REMS Management

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The FDA requires manufacturers to implement Risk Evaluation and Mitigation Strategy (REMS) programs for certain high-risk drugs to ensure that products’ benefits outweigh their risks. REMS can vary widely in levels of complexity, ranging from a simple medication guide to much more robust programs that include a communication plan, patient registry, and patient monitoring.

PBMs and specialty pharmacies help drug manufacturers design, implement, and evaluate REMS programs. Without proper management, REMS programs could become overly restrictive and prevent patients from accessing important drug therapies. If REMS requirements are too complicated and cumbersome for patients and their prescribers to follow, it is possible that less effective drugs may be used instead. The ultimate goal of a successful REMS program is to get the right therapy to the right patients at the right time.


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