We know your goal is to provide the best care possible for your patients.

All healthcare providers (HCPs) involved in prescribing RRMM 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.

Additionally, they must complete and provide patients or their caregivers with the Patient Wallet Card. Additional REMS certification details are available in our 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 RRMM, including efficacy and safety, dosing considerations, infection prophylaxis, pretreatment for adverse reactions (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/rehospitalization, 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.²

MOU DetailsTreatment Locator ACCC Checklist

Familiarity with the AR profile of RRMM 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.

Consensus Recommendations

• Consensus for Cytokine Release Syndrome (CRS) and Neurotoxicity, Including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)³
• Consensus Recommendations From an Expert Panel for Monitoring, Prophylaxis, and Treatment of Infections in Patients With MM Receiving Bispecific Antibody Therapy⁴
• International Myeloma Working Group (IMWG) Consensus Guidelines⁵

Sample Protocol Resources*

• Bispecific T-Cell Engager Neurotoxicity Management (Academic Medical Center)⁷
• Bispecific T-Cell Engager Neurotoxicity Management (Large Community Cancer Clinic)⁸
• Bispecific T-Cell Engager Neurotoxicity Management (Mid-sized, Rural Community Cancer Clinic)⁹
• Cellular Therapies in Community Oncology: Operational Protocols, Including Management Recommendations for CRS/ICANS From the American Oncology Network¹⁰
• On-Call Symptom Interventions for Patients Receiving Bispecific T-Cell Engagers (Mid-sized, Community Cancer Clinic)¹¹
• Telephone Triage of Patients Undergoing Bispecific T-Cell Engager Therapy (Mid-sized, Community Cancer Clinic)¹²

*The links to resources above may contain data, conclusions, and recommendations that do not conform to the FDA-approved labeling for bispecific therapies from Johnson & Johnson. The opinions expressed in the links above do not necessarily reflect those of Johnson & Johnson. Bispecific therapies from Johnson & Johnson should be used only as specified in the Prescribing Information. Please see full Prescribing Information in the Resource Library tab.

FDA, U.S. Food and Drug Administration.​

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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