CommercialPrior AuthHigh impact
Lifileucel (Amtagvi) (CPB 1056, reviewed 2026-04-08)
Aetna·Oncology, Dermatology, Hematology·Medical Policy
Effective date
Apr 8, 2026
We identified it
Aug 16, 2026
Summary
Aetna has established a new medical policy (CPB 1056) for lifileucel (Amtagvi), a tumor-derived autologous T cell immunotherapy for unresectable or metastatic melanoma. The policy requires precertification for all commercial plans, mandates administration at Aetna Institutes GCIT Network facilities, and specifies strict clinical criteria including prior PD-1 inhibitor and BRAF inhibitor treatment, adequate organ function, ECOG performance status 0-1, and exclusion of uveal/ocular melanoma and uncontrolled brain metastases. Billing teams must implement prior authorization workflows and ensure claims are routed only for eligible patients meeting all specified criteria.
Action Required
IMMEDIATE - By April 8, 2026: (1) Billing team must implement mandatory precertification requirement for lifileucel (Amtagvi) in billing system by contacting National Medical Excellence (NME) at 877-212-8811 before claim submission. (2) Update encounter forms and billing workflows to verify ALL clinical criteria are met before processing claims: patient age ≥18, prior PD-1 inhibitor treatment (CPT J9271/J9299), prior BRAF inhibitor (if BRAF V600 mutation positive per CPT 81210), no prior lifileucel treatment, no uveal/ocular melanoma (exclude ICD-10 C69.30-C69.42), no uncontrolled brain metastases, no prior organ allograft except kidney (exclude Z94.89), adequate organ function documented via CPT 80069 (renal), CPT 94150/94375/94618/94726 (pulmonary/cardiac), ECOG performance status 0 or 1 documented, no clinically significant active infection. (3) Coding staff must ensure lifileucel claims are only submitted with ICD-10 codes C43.0-C43.9 (cutaneous melanoma only); deny or reject any claims with uveal/ocular melanoma or allograft history codes. (4) Providers must route all lifileucel administrations through Aetna Institutes GCIT Designated Networks only; verify facility compliance before claim entry. (5) Update billing software rules to flag and require manual review for any lifileucel claims missing precertification authorization. Failure to obtain precertification or process claims outside GCIT network will result in claim denials. This is a newly approved gene therapy requiring specialized handling and network compliance.