Navigating REMS Requirements and Educating Other Stakeholders on Bispecific Therapies

Author(s):

Ryan Haumschild, PharmD, MS, MBA,Issam S. Hamadeh, PharmD, BCPS, BCOP

Key Takeaways

Weekly dosing may provide consistent therapeutic levels, while biweekly dosing reduces hospital visits, affecting patient convenience and healthcare resource allocation.
Formulary decisions should evaluate efficacy, safety profiles, cost-effectiveness, and integration potential into existing treatment regimens.
Patient-specific factors, including comorbidities and previous treatment responses, are crucial in determining the appropriate dosing schedule and formulary inclusion.

Panelists discuss the guidance on managing REMS program compliance for bispecific therapies and strategies for educating non-oncology health care providers about cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) toxicities.

EP: 1.Current Landscape of Bispecific Therapies for RRMM

EP: 2.Operationalizing Bispecific Therapy and the Impact of CAR-T Advancements on Sequencing

EP: 3.Best Practices for Standardizing Step-Up Dosing

EP: 4.Dosing Frequency and Formulary Decisions for Bispecific Antibodies

EP: 5.Resources and Education for Operationalizing Bispecifics

EP: 6.Safety Profiles of Bispecific Antibodies for RRMM

EP: 7.Preventing CRS and ICANS Across Sites of Care

EP: 8.Managing CRS and ICANS: Approaches and Protocols

EP: 9.Infection Prevention and Leveraging EHR for Bispecific Therapy Management

Now Viewing

EP: 10.Navigating REMS Requirements and Educating Other Stakeholders on Bispecific Therapies

EP: 11.Administering Bispecifics in the Community vs Academic Centers

EP: 12.Improving Transitions of Care for Patients Receiving Bispecific Therapies and Final Recommendations

Video content above is prompted by the following

Each of these bispecific therapies has an associated REMS program. What is involved with these programs, and what best practices can you share on successfully meeting REMS requirements?
How can institutions educate health care professionals outside of oncology (eg, primary care, emergency department) about CRS and ICANS in the event patients experiencing these toxicities seek care in those settings?