Commercial

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member's medical needs and condition.

MEDICALLY NECESSARY

Lifileucel (Amtagvi) as a component of tumor-infiltrating lymphocyte (TIL) therapy is considered medically necessary and, therefore, covered in adult individuals with unresectable or metastatic melanoma* and all of the following: 

• as second-line or subsequent systemic therapy** as National Comprehensive Cancer Network (NCCN)-preferred therapy after progression on both
• PD-1 blocking antibody (e.g., Keytruda, Opdivo) and
• BRAF inhibitor (e.g., Braftovi, Tafinlar, Zelboraf) with or without a MEK inhibitor (e.g., Cotellic, Mekinist, Mektovi) if BRAF V600 mutation positive.
• Eastern Cooperative Oncology Group (ECOG) performance status score of PS 0 or 1 
• The individual has at least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter, postresection, to generate cell therapy
• The individual has adequate and stable kidney, pulmonary and cardiac function
• The individual does not have clinically significant active systemic infection
• The individual does not have uncontrolled brain metastasis
• The individual does not have uveal or ocular melanoma
• The individual does not have a history of prior cell transfer therapy

​Note: one-time lifileucel TIL cell therapy.

*Metastatic disease includes stage III unresectable/borderline resectable disease with clinically positive node(s) or clinical satellite/in-transit metastases, or as well as unresectable/borderline resectable local satellite/in-transit recurrence, unresectable nodal recurrence, and widely disseminated distant metastatic disease.
**Systemic therapy is preferred for unresectable or widely disseminated distant metastatic disease.

MANDATES

PENNSYLVANIA MEMBERS

In accordance with the Commonwealth of Pennsylvania's Act 6 of 2020 or Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive Agents" (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.

EXPERIMENTAL/INVESTIGATIONAL

All other uses for lifileucel​ (Amtagvi) not identified in this policy are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the Company medical policy on off-label coverage for prescription drugs and biologics. 

NOT ELIGIBLE FOR SEPARATE REIMBURSMENT

The harvesting and preparation of blood-derived T lymphocytes and the receipt and preparation of T cells are not eligible for separate reimbursement from the TIL administration.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug. ​