All healthcare providers (HCPs) involved in prescribing multiple myeloma bispecifics should be certified in the REMS requirements. To become certified, providers must successfully complete the Knowledge Assessment, submit the Prescriber Enrollment Form, and, before treatment initiation (first dose), counsel patients or their caregivers using the Patient Wallet Card. Complete and provide patients or their caregivers with the Patient Wallet Card. Additional REMS certification details are available in our J&J Resource Library.

J&J REMS Certification Details

It’s important to provide initial and follow-up training and education to the care team to ensure your staff is prepared and confident.

Topics for education may include:

• Bispecific therapy for multiple myeloma, such as efficacy and safety, dosing considerations, infection prophylaxis, pretreatment for ARs, and clinical pearls
• Standard operating procedures (SOPs) and treatment protocols, such as AR management and transition of care/care
  coordination transition of care/care coordination

Whether your patient is receiving care at a single site or across multiple locations, for successful outcomes it is crucial to assess your organization’s current infrastructure and ability to support patients through both initiation (step-up) and treatment dosing. Depending on your facility setup, patients may either stay at one site for their entire treatment or transfer to a different location.

Consider the following when coordinating care during transitions between care settings:

• Site of care preparation, including REMS certifications and AR management preparedness
• Site of care roles and responsibilities, such as conducting benefits investigation/prior authorization (BI/PA), treatment plan development and review, patient scheduling, follow-up care/re-hospitalization, and patient and care partner support. A Memorandum of Understanding (MOU) may be helpful in establishing roles and responsibilities
• A Treatment Locator can help you find your nearest physician certified in bispecifics from J&J. Certified physicians are HCPs authorized to prescribe and administer certain bispecifics

A ACCC Checklist can be useful in supporting your facility and operational champion with care coordination, ensuring appropriate steps are taken for drug administration, and for patient care. The Association of Community Cancer Centers (ACCC) developed a checklist to help cancer practices and programs adopt the use of bispecific antibodies to treat cancer. Community cancer providers may use the checklist whether their program is referring patients to academic centers or treating patients in-house. Users should refer to the relevant section of the checklist.¹

MOU DetailsTreatment Locator ACCC Checklist

Familiarity with the AR profile of multiple myeloma bispecific therapies is important, including the risks of cytokine release syndrome (CRS), neurologic toxicity, and infections. Additional ARs, both hematologic and non-hematologic, may also occur. Understanding these diverse AR profiles will help you tailor your management protocols effectively.

• Cellular Therapies in Community Oncology: Operational Protocols, including Management Recommendations for CRS/ICANS From the American Oncology Network²
• Consensus for CRS and Neurotoxicity, Including ICANS³
• Consensus Recommendations From an Expert Panel for Monitoring, Prophylaxis, and Treatment of Infections in Patients With MM Receiving Bispecific Antibody Therapy⁴

These programs may offer resources to assist with benefits investigations, prior authorizations, claims appeals, savings programs, and other support resources to help manage your patients’ needs. Additional details regarding manufacturer support programs can be found in the J&J Resource Library.

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