A group of health insurers and employers have told an Institute of Medicine panel that there needs to be some means to regularly evaluate whether new drugs, devices, or procedures work and whether they are worth the cost. Without such evaluation, insurers cannot decide whether to underwrite new developments as they emerge from clinical research, and employers cannot know whether the insurance coverage that they provide to their employees is benefiting them.
"We are spending billions of dollars and a lot of patient and caregiver time in the development of new and promising technologies, but we have no matching investment in the evaluation of these new innovations," said Sean Tunis, M.D., director of coverage analysis at the Centers for Medicare and Medicaid Services at a workshop held by the Institute of Medicines Clinical Research Roundtable in December. He and other speakers made it clear that they expect clinical researchers to provide this evaluation.
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"They are poorly served by the output of the clinical research enterprise [which] is unaccountably silent on this point," he said. "And the problem is growing more acute with the pace of medical innovation."
"We need to know what works and what doesnt," said George Isham, M.D., medical director of HealthPartners, Minneapolis, Minn., a group of nonprofit health care organizations with about 600,000 members, addressing the panel. Isham was particularly concerned about discovering what is not effective. "We get a lot of information about new things, but not much about the existing ones," he said.
The United States spends around $1.3 trillion annually on health care, and the figure is increasing. "Payers expect that their dollars [will] be spent wisely," said another speaker, Eric Book, M.D., of Wellmark Blue Cross Blue Shield, a group that insures about one-half the population of Iowa and one-third of the population in South Dakota. Book pointed to the recent experience with autologous bone marrow transplantation for advanced breast cancer, a widely touted procedure for which many patients demanded coverage by their insurers but that was subsequently shown to be ineffective. (See News, June 16, 1999, p. 992.)
"What we dont want is to be pushed into coverage, either by public opinion or by the courts, for a treatment that has not been proven or demonstrated to be cost-effective," Book said. "What we do want from the clinical research enterprise is evidence that there is disciplined and robust management. We need assurance and understanding that the research focus is appropriately prioritized and managed for cost-effective outcomes."
But by expecting traditional clinical research to provide this information, the insurers may be barking up the wrong tree. Conventional clinical research can, and usually does, establish efficacy in well-designed controlled studies. The problem arises when it comes to delivering these results to patients. The evidence shows that "there are barriers to practicing and delivering efficacious medicine to patients outside of the research environment," said Dennis Scanlon, Ph.D., of Pennsylvania State University, University Park.
Another panel member, Myron Genel, M.D., Yale University School of Medicine, New Haven, Conn., said that well-conducted studies, modeled on industrial research, into how the results of clinical research are translated into clinical practice are needed to get around these barriers.
"We need to decide what studies we are going to devote our resources to," said Reed Tuckson, M.D., vice president of consumer health at UnitedHealth Group, an organization that offers a variety of nationwide health care plans and services. "What is the threshold to determine whether the improvement is worth the effort? What is the process by which we make these choices and those decisions? We do not have a vehicle that allows that analysis. We really need to know how the new intervention compares with other drugs and devices that are already available."
Given the incentive, it may seem a simple matter to find out what works and what does not. But efforts to do so have a checkered history in American medicine. The National Center for Health Care Technology, created in the 1970s specifically to evaluate medical and surgical procedures, was opposed by organizations such as the American Medical Association, and it eventually disappeared. The Agency for Health Care Policy and Research was criticized for some of its clinical practice guidelines and "almost went out of business," as Francis Chesley M.D., director of the agencys Office of Research, Review, Education, and Policy, reminded the panel.
In its reincarnation as the Agency for Healthcare Research and Quality, the agency no longer issues such guidelines directly. Rather, it works in partnership with groups such as the American Medical Association and the American Association of Health Plans. "We try to work together to bring those evidence-based guidelines to practitioners," Chesley said. "Only in that way have we been able to accomplish something real, at least in terms of bringing evidence-based information to the practitioner."
The roundtable panelists suggested that this system needs improvement. "The advancement of health in the nation depends on all the pieces working together in a much better way than they do right now," said Enriqueta Bond, Ph.D., president of the Burroughs-Wellcome Fund, Research Triangle Park, N.C., and co-chair of the workshop.
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The Clinical Research Roundtable was established by the Institute of Medicine to provide a forum for discussing issues facing clinical research. It has 29 members drawn from academic health centers, federal agencies that sponsor and regulate clinical research, private sector sponsors of clinical research, foundations, health plan insurers, purchasers of health care, and patient representatives. The group meets quarterly. Its deliberations are available on its Web site: http://www.iom.edu/crr.
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