Daratumumab (Darzalex®)

By October 31, 2026: Billing team and prior authorization staff must implement this new Daratumumab (Darzalex®) policy in the prior authorization system and billing software. Specific actions required: (1) Create prior authorization rules in the billing system requiring approval before claims can be processed for any Daratumumab claims for BCBS Tennessee members; (2) Configure the system to verify that all coverage criteria are met based on diagnosis, patient history (transplant eligibility, prior therapies, refractory status), and specific drug combinations; (3) Require documentation of t(11:14) translocation testing when applicable to the requested regimen; (4) Set up medication quantity limit edits for each indication (Multiple Myeloma/POEMS/MIDD/MGRS at 16mg/kg per dose; HIV-related B-cell lymphomas at 16mg/kg weekly x9 then every 3 weeks x3; Systemic Light Chain Amyloidosis at 16mg/kg weekly x8, then every 2 weeks x8, then every 4 weeks; T-ALL at 16mg/kg weekly x8, then every 2 weeks x8, then every 4 weeks); (5) Train providers and billing staff on the approval criteria for each indication and prior therapy requirements; (6) Obtain verification from providers regarding disease stage, prior treatment history, and refractoriness status at time of authorization request. Providers must document all required clinical information on prior authorization requests. Failure to obtain prior authorization or meet coverage criteria will result in claim denials for BCBS Tennessee members.