CurrentViva Health PlanPolicy IC-0748

Amtagvi (lifileucel) Intravenous Therapy

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This policy governs prior authorization and coverage of one treatment course of intravenous Amtagvi (lifileucel) for adults with unresectable or metastatic cutaneous melanoma. Coverage requires clinical safety, treatment-history, and documentation requirements.

Policy Summary

PayerViva Health Plan

PolicyAmtagvi (lifileucel) Intravenous Therapy

Policy CodePolicy IC-0748

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for one Amtagvi treatment course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseInitial authorization treatment course

No renewalRenewal authorization availability

72 x 10^9Maximum cells per dose

18+Minimum member age

C43.x

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CurrentViva Health PlanPolicy IC-0748

Amtagvi (lifileucel) Intravenous Therapy

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Sign up for vivahealthplan Policy IC-0748 alerts

Get alerted when Policy IC-0748 changes without checking for updates manually.

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Policy Summary

PayerViva Health Plan

PolicyAmtagvi (lifileucel) Intravenous Therapy

Policy CodePolicy IC-0748

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for one Amtagvi treatment course.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseInitial authorization treatment course

No renewalRenewal authorization availability

72 x 10^9Maximum cells per dose

18+Minimum member age

C43.x

Covered diagnosis code family

Coverage Criteria

Initial Therapy — Cutaneous Melanoma

Covered when ALL of the following are met:

ALL of the following

Member is at least 18 years of age.
Member is deemed eligible for IL-2 (aldesleukin) therapy.
Member has a diagnosis of unresectable or metastatic cutaneous melanoma.
Treatment is used as subsequent therapy after a programmed cell death protein-1 (PD-1) blocking antibody.
If the melanoma is BRAF V600 mutation-positive, treatment is used after a BRAF inhibitor with or without a MEK inhibitor.

Renewal Limitation

Renewal is not available.

Renewal limitation

Prior authorization validity may not be renewed.
Authorization is limited to one treatment course (1 dose); the duration of authorization may not be exceeded.

Submission of supporting clinical documentation, including medical records, chart notes, laboratory results, and confirmatory diagnostics, is required for all authorization requests. Documentation must support the diagnosis, step therapy, and applicable clinical markers, including genetic and mutational testing. Records must be submitted by direct upload through the prior authorization web portal or by fax; failure to submit medical records may result in denial because medical necessity cannot be established.

The member must not have uncontrolled brain metastases, signs or symptoms of acute renal failure before treatment, hemorrhage (grade 2 or higher) within 14 days before therapy, a left ventricular ejection fraction (LVEF) less than 45%, New York Heart Association (NYHA) functional classification greater than Class 1, forced expiratory volume in one second (FEV1) less than or equal to 60%, or a clinically significant active systemic infection.

The member will not receive concomitant prophylactic systemic corticosteroid therapy.

The member must not have uveal melanoma.

Coding and Clinical Parameters

HCPCS Code(s)HCPCS

J9999	Not otherwise classified, antineoplastic drug
C9399	Unclassified drugs or biologics

NDC(s)NDC

73776-0001-xx

Amtagvi contains 7.5 x 10^9 to 72 x 10^9 viable cells suspended in 1 to 4 patient-specific infusion bags

Covered Diagnosis CodesICD-10Covered

C43.0	Malignant melanoma of lip
C43.10	Malignant melanoma of unspecified eyelid, including canthus
C43.111	Malignant melanoma of right upper eyelid, including canthus
C43.112	Malignant melanoma of right lower eyelid, including canthus
C43.121	Malignant melanoma of left upper eyelid, including canthus
C43.122	Malignant melanoma of left lower eyelid, including canthus
C43.20	Malignant melanoma of unspecified ear and external auricular canal
C43.21	Malignant melanoma of right ear and external auricular canal
C43.22	Malignant melanoma of left ear and external auricular canal
C43.30	Malignant melanoma of unspecified part of face

1–10 of 24

1/3

Age Requirement

Minimum ageAt least 18 years of age

Eligibility requirementThe member must be an adult before treatment authorization

Coverage conditionAge 18 or older is required for Amtagvi authorization

Left Ventricular Ejection Fraction

Minimum LVEF45%

Required thresholdLeft ventricular ejection fraction must not be less than 45%

Exclusion threshold

Provider Requirements and Authorization Rules

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for Amtagvi® (lifileucel) and, if approved, is valid initially for one treatment course consisting of one dose.

Submit the authorization request before treatment.
Initial authorization is limited to one treatment course (1 dose).

Denial Risk

No Renewal Authorization

Prior authorization validity may not be renewed. Providers should not submit renewal requests for additional Amtagvi treatment courses.

No renewal authorization is permitted.
The duration limitation in Section I applies to the authorization.

Unsupported block type: step_therapy

Therapy Background

Amtagvi (lifileucel) is an autologous, tumor-derived tumor-infiltrating lymphocyte cell therapy for eligible adults with unresectable or metastatic cutaneous melanoma. It is administered as a single intravenous dose after lymphodepleting chemotherapy; subsequent inpatient intravenous IL-2 (aldesleukin) supports in-vivo cell expansion.

Definitions

Unresectable or Metastatic Melanoma

Unresectable melanomaMelanoma that cannot be removed surgically

Metastatic melanomaMelanoma that has spread to distant sites

Covered disease contextThe policy covers unresectable or metastatic cutaneous melanoma

Uveal Melanoma

DefinitionMelanoma arising from the uveal tract of the eye

Policy statusUveal melanoma is excluded from coverage

Covered indication distinctionThe covered disease is unresectable or metastatic cutaneous melanoma, not uveal melanoma

Initial Amtagvi Authorization

Continuation and Renewal

No renewal therapy

No continuation or renewal authorization is available.

One-time treatment limit: Amtagvi is authorized for one treatment course consisting of one dose, and prior authorization may not be renewed.1 dose per treatment course

The renewal criteria do not provide authorization for continuation or another treatment course.

Required Prior Treatment

Step	Required prior therapy	Additional requirement
1	Treatment with a programmed cell death protein-1 (PD-1) blocking antibody is required before Amtagvi.	For BRAF V600 mutation-positive melanoma, prior treatment with a BRAF inhibitor, with or without a MEK inhibitor, is also required.

Amtagvi Quantity Limits

Amtagvi (lifileucel)

Treatment courseOne single dose per treatment course

Maximum dose72 x 10^9 viable cells

Infusion bagsThe dose may be supplied in one or more member-specific infusion bags

Administration Site and Related Therapy

Note

Administer post-infusion IL-2 under supervision

Beginning 3 to 24 hours after the Amtagvi infusion, administer intravenous IL-2 (aldesleukin) at 600,000 IU/kg every 8 to 12 hours for up to a maximum of 6 doses. IL-2 should be administered in an inpatient setting under the supervision of a physician experienced in its use.

Policy Summary

PayerViva Health Plan

PolicyAmtagvi (lifileucel) Intravenous Therapy

Policy CodePolicy IC-0748

Change TypeNo material change

Effective DateN/A

Last ReviewOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for one Amtagvi treatment course.

SourceLink

On This Page

LVEF less than 45% does not meet the coverage criteria

NYHA Functional Classification

Maximum NYHA classClass 1

Required classificationNYHA functional classification must not be greater than Class 1

Exclusion thresholdNYHA functional classification greater than Class 1 does not meet the coverage criteria

Forced Expiratory Volume in One Second

Minimum FEV1Greater than 60%

Required thresholdForced expiratory volume in one second must be greater than 60%

Exclusion thresholdFEV1 of less than or equal to 60% does not meet the coverage criteria

Recent Hemorrhage

Hemorrhage timingWithin 14 days before therapy

Excluded eventGrade 2 or higher hemorrhage

Coverage requirementThe member must not have had a grade 2 or higher hemorrhage within 14 days before therapy

Amtagvi Viable-Cell Dose

Maximum viable-cell quantity72 x 10^9 viable cells per dose

Dose rangeEach dose contains 7.5 x 10^9 to 72 x 10^9 viable cells

Infusion packagingThe dose is supplied in one or more member-specific infusion bags

Documentation Required

Medical Necessity Records Required

Submit supporting clinical documentation with every authorization request. Records are reviewed at submission to evaluate medical necessity.

Medical records and chart notes
Laboratory results
Confirmatory diagnostic results
Upload documentation directly through the prior authorization web portal or submit it by fax

Documentation Required

Diagnosis and Treatment-History Documentation

Include documentation supporting the diagnosis, required step therapy, and clinical markers relevant to treatment initiation when applicable.

Diagnosis documentation for unresectable or metastatic melanoma
Documentation of prior PD-1 therapy and, when applicable, BRAF-directed therapy
Genetic and mutational testing results or other clinical-marker documentation

Documentation Required

Clinical Eligibility Evidence

Clinical records must establish that the member meets the age, disease-status, safety, and treatment-eligibility requirements for Amtagvi and IL-2 (aldesleukin) therapy.

Member is at least 18 years of age.
Member has no uncontrolled brain metastases.
Member is eligible for IL-2 (aldesleukin) therapy.
Document cardiac, pulmonary, renal, hemorrhage, infection, and corticosteroid-related eligibility as applicable.

Denial Risk

Missing Supporting Documentation

Failure to submit the required medical records and supporting evidence may result in denial because medical necessity cannot be established in accordance with policy guidelines.

Submit all records needed to evaluate the medical necessity criteria with the request.
Incomplete documentation may prevent authorization.

Denial Risk

Safety or Eligibility Exclusions

Authorization is not available when a specified safety or eligibility exclusion is present.

Uncontrolled brain metastases
Signs or symptoms of acute renal failure before treatment
Hemorrhage of grade 2 or higher within 14 days before therapy
LVEF less than 45% or NYHA functional classification greater than Class 1
FEV1 less than or equal to 60%
Clinically significant active systemic infection
Ineligibility for IL-2 (aldesleukin) therapy
Concomitant prophylactic systemic corticosteroid therapy

Denial Risk

Uncovered Indication or Inadequate Prior Therapy

Amtagvi is not authorized for an uncovered indication or when required prior therapy has not been completed and documented.

Uveal melanoma is excluded.
The member must have unresectable or metastatic melanoma.
Authorization may be denied when required prior PD-1 therapy is insufficient or undocumented.
For BRAF V600 mutation-positive disease, required prior BRAF inhibitor therapy with or without a MEK inhibitor must be completed and documented.

Billing Rule

Authorization Limit Exceeded

The authorization limit is one treatment course and one dose. Once that course has been authorized, the authorization may not be renewed for additional treatment.

Maximum authorized course: 1 treatment course.
Maximum authorized dose: 1 dose.
Renewal or extension for another course is not permitted.

Lymphodepleting Chemotherapy

RegimenCyclophosphamide 60 mg/kg IV with mesna daily for 2 days, followed by fludarabine 25 mg/m^2 IV daily for 5 days

SequenceThe lymphodepleting chemotherapy is administered before Amtagvi infusion

Amtagvi infusion timingInfuse Amtagvi after 24 hours have elapsed following the last fludarabine dose, but no later than 4 days