Experts Moving Toward Consensus on Providing Access to Clinical Trials

FORT LAUDERDALE, Fla--Opinions from a diverse panel of experts, expressed at a special session of the NCCN (National Comprehensive Cancer Network) third annual conference, reflect a nation heading toward convergence on the issue of providing broad access to peer-reviewed clinical trials.

Moderator Clifford Goodman, PhD, of The Lewin Group, a health care policy and management consulting firm, summed up the sense of the panel as basically, "What are we waiting for? I think we have all of the pieces together and the leadership to make this happen."

Robert Young, MD, president, Fox Chase Cancer Center, pointed out that only about half of cancer patients are cured. "Society needs a mechanism by which we can develop new and better forms of therapy, yet only 2% to 3% of cancer patients are entered into trials."

Margaret Tempero, MD, deputy director, University of Nebraska Eppley Cancer Center, said that although NIH grants cover much of the laboratory support required for trials, "some of the routine costs of patient care are not covered by grants or reimbursed by insurers."

Financial costs are not the only barrier to participation in trials. Said Frank Pasqualone, of Bristol-Myers Squibb Oncology: "Physicians often do not have enough time to explain the clinical trial process to patients," and informed consent documents may be inadequate or too complex to allow the patient to make a decision.

The exclusionary language of insurance contracts remains a barrier for many patients, who may not realize trials are not covered until they become ill.

"Plans want to appear to promise everything and may not mention exclusions in their marketing," said Mark Hiepler, a plaintiff’s lawyer who won an $89 million jury verdict for a breast cancer patient whose insurer had denied payment for ABMT. "Investigative is sometimes just another word for too expensive," he said.

Lawrence Rose, Esq, a partner with Hassard Bonnington LLP, San Francisco, cautioned that companies may adopt even more exclusionary language. The "reliable evidence standard," for example, avoids ambiguous language and simply denies coverage for any care provided under a research protocol. "It’s easy for the company to defend, but I would consider it a disaster for society," he said.

Economic or Medical Decisions?

The fact that such decisions are being made for economic rather than medical reasons concerned many panel members. "It should be a doctor-patient decision, not an economically based decision," said Deborah Senn, Washington State Insurance Commissioner. She said that the National Association of Insurance Commissioners has developed model legislation that would require insurers to cover clinical trials "when there is a reasonable expectation that the outcome would be better than with alternative care."

Even this simple definition is open to interpretation. "We called six attorneys and got six different opinions as to what that language meant," she said, adding that the proposal has received "quite a bit of opposition from insurers."

Grace Powers Monaco, JD, director of Medical Care Management Corporation’s Ombudsman Program, which provides legal assistance to cancer patients, encouraged a "systematic, seamless approach to cancer care from initial diagnosis through to the end" that would include clinical trials, a model she believes has been achieved in pediatric care.

Hon. David Durenberger, of Duren-berger/Foote, who served as a US Senator from Minnesota for 16 years, offered a national solution to the problem--a standard minimum benefit package defined by federal law. The package would include a statutory definition of medically necessary and appropriate care, statutory criteria for health plans to follow in making decisions, and an independent science board to issue interim guidelines for expensive new therapies.

Wade Aubrey, MD, of Blue Cross Blue Shield, and Mary Jane England, MD, of the Washington Business Group on Health, representing employer payers, said that payers want strong scientific evidence that new therapies actually affect health outcomes and want to know the incremental cost of clinical trials.

Mary McCabe, RN, of the NCI, said that several smaller NCI trials will yield information this spring about the possible incremental cost of research above that of usual care, and a 1,000-patient study conducted by RAND, Santa Monica, will provide more definitive data.

Dr. Goodman concluded on a note of optimism. "We’re closing in on criteria for payment, and we’re seeing agreement among researchers, payers, and others who control access to care. We’re moving toward a solution."