Prademagene Zamikeracel (Zevaskyn) (CPB 1084, reviewed 2026-05-27)

By 2026-05-27: (1) Billing and authorization teams must implement precertification requirement for J3389 (Zevaskyn topical administration). Direct all requests to Aetna at (866) 752-7021 or fax (888) 267-3277 using Statement of Medical Necessity forms available at Specialty Pharmacy Precertification. (2) Update billing system to enforce one-dose-per-wound limitation and prevent duplicate billing for the same wound. (3) Verify all Zevaskyn claims route through Aetna Institutes GCIT Designated Networks only; claims from non-network facilities will be denied. (4) Providers must document in clinical records: patient age (6+), genetic confirmation of biallelic COL7A1 variants, NC1+ protein expression testing, wound stage (≥2 chronic, open 6+ months), absence of squamous cell carcinoma history, no active infection, and confirmation wound is not previously treated and not currently healed. (5) Update provider ordering workflows to require dermatology or wound care specialist involvement before authorization. (6) Create denial management rules to flag and reject claims that fail to meet any eligibility criterion listed in Criteria for Initial Approval section. (7) Cross-reference against related policies (CPB 1033 for Vyjuvek, CPB 1087 for NexoBrid) to ensure appropriate therapy sequencing—note member cannot receive Vyjuvek or Filsuvez on wounds previously treated with Zevaskyn.