Dinutuximab (Unituxin) (CPB 0895, reviewed 2025-10-23)

By 2025-10-23: Billing team must implement this policy in claim processing systems. (1) Update prior authorization (PA) rules to REQUIRE approval for dinutuximab claims ONLY when ALL of the following documented criteria are met: patient age <21 years, high-risk neuroblastoma diagnosis (ICD-10 C74.00-C74.92), and one of three approved clinical scenarios (post-consolidation maintenance with sargramostim/isotretinoin; chemoimmunotherapy with temozolomide/irinotecan/sargramostim for minor/stable/progressive disease; or progressive disease post-consolidation). (2) Configure system to DENY or REQUEST MEDICAL RECORDS REVIEW for all other cancer indications (Ewing sarcoma, glioblastoma multiforme, small cell lung cancer, osteosarcoma, triple-negative breast cancer) with explanation 'experimental/investigational per CPB 0895.' (3) Attach PA requirement to CPT codes 96365, 96366, 96401-96450 and HCPCS codes J2820, J9015, J9328 when linked to dinutuximab treatment. (4) Educate oncology providers that continuation beyond 5 cycles requires new PA with documentation of absence of unacceptable toxicity or disease progression. (5) Update claim edits to reject or pend dinutuximab claims for patients age 21+ years. Failure to implement will result in claim denials and member appeals.