Experts Brief Capitol Hill on Trial Costs Survey

WASHINGTON—Call it “Fear of Filing.” A survey by the American Society of Clinical Oncology (ASCO) indicates that third-party payers, including Medicare, are more willing to cover patient-care costs in cancer clinical trials than is commonly assumed. Yet often physicians won’t discuss enrollment in such trials with patients out of fear that insurers will deny payment.

“An important point is that even if most claims are eventually paid, the threat of denial does inhibit and does prevent physicians, nurses, and other members of the health care team from enrolling [cancer patients] and, in fact, even talking to individuals about clinical trials,” said ASCO president Joseph S. Bailes, MD. “The problem with the Medicare program is the feeling that these costs will not be reimbursed.”

He discussed the soon-to-be-published survey at a Capitol Hill briefing sponsored by the National Coalition for Cancer Research. The meeting was the second in recent months aimed at countering perceptions in Congress that it would be too costly for Medicare to pay patient-care costs if beneficiaries were enrolled in cancer clinical trials. These concerns are based largely on two points raised by the Congressional Budget Office: That treating patients in clinical trials costs far more than providing standard care, and that patient-care costs are not now covered by third-party payers.

Two identical bills pending in the House and Senate, both titled “The Medicare Cancer Clinical Trials Coverage Act” , would establish a 5-year demonstration project that would cover routine care costs for patients enrolled in cancer clinical trials approved by the National Institutes of Health, National Cancer Institute cooperative groups, FDA, and Departments of Veterans Affairs and Defense.

“Up to 90% of children and teens and 3% of adults between age 20 and 65 with cancer participate in clinical trials,” noted Harmon J. Eyre, MD, American Cancer Society vice president for research and cancer control. “Over age 65, where cancer rates are the highest, only 1.5% of individuals actually go on clinical trials.”

The aging of the US population will dramatically increase the number of Americans who develop the disease, Dr. Eyre said. “Many people have projected that over the next 10 to 20 years, cancer could become the leading cause of death in America, unless we make a major effort to move forward on it, and participation in clinical trials is one area where we need to move,” he said.

ASCO sent questionnaires last year to its roughly 9,000 members working in the United States and received 3,550 responses. The data analysis was completed earlier this year. “It is the most comprehensive look at the clinical trials situation in cancer in the United States,” Dr. Bailes said. “We looked at three areas: oncologists’ experiences and perceptions associated with clinical trial participation; pharmaceutical industry involvement in clinical trials; and non-patient-care costs associated with conducting clinical trials, ie, the research costs.”

The survey clearly demonstrated how important oncologists consider clinical trials. “Oncology is a scientifically driven specialty,” Dr. Bailes said. “Eighty percent of clinical oncologists have participated in clinical trials in the last 3 years.”

ASCO members described several problems they faced in enrolling patients in cancer clinical trials. These include excessive paperwork, inadequate research funding, and strict eligibility requirements for entrance. “The lack of assured third-party payments was clearly a barrier to participation,” Dr. Bailes added.

Nonetheless, oncologists who do enroll patients in clinical trials submit reimbursement claims for routine patient-care costs to Medicare and other insurers in about 95% of their cases, according to the survey—and less than 10% of these claims are denied, except for bone marrow transplants.

Dr. Bailes also cited a General Accounting Office survey of NCI cancer cooperative groups, which found only one instance in a sample of 39 studies in which Medicare had denied reimbursement for patient-care costs. “So the assumption that this is really not being paid for in the Medicare program is not borne out by the data,” Dr. Bailes said. “The conclusion that can be drawn from this is that the cost of coverage for clinical trials patient-care costs is already in the system and would probably have very little overall impact on Medicare,” he added.

Dr. Bailes emphasized the importance of knowing how various cancer drugs affect older patients. “The only way to make certain that these drugs don’t have differential effects is to increase the number of elderly in clinical trials,” he said.

The first of the two NCCR briefings on the Medicare coverage bills, which was held in May, focused on whether the patient-care costs of cancer clinical trials were higher than the costs of providing standard treatment.

It included presentations by researchers from Memorial Sloan-Kettering Cancer Center, the University of Texas M.D. Anderson Cancer Center, and the Barbara Ann Karmanos Cancer Center in Detroit. Studies at these institutions showed that the cost differences were essentially negligible, and, in some instances, clinical trials cost significantly less (see Oncology News International, June 1999, ).

A study presented at the second briefing buttressed this conclusion. Researchers at the Mayo Clinic examined the overall 5-year medical costs in 61 matched pairs of patients treated in NCI-sponsored phase II/III clinical chemotherapy trials. At 6 months, the clinical trial costs were $18,492 vs $17,427 for routine therapy; at 1 year, the difference was $24,660 vs $23,763; and at 5 years, the costs were $43,495 vs $41,375. None of the differences was statistically significant.

$38 a Month

“The difference at 5 years was approximately 5%. This translates to $38 a month,” said Michael J. O’Connell, MD, professor of oncology, Mayo Clinic. “NCI-supported clinical trials added little, if any, to the cost of medical care in this population of cancer patients.”

Some critics oppose Medicare coverage for patient costs in FDA-sanctioned trials funded by for-profit pharmaceutical companies. But Dr. O’Connell argued the importance of paying the costs of older patients in such studies. “Historically, the most promising drugs have emerged from the NCI drug screening program,” he said “Now, the most promising new drugs—angiogenesis inhibitors, vaccines, monoclonal antibodies—are coming from private industry. It is very important for pharmaceutical-supported studies to also be covered.”