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National Comprehensive Cancer Network

Educational Events & Programs

NCCN Oncology Policy Summit: Off-Label Drug Use and Compendia

The use of drugs for indications beyond those stipulated in the FDA label has been a physician prerogative that the FDA has approved of for more than 30 years. A high percentage of the use of drugs and biologics in cancer care is off-label. The introduction and utilization of many innovative drugs and biologics in oncology practice, combined with their significant expense, has focused the attention of payors and other involved constituencies on processes and programs that facilitate the appropriate, effective, and efficient use of such agents. Since the late 1980s, drug compendia have been one mechanism to arbitrate such appropriate use in terms of both payors and providers.

On December 17, 2010, NCCN convened the NCCN Oncology Policy Summit: Off-Label Drug Use and Compendia in Washington, DC. The NCCN Oncology Policy Summit examined the use of compendia by public and private payors, looking at issues such as categories of evidence, compendia processes, and availability of data, among others. Further, the Summit explored the existing guidance, and surrounding interpretation, on the legality of dissemination of various clinical and scientific documents that contain off-label uses. The Summit concluded in a roundtable with the Centers for Medicare and Medicaid Services (CMS) recognized compendia where the future of compendia, their use, and their response to current and future events were discussed.


  • Al Benson III, MD,Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • James Cross, MD,Aetna
  • Nancy Davenport-Ennis,National Patient Advocate Foundation
  • Christian Downs, JD, MHA,Association of Community Cancer Centers
  • Scott Gottlieb, MD,American Enterprise Institute for Public Policy
  • Coleen Klasmeier,Sidley Austin
  • Mike Kolodziej, MD,US Oncology
  • Bryan Loy, MD, Humana
  • Bill McGivney, PhD, National Comprehensive Cancer Network
  • Mark Reese,Johnson & Johnson
  • Sam Silver, MD, University of Michigan Comprehensive Cancer Center
  • Mary Lou Smith, JD, MBA,Research Advocacy Network
  • Jill Sutton, Thomson Reuters
  • Kathy Vieson, PharmD, BCOP, Gold Standard / Elsevier
  • Dick Whitten, MD, Noridian Administrative Services