Darzalex Faspro™ (daratumumab and hyaluronidase-fihj) (Revised)

By March 25, 2026 (current revision date): Billing team must immediately implement prior authorization requirements for all Darzalex Faspro (daratumumab and hyaluronidase-fihj) claims across Medicare, Medicaid-Florida, Medicaid-Kentucky, and Medicaid-South Carolina plans. Before submitting any claim: (1) Verify member meets ALL required criteria for one of three indications (multiple myeloma, light chain amyloidosis, or high-risk smoldering multiple myeloma); (2) Confirm prescribed regimen matches policy-approved combination therapy or monotherapy requirements; (3) For multiple myeloma monotherapy, document member has received at least 3 prior lines of therapy including both a proteasome inhibitor and immunomodulatory drug, OR is double-refractory to both drug classes; (4) For light chain amyloidosis, rule out NYHA Class IIIB/IV or Mayo Stage IIIB cardiac disease; (5) Confirm member does not have documented disease progression while on daratumumab (automatic exclusion); (6) Submit prior authorization requests with complete clinical documentation including diagnosis, prior treatment history, and current regimen details. Update billing software rules to flag all Darzalex Faspro claims for mandatory prior auth before transmission. Providers must document medical justification on prescriptions. Billing team responsible for prior auth submission. Consequences: Claims denied without prior authorization; resubmission delays treatment; potential member out-of-pocket costs.