Lifileucel (Amtagvi) — Coverage Criteria
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Governs coverage criteria and authorization requirements for lifileucel (Amtagvi) IV infusion for adults with unresectable or metastatic melanoma who meet specified clinical and safety criteria; applies to Blue Cross NC members.
Added revenue codes 0891 and 0892 associated with policy HCPCS code(s).
Added distribution channel management language indicating specialty pharmacy distribution may be required for certain gene and cellular therapies.
Coverage Criteria for Lifileucel (Amtagvi)
Initial therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
medical record documentation required
medical record documentation required; excludes uveal/ocular melanoma
medical record documentation required
medical record documentation required
medical record documentation required when applicable
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
medical record documentation required
documentation of planned dosage required
Coverage for lifileucel (Amtagvi) explicitly excludes patients with uveal or ocular melanoma. The policy requires medical record documentation confirming the melanoma subtype to verify that the diagnosis is not uveal or ocular prior to approval.
The policy supports only a single treatment course per lifetime and specifies a maximum of 1 unit (one treatment course). Treatment that would exceed this single lifetime course or otherwise exceed the maximum units is not supported by the policy.
| Regimen | Dose / Units | Treatment course | Coverage stance |
|---|---|---|---|
| Lifileucel (Amtagvi) IV infusion with lymphodepleting chemotherapy and IL-2 support | |||
| 7.5 x 10^9 to 72 x 10^9 viable cells | |||
| Maximum units = 1 (one treatment course per lifetime); Duration of approval: 180 days | |||
| Covered when criteria are met (see coverage criteria) |
Coding and Billing Codes
| 0891 | Special Processed Drugs - FDA Approved Cell Therapy (revenue code) |
| 0892 | Special Processed Drugs - FDA Approved Gene Therapy (revenue code) |
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required; applicable HCPCS and coordination
Prior authorization is required for lifileucel (Amtagvi) intravenous infusion. Applicable HCPCS/miscellaneous drug codes listed in the policy are C9399, J3490, J3590, and J9999. Coordination with Blue Cross NC may be required for specialty pharmacy distribution for certain gene and cellular therapies.
Required prior systemic therapy (PD‑1 and BRAF V600 considerations)
Patient must have experienced disease progression after treatment with a PD-1 blocking antibody. If the patient is BRAF V600 mutation-positive, the patient must have tried and had an inadequate response to a BRAF inhibitor with or without a MEK inhibitor.
- Progression despite prior PD-1 blocking antibody is required
- If BRAF V600-positive, prior trial of a BRAF inhibitor ± MEK inhibitor with inadequate response is required
Required medical record documentation (diagnosis, exclusions, prior therapies, lymphodepletion/IL‑2)
Medical record documentation must demonstrate: diagnosis of unresectable or metastatic melanoma and absence of uveal/ocular melanoma; prior PD-1 therapy and, if BRAF V600-positive, prior BRAF inhibitor use; receipt of or plan for lymphodepleting chemotherapy prior to infusion; and eligibility for IL-2 (aldesleukin) therapy. Documentation should also include planned cell dose not to exceed 72 x 10^9 viable T cells and evidence of cardiac, pulmonary, renal, infection, and neurologic status per policy criteria.
- Diagnosis of unresectable or metastatic melanoma and exclusion of uveal/ocular melanoma
- Prior PD‑1 therapy (and prior BRAF inhibitor use if BRAF V600‑positive)
- Receipt of or plan for lymphodepleting chemotherapy prior to infusion
- Eligibility for IL‑2 (aldesleukin) therapy
- Planned dose documentation (must not exceed 72 x 10^9 viable T cells)
- Documentation of LVEF, FEV1, absence of acute renal failure, absence of clinically significant active systemic infection, and no recent grade ≥2 hemorrhage
Documentation-based denial risks
Claims or prior authorization requests may be denied if medical records do not document patient age, diagnosis, prior PD-1 therapy, prior BRAF inhibitor trial when BRAF V600‑positive, planned or received lymphodepleting chemotherapy, or eligibility for IL-2; missing evidence of exclusions and organ function criteria may also trigger denial.
- Missing documentation of patient age (≥18 years) or diagnosis of unresectable/metastatic melanoma
- Absent documentation confirming no uveal/ocular melanoma
- No documentation of disease progression after PD‑1 blocking antibody
- No documentation of prior BRAF inhibitor trial when BRAF V600 mutation‑positive
- No documentation of lymphodepleting chemotherapy plan/receipt or IL‑2 eligibility
- Missing documentation of required cardiac, pulmonary, renal, infection, or hemorrhage status
Line of Therapy / Salvage Use
Salvage
If BRAF V600-positive, prior BRAF inhibitor tried and inadequate response required
Biomarker and Mutation Requirements
Definitions and Supportive Therapy
Background
Lifileucel (Amtagvi) is an autologous tumor-infiltrating lymphocyte (TIL) cell therapy indicated for adults with unresectable or metastatic melanoma after prior PD-1 blockade. Administration requires lymphodepleting chemotherapy and eligibility for subsequent IL-2 (aldesleukin) support, and the patient must meet multiple clinical and safety criteria documented in the medical record (for example, no uncontrolled brain metastases, adequate cardiac and pulmonary function, no active systemic infection, and no prior genetically modified T cell therapy). The FDA-approved dose range is 7.5 x 10^9 to 72 x 10^9 viable cells, with a planned treatment cap of ≤ 72 x 10^9 viable T cells, and duration of approval is 180 days (one treatment course per lifetime).
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