By C. Lyn Fitzgerald, Vice President, U.S & Global Development, Edward C. Li, PharmD, BCOP, Manager, Oncology Pharmacy, and Jessica DeMartino, PhD, NCCN Policy Fellow
Risk evaluation and mitigation strategies (REMS) have emerged as a priority topic in cancer care. Since March 2008, when Title IX of the Food and Drug Administration Act of 2007 (FDAAA) went into effect, the U.S. Food and Drug Administration (FDA) 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. The majority of REMS require clinicians to provide patients with an approved medication guide that describes specific risks when particular drugs are prescribed and dispensed. Some REMS oblige providers to comply with precise requirements before a drug can be utilized; these requirements may include the clinician registering in a program, completing education/training, enrolling patients in a registry, and/or completing data collection forms. As the number of approved and requested REMS continues to grow, including class-wide REMS such as for opioids and for erythropoiesis stimulating agents, stakeholders brace for the impact these requirements may have on the delivery of care.
Earlier this year, NCCN convened an NCCN REMS Work Group (Work Group), which includes various thought leaders and stakeholders in the field of oncology. The Work Group was charged with gathering information, addressing how REMS should be applied to cancer care and providing direction for relevant constituents. On Friday, May 7, 2010, the “NCCN Oncology Summit: Recommendations for REMS Stakeholders” (NCCN Oncology Summit) was convened in Washington, DC. Held at the National Press Club, the NCCN Oncology Summit served as a medium for the presentation of the Work Group’s recommendations and 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.
With an aim to assure patient safety while balancing issues concerning barriers to medications and provider workload, members of the NCCN REMS Work Group presented real-world guidance and highlighted the challenges faced when developing and implementing REMS. Key challenges were further illustrated by the data and opinions shared by the respondents of the March 2010 NCCN Trends™ Survey on REMS. The survey questions, developed by the NCCN REMS Work Group, were sent to registrants of NCCN.org, of which 749 responded. The majority of respondents were practicing physicians in an oncology specialty (58 percent). An additional 15 percent were advanced practitioners or nurses in oncology, and 12 percent were pharmacists specializing in oncology.
One of the recommendations discussed during the NCCN Oncology Summit was the need to educate health care providers about REMS. Indeed, according to the March survey, one-third of respondents were unfamiliar with the REMS regulation (30 percent). Thirty-one percent were moderately familiar and only 17 percent responded that they were very familiar with REMS.
The Work Group affirmed that the impact of REMS on provider burden must be assessed and minimized. According to the survey, nearly one-third of respondents spend one to four hours per week on meeting REMS requirements. A subset of respondents (4 percent) spends more than eight hours per week managing REMS requirements.
In addition to the presentations of recommendations, two roundtable sessions, moderated by William T. McGivney, PhD, CEO of NCCN, further advanced the discussion and provided participants with an opportunity to express opinions and ask questions. The roundtable participants were George Dahlman (The Leukemia and Lymphoma Society), Rekha Garg, MD (Amgen), Scott Gottlieb, MD (American Enterprise Institute), James Hoffman, PharmD (St. Jude Children’s Research Hospital), Peyton Howell, MHA (AmerisourceBergen Specialty Group), Mohammad Jahanzeb, MD (University of Tennessee Cancer Institute/Aptium Oncology), Phil Johnson, RPh (H. Lee Moffitt Cancer Center & Research Institute), Shirley Johnson, RN (City of Hope Comprehensive Cancer Center), Emily Mackler, PharmD (University of Michigan Comprehensive Cancer Center), Scott Reid, MD (CVS Caremark), Brenda Sarokhan, MPH (Centocor Ortho Biotech Services), and Sharon Weinstein, MD (Huntsman Cancer Institute at the University of Utah).
NCCN will incorporate discussion points from the NCCN Oncology Summit to refine the recommendation statements developed by the Work Group. A white paper is being developed and will be published in JNCCN and on NCCN.org in 2010. For more information regarding oncology-specific agents requiring a REMS, please visit the NCCN REMS resource tool.