Table A4.

Decision Tool for an Alternative REMS Approach for Hematology/Oncology Products

The workshop organizers presented a suggested approach that involves a decision tool to guide decision making about REMS development and implementation for hematology/oncology products. The tool would place each drug into one of three possible levels:

Level 1 would apply to drugs with toxicities similar to those already well managed in clinical practice; this would include the majority of oncology drugs. Level 1 drugs would not need an REMS. The FDA and the drug manufacturer would provide standard information, but no changes to standard practice would be required.

Level 2 would apply to drugs that carry risks different from common toxicities. These toxicities, however, are manageable given appropriate evidence-based information because of safety measures already common to clinical practice. An REMS program for a level 2 drug would involve a core set of safety information developed by the FDA and the drug manufacturer. The oncology community could then assist in further developing and disseminating important information through various education and communication vehicles. If applicable, laboratory testing or other safe-use procedures could be incorporated into an EHR.

Level 3 would apply to drugs that would not be approved in the absence of risk mitigation strategies. Level 3 drugs carry serious, unique risks that should be highlighted for providers and patients and cannot easily be managed by existing practice measures. This could also apply to drugs that carry a specific risk not familiar to a given provider population. REMS programs to manage these drugs should integrate drug safety information in real time in a way that assists patient and provider decision making. Examples could include evidence-based guidelines created by professional organizations, decision aids embedded in EHRs, and quality measures to assess comprehension and implementation into practice.

Abbreviations: EHR, electronic health record; FDA, US Food and Drug Administration: REMS, Risk Evaluation and Mitigation Strategies.