Oncology Risk Evaluation and Mitigation Strategies: Recommendations for Stakeholders

Managing drug safety and developing drug safety systems is an ongoing, critically important challenge for all involved in manufacturing drugs, regulating drug use, prescribing drugs, dispensing drugs, and consuming drugs. Risk Evaluation and Mitigation Strategies (REMS) are the newest tool of the FDA to help manage and ensure safe drug use. The FDA may require manufacturers to develop REMS for both existing drugs and those in development when it determines that special action is needed to ensure that the bene!ts of a drug outweigh its risks. It is recognized that REMS can facilitate the FDA approval of drugs with a high-risk potential that would not otherwise be approved, or allow a drug to stay on the market.

REMS are a particularly important issue for oncology and the NCCN. A disproportionate number of drugs with complex REMS are used in patients with cancer or hematologic disorders. REMS policies and process within oncology may act as a model for other clinical areas. A breadth of experience and access to a wide knowledge base exists within oncology that will ensure appropriate development and consideration of the practical implications of REMS. NCCN is uniquely positioned to assume a leadership role in this process given its status as the arbiter of high-quality cancer care based on its world-leading institutions, clinicians, and pharmacists and its past record of developing the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), widely accepted as the standard for clinical policy in oncology in the United States. Additionally, the NCCN Drugs & Biologics Compendium (NCCN Compendium) is recognized by the Centers for Medicare & Medicaid Services as a mandated reference for oncology coverage policy.

Notwithstanding the potential bene!ts, the successful design, implementation, and analysis of the FDA’s recent requirement for REMS for some highrisk drugs and biologics will present signi!cant challenges for stakeholders, including patients, providers, cancer centers, manufacturers, payors, health information technology vendors, and regulatory agencies. To provide guidance to these stakeholders regarding REMS challenges, NCCN assembled a work group comprised of thought leaders from NCCN Member Institutions and other outside experts. These multidisciplinary thought leaders represented providers (physicians, pharmacists, and nurses), patients, manufacturers, payors, and government/regulatory organizations.

The NCCN REMS Work Group convened on March 13, 2010, during the NCCN 15th Annual Conference: Clinical Practice Guidelines & Quality Cancer Care in Hollywood, Florida. The Work Group identi!ed challenges across the REMS spectrum, including the areas of standardization, development and assessment of REMS programs, Medication Guides, provider knowledge and impact on prescribing, provider burden and compensation, and incorporation of REMS into clinical practice. The Work Group provided recommendations for all of the challenges, some that could be foreseen being implemented in the near future and others that would require collaboration across stakeholder groups and a longer amount of time to implement. Additionally, the Work Group identi!ed metrics that should be collected to assess the impact of REMS on clinical practice, and subsequently developed a survey that was administered through the NCCN Trends Surveys & Data program and through the Oncology Nursing Society (ONS). These recommendations and survey data were presented at the NCCN Oncology Summit: Recommendations for REMS Stakeholders on May 7, 2010, in Washington, DC. . . .

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Scott Gottlieb, M.D., is a resident fellow at AEI.