NCCN Forum: Who Pays for Clinical Trials?

PHILADELPHIA—A roundtable discussion on who should pay for clinical trials, planned for the third annual conference of the National Comprehensive Cancer Network (NCCN), promises fireworks but also holds out the possibility of consensus building.

“We have tried to put together a panel that includes all the constituencies involved—insurers, payers, a patient advocate, lawyers, a legislator, a state insurance commissioner, oncologists, and the NCI,” said William T. McGivney, PhD, chief executive officer of the NCCN. [See list of participants on page 29.] “They will all be given the opportunity to articulate their concerns and positions,” he added.

In an interview with Oncology News International, Dr. McGivney said that the purpose of the session is “to see how close we all are on the issues and to try to reach a consensus at this meeting that could take the issue forward in terms of public policy or legislative positions. The forum will get all sides in one room and basically air it out.”

He said that when he talks with insurers and researchers in private, he finds that the two are “not all that far off.” He said that in general the big managed care companies are interested in supporting clinical research and getting their members into clinical trials that can answer important research questions.

Dr. McGivney, having been at Aetna for 6 years prior to joining the NCCN, understands the issue from both sides. He said that cancer trials are the focus of this specific issue for managed care companies. “A couple of year ago, the NCI and managed care companies came fairly close to realizing a general agreement about payment for clinical trials of cancer therapies,” he said.

The insurers have stressed the need for greater efficiency in the planning and execution of clinical trials to avoid duplication of effort and ensure that trials will yield meaningful data, “and it is my understanding that the NCI understands that need for greater accountability.”

He noted that managed care plans appear to be more willing to pay for their members to join clinical trials when they are conducted by institutions that have a strong record in terms of research and publications.

Although the roundtable is an opportunity for all sides to discuss general issues, he said that the panel will also address specific case examples, including cases that hinge on the interpretation of contractual language in insurance policies. One of the attorneys on the panel, Mark O. Hiepler, is noted for winning an $89 million judgment against Healthnet in California on behalf of a client with breast cancer who was denied a transplant based on the company’s interpretation of her contract.

For the most part, Dr. McGivney said, the contractual language in most policies—which draw a sharp line between investigational therapies, which are excluded, and established therapies—does not fit the reality of cancer treatment.

In the last few years, he said, “managed care companies have come to realize that binary, yes or no, decision-making does not work completely in certain areas, such as cancer and other life-threatening illness.”

The Gray Area

With many cancers, definitive curative therapies are not available, and the physician may choose to use a “promising” therapy, one that lies in the gray area between investigational and established. If such a therapy has data to support its use and, in the physician’s judgment, is an appropriate intervention, it should not be excluded from reimbursement, Dr. McGivney said.

“This is the type of issue that managed care faces and that the oncology community deals with almost every day in practice,” he said.