care costs for Medicare beneficiaries enrolled in clinical trials would increase the patients’ treatment costs by 10% to 20%, said George J. Bosl, MD, of Memorial Sloan-Kettering Cancer Center. “That notion is based upon data that I can’t find,” he added. “Until recently, I would say there were very little data that would say anything.”

Memorial Sloan-Kettering Study

Dr. Bosl described a soon-to-be-published cost-comparison study involving 152 matched cancer patients who were treated at Memorial Sloan-Kettering. Half the patients were enrolled in clinical trials; the other half received standard care. A cost analysis showed the average cost of treating the research patients was 20% less: $29,741 per patient for the clinical trials groups vs $37,201 for standard care.

“Hospital costs were 23% less for study participants than for the standard-care patients; professional services, 9% less; inpatient costs, 27% less; and outpatient costs, 18% less,” Dr. Bosl said. Radiation therapy costs were 25% lower for the clinical trials patients as were drugs and supplies; operating room costs were 8% less; and the research patients spent 24% fewer days hospitalized (Table 1).

“From the perspective of those of us who have had a chance to look at our institutional data and are awaiting other data to come out, clinical trials cost the same or less,” Dr. Bosl said. “There is no real reason to expect them to cost more, either in the Medicare population or in the population at large.”

M.D. Anderson Cost Model

Evidence from studies of ovarian, prostate, and lung cancer patients at the University of Texas M.D. Anderson Cancer Center support Dr. Bosl’s statement, said Melinda M. Branch, MPA, the center’s manager for research administration. M.D. Anderson has been developing a cost model for the past 4 years in an effort to estimate costs. This model has been validated by reviewing actual patient care charges for more than 3,000 patients enrolled on standard care pathways or clinical trials at the Center.

Among the ovarian cancer patients, the average cost for treating patients enrolled on the clinical trial was $13,802, 35% less than the $21,130 per patient cost for women enrolled on the standard care pathway. For lung cancer patients on the clinical trial, it cost an average of $15,650 per patient, 36% less than the $24,536 average cost of the standard care pathway treatment. Among prostate cancer patients, the average cost for the clinical trial was $16,775, only 2% higher than the average cost of $16,478 for the standard care pathway (Table 2).

“Clinical trials are not more costly than standard care,” Ms. Branch said. “Often they are less costly because you avoid having unnecessary treatments and tests, and the clinical drugs are provided by the sponsors. Clinical trials are ethical and economic medical values.”

William P. Peters, MD, PhD, director of the Barbara Ann Karmanos Cancer Institute, Detroit, described findings from studies of breast and lung cancer patients there. Among the lung cancer group, the average cost over 6 months for patients on protocol was 93% of the cost of those receiving the standard treatment. Among breast cancer patients, the average cost for study participants was 104% that of the standard care group.

“Right now, the Congress is funding the NIH and the NCI substantially,” Dr. Peters said. “You can cure all the animals you want, but until you translate that into the patient and actually prove the value for the patient, you are wasting your money. The clinical research portion is critical to the final outcome.”

University of Minnesota Results

Dr. Yates also described findings from a study at the University of Minnesota, led by S.R. Alberts, MD. This case-control comparison matched 61 patients in clinical trials against those receiving customary treatment. The mean costs over the first 6 months were $18,492 for the research patients and $17,427 for those receiving customary care (P = .84). Although the total dollar average was higher in clinical trials, “statistically there was no difference,” Dr. Yates said.

Two speakers suggested that Medicare was discriminating against its own beneficiaries by refusing to pay their patient care costs so they can take part in clinical trials. “Failure to allow a patient to participate in a clinical research study relegates them to ineffective and outdated care,” Dr. Peters said. “It is discriminatory, for example, to elderly patients who are not being allowed to participate in clinical research studies.”

Dr. Yates added: “The leadership of the US in medicine has largely been built on the shoulders of clinical trials. If we are going to have guidelines to manage patients in the community, we need to develop the evidence for this. And the evidence comes from clinical trials.”