NCCN Oncology Policy Summit focuses on off-label use of drugs and biologics

The National Comprehensive Cancer Network (NCCN) announced today that key policy organizations and thought leaders will convene to discuss the critically important subject of the use of drugs and biologics for indications that are supported by evidence and compendia, but that are beyond the indications listed in the FDA label. This invitation-only Policy Summit will be held on December 17, 2010 at the National Press Club in Washington DC.

“NCCN believes that many of the issues surrounding the off-label use of drugs and biologics need to be addressed in a public forum with all involved constituencies present and participating. This will be achieved by the NCCN Oncology Policy Summit.”

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 will 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.

The NCCN Oncology Policy Summit will examine 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 will explore the existing guidance, and surrounding interpretation, on the legality of dissemination of various clinical and scientific documents that contain off-label uses. Finally, in a roundtable with the four Compendia, the Summit will discuss the future of compendia, their use, and their response to current and future events such as the advent of molecular markers, calls for greater public transparency, availability of compendia information, use and categorization of existing evidence, and use of comparative effectiveness.

"The availability of a broad therapeutic arsenal of innovative drugs and biologics is essential for the treatment of the vast array of diseases that we call cancers. It also is critical that these agents be used appropriately and efficiently," said William T. McGivney, PhD, CEO of NCCN. "NCCN believes that many of the issues surrounding the off-label use of drugs and biologics need to be addressed in a public forum with all involved constituencies present and participating. This will be achieved by the NCCN Oncology Policy Summit."