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NCCN Draft REMS White Paper Now Available for Comment on NCCN.org

By Ed Li, PharmD, BCOP, Drugs and Biologics Editor, and Kate Barker, Communications Coordinator

The ramifications of Risk Evaluation and Mitigation Strategies (REMS) are raising concern among clinicians and stakeholders in the cancer care delivery system. NCCN has drafted a REMS White Paper, “NCCN Oncology Risk Evaluation and Mitigation Strategies Work Group Recommendations for Stakeholders,” which describes the implications of the applications of REMS in oncology and outlines recommendations for stakeholders. The draft of the NCCN REMS White Paper has been posted on NCCN.org and is available for a four-week comment period.

In response to the impending repercussions of REMS in oncology, NCCN took a leadership role and earlier this year convened an NCCN REMS Work Group (Work Group). The Work Group, which includes various thought leaders and stakeholders in the field of oncology, were charged with gathering information, addressing how REMS should be applied to cancer care and providing direction for relevant constituents. On May 7, 2010, the NCCN Oncology Summit: Recommendations for REMS Stakeholders (NCCN Oncology Summit) was convened in Washington, DC.  The NCCN Oncology Summit served as a medium for the presentation of the Work Group’s recommendations and as a forum for further discussion of issues surrounding the development and implementation of REMS in oncology.  In addition to leading oncologists, a broad array of organizations participated in the NCCN Oncology Summit and the dialogue; the American Cancer Society Cancer Action Network, Friends of Cancer Research, The Leukemia and Lymphoma Society, the U.S. Food and Drug Administration, the American Medical Association, CVS Caremark, and Aetna are among the many organizations that were represented.  The recommendations derived from the collaborative effort of the Work Group and from relevant discussion at the NCCN Oncology Summit are incorporated into the 44-page REMS White Paper.

Since 2008, the U.S. Food and Drug Administration has had the authority to require a REMS for both existing drugs and drugs in development; the agency determines if special action is needed to ensure that the benefits of a drug outweigh its risks and a REMS requirement is thus applied. Recent changes resulting from REMS regulations have left clinicians and stakeholders in oncology concerned about burdensome workloads and the possibility of disparities in standard of care.

At the conclusion of the comment period for the NCCN REMS White Paper, NCCN will revise the draft, and the final version will be published in JNCCN — Journal of the National Comprehensive Cancer Network in the Fall of 2010.  This special issue of JNCCN will feature an update on the status of managed care in oncology, a report on the challenges clinicians face in managing cancer-associated anemia, and other relevant articles.  To ensure receipt of this special edition of JNCCN, contact us.  For more information regarding oncology-specific agents that require a REMS, please visit the NCCN REMS Resource Tool.

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