An operational champion is your facility representative who supports and coordinates the multiple myeloma bispecific administration process between your care team, site(s) of care, and patient. The designated operational champion does not need to complete each step themselves, rather, they support the communication and coordination efforts during the patient treatment journey.

Potential responsibilities may include:

• Coordinating among the multidisciplinary team
• Facilitating the REMS process
• Supporting care coordination between facilities for patients receiving initiation and maintenance therapy at different locations

The FDA has determined that a REMS is necessary for all pharmacies and healthcare settings involved in dispensing bispecific therapies for multiple myeloma to ensure that the benefits outweigh the associated risk of serious toxicities. REMS enrollment for J&J products can be completed in four steps; details are available in our J&J Resource Library.

J&J REMS Enrollment Details

The FDA may require audits to evaluate compliance with REMS requirements.¹ Developing standardized documentation processes consistent with your organizational procedures can help ensure preparedness for a potential audit; details are available in our J&J Resource Library.

SOPs and treatment protocols are essential resources that guide staff in educating and training, coordinating care, defining roles and responsibilities, managing adverse reactions (ARs), and more.^2,3 Establishing consistent approaches to treating multiple myeloma patients with bispecifics can enhance operational excellence across your facility. While SOPs may vary depending on the site and organizational needs, they typically include details such as:

• Training frequency
• Internal collaboration and/or treatment partnerships
• Drug-specific protocols
• AR management algorithms, including admission criteria and hospitalization procedures
• Product management, including distribution, transfer, loan, and sale

Financial and economic factors are vital for supporting your organization’s financial goals. Various elements should be taken into consideration, including:

• Product coverage, such as product formulary status, payer requirements, and prior authorization (PA) needs
  • A Prior Authorization Checklist can be helpful to ensure your facility has the necessary information to submit a PA for your patient.
• Product cost, including the product wholesale acquisition cost (WAC), applicable discounts and/or rebates, availability of New Technology Add-on Payment (NTAP), and any associated cost implications from treatment site of administration
• Coding, the appropriate codes for site of care, applicable product pass-through status, and product J-codes (if available)

Download Prior Authorization Checklist