Risk Evaluation and Mitigation Strategies [REMS] Program Considerations For Bispecific Therapy

EP: 1.Conditions for Administering Bispecific Therapy

EP: 2.Navigating Barriers Which Inhibit Optimal Use of Bispecifics

EP: 3.Key Decision Makers and Contributors Involved In Bispecific Administration

EP: 4.Pain Points In Bispecific Operationalization

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EP: 5.Risk Evaluation and Mitigation Strategies [REMS] Program Considerations For Bispecific Therapy

EP: 6.Optimizing Bispecific Use Through EMR Utilization

EP: 7.Best Practices For Uptake and Use of Bispecific Therapy

EP: 8.Achieving Seamless Care Transitions With Patients Receiving Bispecific Therapy

EP: 9.Intro to Bispecific Therapy: Implementation Essentials for Novice Institutions

EP: 10.Key Elements In Monitoring for Potential Adverse Events with Bispecific Antibodies

EP: 11.Protocol For Urgent and Around-the-Clock Bispecific Care

EP: 12.Obstacles to Optimal Transitions of Care Between Academic and Community Settings When Utilizing Bispecific Antibodies

EP: 13.Managed Care Considerations Within Bispecific Landscape

EP: 14.Payor-Provider Collaboration Driving Optimal Bispecific Therapy Strategies

EP: 15.Medication Assistance Programs Mitigating Financial Burden For Patients Receiving Bispecific Therapy

EP: 16.Bispecific Therapies: Current and Future Considerations

The following is a video synopsis/summary of a Peer Exchange involving Ryan Haumschild, PharmD, MS, MBA, CPEL; Kirollos Hanna, PharmD, BCPS, BCOP, FACCC; Sarah Rockwell, PharmD, BCOP; Melody Chang, RPh, MBA, BCOP; and Ryan Cain, PA-C.

In this discussion, the focus is on the Risk Evaluation and Mitigation Strategy (REMS) program, particularly in the context of bispecific antibodies used in cancer treatment. Dr. Rockwell shares the experience of Florida Cancer Specialists with the REMS program, specifically with teclistamab and talquetamab, which recently received FDA approval. The transition within the REMS program is described as operationally smooth, with designated clinical nurse managers and operational champions overseeing the process across multiple clinics. The emphasis is on ensuring providers are certified through the REMS program, involving documentation at each injection to confirm providers' up-to-date certification.

The discussion delves into the complexities of the REMS program, including step-up dosing requirements and associated hospitalization protocols. Dr. Rockwell highlights the importance of administering a wallet card to patients, providing documentation in case of adverse effects when seeking emergency care. Despite initial concerns about the paperwork and documentation associated with the REMS program, the overall experience is described as very smooth.

The conversation shifts to the challenges and considerations related to cytokine release syndrome (CRS), a common side effect of bispecific antibodies. Different approaches to therapy, including inpatient and outpatient settings, risk stratification, and financial considerations, are explored. Dr. Hanna emphasizes the need for infrastructure to monitor patients during the ramp-up phase and discusses the lack of a well-defined approach for inpatient versus outpatient care.

The discussion concludes with considerations for community practices collaborating with hospitals, addressing the financial aspects, and ensuring a seamless transition of care for patients completing therapy. Key points include the importance of relationships between hematologists at different institutions, EMR integration, and having clear protocols for managing adverse events like CRS in the community setting. Overall, the speakers stress the significance of a structured approach to ensure effective and safe cancer therapy administration.

Video synopsis is AI-generated and reviewed by AJMC editorial staff.