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.
“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”
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.
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