NEWS

More States Mandate Coverage of Clinical Trial Costs, But Does It Make a Difference?

Gail McBride

In the last few years, a number of states have enacted legislation aimed at increasing the accrual of patients into cancer clinical trials. Beginning in 2000, 13 states enacted laws mandating that managed care and individual and group insurers cover most routine medical care associated with participation in cancer clinical trials. That is in addition to the six states that already had such laws on the books; Rhode Island was the first in 1994 (see Stat Bite, p. 1269).

Instead of a law, New Jersey in late 1999 achieved a consensus agreement whereby all insurance companies operating in the state agreed to basic tenets regarding reimbursement for patient participation in government-funded phase I, II, and III cancer clinical trials. Michigan also has a cooperative agreement among insurers to cover cancer clinical trials.

Despite these efforts, very little information is available on whether such mandates have made a difference in clinical trials accrual. There is no central repository for data on numbers of people participating in clinical trials in each state each year, no mandates for data submission, and no way to track just how many people overall actually participate in cancer clinical trials.

Even the American Cancer Society (ACS), whose staff and volunteers have been active in getting these laws passed in various states, does not collect information on the laws’ effects, explained Rachel Tyree, manager of communications and media advocacy of the ACS’s national government relations department. She added that many people simply estimate total national trial enrollment by doubling the cooperative group numbers. As for ascertaining any changes in accrual rates in states with such laws on the books and then comparing them with those of states without such laws, demographic and geographic variables among states would make this unreliable, according to epidemiologists at the ACS.

In addition, accrual to clinical trials varies from year to year, often depending on the availability of certain large adjuvant phase III trials involving, for example, treatment of breast or colon cancer, said Jean Roark, an administrator with Cancer and Leukemia Group B.

Also affecting accrual—although primarily in states without state insurance mandates—is the fact that some oncologists may enroll certain patients in clinical trials but simply not tell the patients’ insurance companies, hoping to avoid reimbursement problems for patients.

Nevertheless, there is some information on the effects of these mandates on the smallest state—Rhode Island—and the largest state—California. And New Jersey has its own story.

Rhode Island

The Rhode Island Cancer Council, chaired by Paul Calabresi, M.D., professor of medicine and medical science at Brown Medical School, studied accrual rates before and after passage of the state’s 1994 law. Results were surprising. "We are very disappointed to tell you," said Calabresi, "that it has made no difference."

Overall participation of cancer patients in clinical trials in the state remains at 5% to 6%, although it is higher at Brown University Hospital (10% to 15%). Even so, about one-third of the state’s hospitals are affiliated with Brown, and most oncologists have some kind of appointment at the school.

So why is the accrual rate so low? Recently, the Rhode Island Cancer Council sent a survey to some 80 oncologists; about 40 replied. "The major message we got was lack of time by the doctor to explain the protocol, explain informed consent, and obtain informed consent," said Calabresi. "The major recommendation: greater participation by nurse monitors or research nurses to explain these things and enroll patients in trials."

Another possible reason that Rhode Island’s accrual rate has not increased is that the state is already well reimbursed. "We have a lot of older patients on Medicare who are now reimbursed, and total insurance coverage is about 93% in the state," Calabresi explained. "So insurance payments probably do not make that big of a difference."

California

In a 2001 article in the Journal of Clinical Oncology, Primo N. Lara Jr., M.D., associate professor of hematology and oncology, and colleagues at the University of California Davis Cancer Center reported results of a prospective study at the institution to identify potential barriers to clinical trial enrollment during periods in 1997, 1998, and 2000. In an initial group of 276 patients, the accrual rate to clinical trials was 14%. Among the 76 trial-eligible patients, 37 (49%) declined to participate, with 8% of those patients citing denial of insurance coverage as the reason. This was particularly true of patients with private insurance as opposed to government-funded insurance.

In 2002, California’s law mandating that private and government insurers cover routine costs associated with cancer clinical trials went into effect, so the UC Davis Cancer Center group repeated the earlier study. This time, only 16 (31%) of 51 trial-eligible patients declined to participate but in no instance was this the result of insurance limitations. Lara believes that these results, while only pertaining to UC Davis, can be extrapolated to the entire state.

"This suggests that, while the overall rate of accrual is only slightly increased after passage of SB 37 [California’s law], patients may be more willing to enroll and a significant barrier to participation can be hurdled," Lara said. "Efforts to increase participation must include enhancing physician and patient awareness of [the law]."

Recently, a consortium formed by NCI and five pharmaceutical companies awarded the UC Davis Cancer Center a $1 million grant for programs to overcome barriers to early phase clinical trials. Five other cancer centers also received grants. Lara and colleagues plan to use some of this new grant money to stage a "multi-media blitz" to inform cancer patients and their caregivers that clinical trials are available in California and that routine medical costs will be reimbursed. They also plan to enhance access to investigational drugs in phase I trials by redesigning the trials (for example, by use of intrapatient dose escalation and relaxation of eligibility criteria), and to investigate and remedy communication breakdown between patients and physicians, patients and caregivers, and patients and the research team.

In New Jersey, one state where insurance companies have voluntarily agreed to reimburse for routine costs of clinical trial participation, there have been some changes. In late 1999, when the agreement went into effect, about 620 patients were enrolled in clinical trials at the Cancer Institute of New Jersey. In 2002, the number was 1,079, according to Mary Todd, M.D., deputy director of the institute. Whether an increase in accrual has occurred throughout the state is unknown, she added.

"Of course, the center was growing at the same time," said Todd, "but certainly our faculty are finding that they’re spending a lot less time negotiating with the managed care companies. It’s also my impression that in some states where laws mandating coverage were passed, there’s still some antagonism between researchers and the managed care companies, whereas in New Jersey, these companies increasingly are big advocates of clinical trials."

A few other states have contacted Todd, who was very involved in the consensus agreement, about trying to do the same thing. "It’s hard initially to get insurers to the table," she said. "I think we were able to do it with the implied threat of a law. Once they got to the table and understood the issues surrounding cancer—it took about a year—things became easier. We all had a lot to learn."

The Coalition of National Cancer Cooperative Groups has also seen an increase in clinical trial accrual. In 1997, when the coalition was established, the accrual total was 19,000. In 2001, the figure was almost 27,000.

Robert L. Comis, M.D., president and chairman of the coalition, attributed this increase to the group’s efforts to increase awareness by working with national organizations, industry, the media, patient advocate groups and, in the last year, with states to help them develop a "platform for clinical trials."



             
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