NCCN Organizing National Summit for Appropriate Use of REMS in Cancer Care

The National Comprehensive Cancer Network (NCCN) announces the NCCN REMS Oncology Summit scheduled for May 2010 to discuss recommendations for the appropriate application of Risk Evaluation and Mitigation Strategies (REMS) in cancer care.

January 12, 2010

FORT WASHINGTON, PA — Risk evaluation and mitigation strategies (REMS), which can be required by the FDA for drugs or biologics with significant toxicity and/or risks, are emerging as a priority topic for a variety of individuals. The goal of REMS to mitigate known or potential drug risks must be balanced with concerns that such programs may be overly complex and burdensome to physicians and other healthcare providers.

To provide direction from key stakeholders in the oncology arena on this important issue, the National Comprehensive Cancer Network (NCCN), an alliance of 21 of the world’s leading cancer centers dedicated to improving the effectiveness and efficiency of care for patients with cancer, is taking a leadership role in the oncology community by planning the NCCN REMS Oncology Summit to discuss issues and recommendations regarding the appropriate application of REMS in oncology.

“Availability of and access to appropriate drugs are essential for patients with cancer. Therefore, the implications of policy decisions and processes regarding REMS must be carefully considered before the implementation of any new REMS policy paradigm,” says William T. McGivney, PhD, CEO of NCCN. “NCCN's reputation in the cancer community properly positions us to take the lead in addressing REMS in such a way as to improve patient outcomes and ensure access to care.”

“Breadth of experience and access to a wide knowledge base are two characteristics that will ensure appropriate development and consideration of REMS within oncology that should be applicable to other clinical areas,” says Philip E. Johnson, MS, RPh, FASHP, Pharmacy Advocacy Director at H. Lee Moffitt Cancer Center Research Institute. “As the arbiter of high-quality cancer care based upon its world-leading institutions, clinicians, and pharmacists and its past record of developing the NCCN Clinical Practice Guidelines in Oncology™, widely accepted as the standard for clinical policy in oncology in the United States - NCCN is uniquely positioned to provide guidance in this process.”

During the REMS Summit, NCCN will present its recommendations regarding the development and implementation of REMS based on the expertise of pharmacists, pharmacy directors, medical oncologists/hematologists, patient advocates, policy makers, and representatives from specialty pharmacy, industry, government, and payors. The NCCN REMS Summit is scheduled for May 2010 in Washington D.C.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network^® (NCCN^®), a not-for-profit alliance of 23 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. For more information, visit NCCN.org.

The NCCN Member Institutions are:

City of Hope Comprehensive Cancer Center
Dana-Farber/Brigham and Women's Cancer Center
Massachusetts General Hospital Cancer Center
Duke Cancer Institute
Fox Chase Cancer Center
Huntsman Cancer Institute at the University of Utah
Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Memorial Sloan-Kettering Cancer Center
Moffitt Cancer Center
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute
Roswell Park Cancer Institute
Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
St. Jude Children's Research Hospital/The University of Tennessee Health Science Center
Stanford Cancer Institute
University of Alabama at Birmingham Comprehensive Cancer Center
UC San Diego Moores Cancer Center
UCSF Helen Diller Family Comprehensive Cancer Center
University of Colorado Cancer Center
University of Michigan Comprehensive Cancer Center
UNMC Eppley Cancer Center at The Nebraska Medical Center
The University of Texas MD Anderson Cancer Center
Vanderbilt-Ingram Cancer Center