Daratumumab (Darzalex) and Daratumumab and Hyaluronidase-fihj (Darzalex Faspro) (CPB 0904, reviewed 2026-06-08)

By June 8, 2026: Billing team and oncology providers must implement precertification requirements for all daratumumab (Darzalex) and daratumumab/hyaluronidase (Darzalex Faspro) prescriptions. (1) Update billing system to flag ALL daratumumab claims as requiring prior authorization before submission. (2) Train providers to verify medical necessity criteria are met before prescribing—refer to specific combination therapy requirements listed in policy (e.g., for MM: bortezomib+cyclophosphamide+dexamethasone, or lenalidomide+dexamethasone for transplant-ineligible patients). (3) Add precertification contact information (Phone: 866-752-7021; Fax: 888-267-3277) to EMR templates and encounter forms. (4) For systemic light chain amyloidosis continuation therapy, document that 24-month maximum duration applies—track in billing system for reauthorization denials after 24 months. (5) Pharmacy staff must submit Statement of Medical Necessity (SMN) forms via Specialty Pharmacy Precertification portal before dispensing. Failure to obtain precertification will result in claim denials. This policy applies to commercial Aetna plans only; refer to separate Medicare Part B criteria for Medicare beneficiaries.