Compendia Usage and Off-Label Indications Focus of NCCN Oncology Summit

The National Comprehensive Cancer Network® (NCCN®) announces the latest in its series of Policy Summits, Issues in Off-Label Use and the Applications of Compendia. This NCCN Oncology Policy Summit will explore a broad range of issue areas that impact the availability of and access to drugs and biologics used in the treatment of patients with cancer.

FORT WASHINGTON, Pa.--(BUSINESS WIRE)-- 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.

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.”

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives.

The NCCN Member Institutions are: City of Hope Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Comprehensive Cancer Center, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Memorial Sloan-Kettering Cancer Center, New York, NY; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute, Memphis, TN; Stanford Comprehensive Cancer Center, Stanford, CA; University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE; The University of Texas M D Anderson Cancer Center, Houston, TX; and Vanderbilt-Ingram Cancer Center, Nashville, TN.

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Megan Martin, NCCN
[email protected]

KEYWORDS:   United States  North America  District of Columbia  Pennsylvania

INDUSTRY KEYWORDS:   Health  Biotechnology  Public Policy/Government  Oncology  Pharmaceutical  Public Policy