In the fast-moving field of cancer care, the use of drugs and biologic agents beyond the FDA-approved label accounts for 50% to 75% of the total use of such agents. Since the introduction of interferon in the late 1980s, the provision of coverage for such uses by insurers and managed care companies has been a major and, sometimes, contentious issue. This issue was highlighted again lately by the introduction of innovative, promising biologic agents with high price tags. Additionally, concerns have arisen regarding the adequacy of the 3 compendia recognized by federal and state statutes and federal regulation as mandated references for Medicare and private payors in the setting of coverage policies. One, AMA Drug Evaluations, went out of existence in the early 1990s, and further concerns exist about whether the others (USP-DI, AHFS-DI) can keep pace with innovation to reflect appropriate uses for new agents. Therefore constituencies of the cancer care community have been concerned that appropriate access to effective drugs and biologic therapies might be compromised.
The NCCN Drugs & Biologics Compendium (NCCN Compendium) can fill the breach as an authoritative, evidence-based, and timely source of recommendations for the appropriate use of drugs and biologic agents, including use beyond FDA-approved labeling. On March 30, 2006, a sub-committee of the Medicare Coverage Advisory Committee was convened to study the adequacy of existing compendia as basic mandated references for setting coverage policy. The NCCN testified in strong support of the need to recognize the NCCN Compendium as one of several...
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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.