ROCHESTER, MINN. -- A Mayo Clinic study has found that the costs for clinical trials, the way cancer patients receive the most promising treatments today and which lead to promising new treatments for the future, are comparable to costs for standard treatment.
"The widely held view by third-party payers is that clinical trials are much more expensive than standard treatment," says Steve Alberts, M.D., Mayo Clinic oncologist and the study's principal investigator. "We now know that costs are not budget breaking. We hope this will encourage reimbursement by third-party payers, which will translate into better access to clinical trials for patients. This access in turn should lead to improved survival and quality of life for patients, and faster advancements in the search for new treatments for all cancers."
The study, to be published in the May 19, 1999, edition of Journal of the National Cancer Institute, finds that the costs of treating patients in clinical trials were modestly higher -- less than 10 percent higher -- than for treating patients who were eligible for the trials but opted for standard treatment. The average total five-year cost in 1995 inflation-adjusted dollars among trial enrollees was $46,424, compared with $44,133 for those who did not enter clinical trials.
Based on the study's findings, the authors recommend payment for patients' treatment in National Cancer Institute (NCI)-approved clinical trials.
The study is the first published of four similar studies. This study was undertaken because payment for care provided as part of clinical research has become more unpredictable due to managed care, and little was known about how entry into cancer clinical trials affects the costs of cancer for cancer patients.
This study is already having an impact on reimbursement as well as legislative policy. Mayo Health Plan, a health maintenance organization affiliated with Mayo Foundation, announced an agreement September 19, 1997, with several national cancer cooperative groups to cover patient care costs of treatment provided as part of NCI-approved trials. This was the first agreement of its kind between the oncology community and private payers and health plans doing business on a region-wide basis. Additionally, based in part on early information from the Mayo Clinic study, UnitedHealthcare, the national health benefits subsidiary of UnitedHealth Group with 7.9 million members, made a similar agreement with the Coalition of National Cancer Cooperative Groups, Inc., that became effective October 30, 1998.
Results of this study also are being considered by a committee at the Institute of Medicine of the National Academy of Sciences that is presently considering potential Health Care Financing Administration (HCFA) policy changes with respect to Medicare coverage of clinical trial costs. As a matter of federal policy, Medicare does not pay for routine patient care delivered in a clinical trial unless that care would be necessary without the trial.
This study was conducted as a matched-case comparison of the incremental medical costs for participation in cancer treatment trials from the date of trial entry until either death or 60 months following entry into the trial. Case subjects were residents of Olmsted County, Minn., who entered Phase II or III cancer treatment trials at Mayo Clinic from 1988 through 1994. Control subjects were patients who did not enter clinical trials, but who were eligible based on their tumor types and other information provided in their medical records. Each case was followed with its corresponding control case for up to five years following the date of clinical trial entry for case subjects or from an equivalent date for control subjects. Hospital, physician and ancillary service costs were estimated from a population-based cost database developed at Mayo Clinic.
The NCI estimates that approximately 8.2 million Americans alive today have a history of cancer, and it expects about 1,221,800 new cancer cases to be diagnosed in 1999. Currently, 2 to 3 percent of all cancer patients, about 20,000 people, enroll in clinical trials each year. The goal of the Association of American Cancer Institutes, which represents Mayo Clinic and 89 other leading cancer centers in the United States, is to increase this number to 10 to 15 percent, or 60,000 patients.
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