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Even With Coverage, Patients Avoid Clinical Trials

Even With Coverage, Patients Avoid Clinical Trials

MINNEAPOLIS—Of the many possible reasons why cancer patients choose not to enter clinical trials, worries about whether the cost will be reimbursed by their health plan may actually rank low on the list, or so the experience of Minneapolis-based UnitedHealth Group suggests.

In December of last year, the company signed an agreement with the Coalition for National Cooperative Cancer Groups (CNCCG) to waive the normal exclusion in its health plans for experimental or investigational treatment for patients who enrolled in trials sponsored by any of the cooperative groups in the CNCCG, including prevention studies.

The health plans include an open-access model (UnitedHealthcare), which reimburses most of its physicians on a fee-schedule basis and has no “gatekeepers” or requirements for referrals, and Uniprise, which serves large, self-funded customers such as GE and Coca-Cola. There are approximately 300,000 physicians in the company’s network.

The CNCCG includes six of the cooperative oncology groups sponsored by the National Cancer Institute. It has approximately 300 to 400 clinical trials ongoing at any given time.

“One restriction was that the studies had to be multicenter trials. This was because we wanted to support the most important trials, and we felt that multicenter trials had a priority over single-institution trials,” Lee N. Newcomer, MD, senior vice president for health policy and strategy, said in an interview.

Announcements of the agreement, which took effect in January 1999, were sent to all health plan members (some 7 million eligible enrollees), and participating physicians, and the agreement received attention from both the general and oncology media.

Yet after nearly a year in place, the plan has had almost no takers. “There have been fewer than 10 inquiries, and only two patients were actually eligible for treatment and have enrolled in a trial,” Dr. Newcomer said. “It was surprising to all of us that even with coverage, people are not enrolling in trials.”

The agreement includes a provision requiring that out-of-network institutions accept the company’s regular payment rate for a particular patient’s plan, “so we wouldn’t have to get a new contract every time a patient had to go to a center that wasn’t within our networks,” Dr. Newcomer said.

The quid pro quo is that the company “agreed not to quibble over what was necessary for the trial—any care that a patient needed we would reimburse.”

UnitedHealthcare set up a pilot study to track and analyze the costs incurred by patients enrolled in trials, and the agreement with the CNCCG allowed for the program to be suspended if expenses “were rampantly out of control,” Dr. Newcomer said. “We would then use those cost analyses to figure out our next approach.” However, with almost no members taking advantage of the plan, cost has not, to date, been a consideration in whether or not to continue the program.

Dr. Newcomer noted that prior to the agreement with the CNCCG, United-Healthcare had offered to pay the costs of breast cancer patients enrolled in national clinical trials of high-dose chemotherapy supported by bone marrow or stem cell transplant, with similar lack of consumer interest.

Dr. Newcomer offered several possible explanations for the low use of the new program. “Patients are often scared of trials. They may find informed consents difficult to read. They may have to travel to receive treatment and don’t want to be away from home.” He noted that travel costs are not reimbursed.

He acknowledged that it is often difficult for medical directors, case managers, and patients to know which trials are available. “We have a website to help patients and their doctors identify trials for which they may be eligible,” he said. And the company is also working with cancer patient advocacy groups to educate patients about the value of clinical trials.

“I believe that clinical trials offer better care, but we must find a way to encourage patients to enter those trials. It’s not the money that is the barrier,” Dr. Newcomer concluded.

 
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