The Issue Is “Off-Evidence,” Not “Off-Label”

Author: William T. McGivney PhD
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On March 30, 2006, a subcommittee of the Medicare Coverage Advisory Committee (MCAC) was convened by the Centers for Medicare and Medicaid Services (CMS) to evaluate the existing drug compendia and to identify the criteria that should guide compendia recommendations about the appropriate use of drugs. The meeting was called to specifically address issues regarding establishing coverage policies by CMS and its intermediaries and carriers for drugs and biologics in cancer care. The focus of these coverage decisions is an issue that has long been referred to as “use beyond FDA-approved labeling” or “off-label” use. Approximately half of the use of drugs and biologic agents in cancer treatment is off-label. This fact should not be surprising in that drugs have historically been approved most often for a single indication and then used for others, not only in cancer care but also in other fields such as psychiatry. Further, in cancer treatment, one is dealing with both life-threatening diseases and fast-paced and abundant research advancement. The U.S. Food and Drug Administration (FDA) has often stated the position that physicians, in the exercise of good clinical judgment, may prescribe drugs for indications other than those explicitly approved by the FDA. Indeed, the issue of “off-label use” attracted substantial attention only in the late 1980s, when insurance companies, as they morphed into managed care companies, began to scrutinize such use more closely. Increased scrutiny was further stimulated in 1987 when interferon was approved for the orphan indication of hairy cell leukemia. That this...

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William T. McGivney, PhD, is the Chief Executive Officer of the National Comprehensive Cancer Network and a recognized expert in coverage policy and drug and device regulatory policy. Before joining the NCCN in 1997, Dr. McGivney directed the Division of Health Care Technology at the American Medical Association and worked for Aetna Health Plans as Vice President for Clinical and Coverage Policy. Awarded the FDA Commissioner's Medal of Appreciation in 1989, Dr. McGivney has served on numerous national boards and committees. He earned his PhD at the University of North Carolina at Chapel Hill and completed a postdoctoral fellowship in the Department of Psychiatry at the Harvard Medical School.

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