Routine Medical Care Costs for Cancer Patients Only Slightly Higher for Those in Federal Clinical Trials

A study issued today by RAND and the National Cancer Institute found that medical care for the average patient who enrolls in a federally funded cancer clinical trial costs an average of $892 more each year than if that patient had not enrolled in a trial.

Over two and a half years ending in 1999, patients who were good candidates for clinical trials accumulated about $33,000 in medical costs. Adding about $900 annually for routine care for those in clinical trials would not have a major financial impact on health insurance companies, the study found.

Less than 3 percent of all cancer patients, or about 19,000 people, enrolled in federally funded cancer clinical trials in 1999.

“The question we answered is how much extra money would an insurance company expect to pay if it allowed its cancer patients to enroll in any federally sponsored cancer clinical trial,” said Dana Goldman, the study's lead author and director of health economics at RAND. “The answer is, not a lot. Our study shows that lack of insurance coverage should not be an obstacle that prevents cancer patients from enrolling in studies of promising new treatments.”

The finding should put to rest any remaining resistance by the insurance industry to covering the medical care costs for patients in these trials, including doctor visits, hospital services, laboratory tests, and other diagnostic services. The results from clinical trials determine whether new treatments are effective and whether they should be approved for widespread use.

Appearing in the June 11 edition of the Journal of the American Medical Association, the study is the largest examination ever conducted of the cost of treating cancer patients enrolled in government-sponsored studies of new cancer treatments. The project was conducted by researchers from RAND Health and RAND's Science and Technology Policy Institute.

The cost of conducting cancer clinical trials is supported by a combination of research sponsors, medical institutions and insurance providers. However, some insurance companies have been reluctant to pay for the routine medical care of patients enrolled in clinical trials because they fear costs may be substantially higher.

Advocates for cancer patients have worried that the insurance coverage issue might keep some people from enrolling in clinical trials and drive up the cost of trials. There was concern that sponsors would need to pay too much for patients' routine care in addition to the experimental therapies, data collection, and other costs associated with conducting a study.

“The uncertainty about insurance payments has an effect on doctor participation in clinical trials, patient participation and maybe even on how the clinical trials are designed,” Goldman said. “Our study shows that open reimbursement for clinical trials is not an expensive proposition. But it could have a long-term benefit for how we treat cancer.”

Studies at single institutions had suggested that there was not a large difference in costs between patients in clinical trials and patients receiving standard care. To determine whether this experience was universal, researchers from RAND and the National Cancer Institute examined the costs of about 1,600 adult cancer patients treated at 38 centers across the country during 1999.

Study sites included both academic settings and community based treatment sites. Participants included patients in clinical trials and patients undergoing standard cancer therapy.

Overall, patients in clinical trials had routine medical costs that were 6.5 percent higher than their non-study peers. Costs were highest for patients enrolled in early phase studies of experimental treatments, when patients are followed most closely for side effects and other problems. The higher costs amounted to about $16 million annually.

Researchers found the higher costs were caused by more physician visits, more expensive tests such as magnetic resonance imaging and more pathologic studies. Much of the increase in services was among patients who were terminally ill, suggesting that patients enrolled in clinical trials receive more aggressive care as they become sicker, Goldman said.

This study reinforces the decisions made by insurance programs in recent years to pay for the routine medical care provided in clinical trials. The American Association of Health Plans, which represents managed care insurance companies, recommended in 1999 that its members pay for the costs. Medicare, the government insurance program for the elderly and the disabled, agreed to cover the services in 2000.

RAND examined only government-sponsored clinical trials. Researchers say the results may not apply to cancer studies sponsored by drug companies and other industry groups because those efforts may involve different types of cancer and different treatments.

Support for the study was provided by the National Cancer Institute. Additional funding came from the National Institutes of Health and from the National Science Foundation.

Other authors of the report are Sandra H. Berry, Michael L. Schoenbaum and Matthias Schonlau, all of RAND; Mary S. McCabe, Arnold L. Potosky and Richard Kaplan, all of the National Cancer Institute; Meredith L. Kilgore of the University of Alabama at Birmingham; Jane C. Weeks of the Dana-Farber Cancer Institute; and Jose J. Escarce of RAND and the David Geffen School of Medicine at UCLA.

About RAND Health
RAND Health is the nation's largest independent health policy research organization, with a broad research portfolio that focuses on medical quality, health care costs and delivery of health care, among other topics.

About the Science and Technology Policy Institute
RAND's Science and Technology Policy Institute is a federally funded research and development center sponsored by the National Science Foundation. The institute conducts objective, independent research and analysis on public policy issues involving science and technology.