CurrentAvMedPolicy N/A

Amtagvi (lifileucel) medical prior authorization

Prior authorization form and medical coverage criteria for Amtagvi (lifileucel) administered under the medical benefit (J9999). Defines patient eligibility, clinical exclusion criteria, dosing limits, provider and site requirements, and documentation/submission instructions for approval of a single lifetime treatment course.

Policy Summary

PayerAvMed

PolicyAmtagvi (lifileucel) medical prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionPrescribing physician must sign and clearly print name on the prior authorization request and fax complete information to 1-877-535-1391; incomplete/illegible submissions may delay authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Lifetime doses allowed

18+Minimum member age (years)

>=7.5e9Minimum viable cells per dose

MultipleKey clinical exclusions

Coverage Summary

Prior authorization is required for Amtagvi (lifileucel) administered under the medical benefit (HCPCS J9999). The prior authorization form and medical coverage criteria define patient eligibility, clinical exclusion criteria, dosing limits, provider and site requirements, and documentation/submission instructions for approval of a single lifetime treatment course.

Amtagvi is provided as patient-specific infusion bag(s) with a single-dose, one-time lifetime administration: 1 treatment course (1 dose) per lifetime. The form captures member and prescriber information, clinical eligibility, dosing schedule, and site of administration details necessary for authorization.

Surface thresholds summary

Lifetime doses1 treatment course (1 dose) per lifetime

Minimum member age18 years or older

Minimum viable cells per doseMinimum of 7.5 x 10^9 viable cells per dose

LVEF>= 45% (LVEF must NOT be less than 45%)

NYHA classNYHA functional class <= 1

FEV1> 60% (FEV1 must NOT be <= 60%)

Hemorrhage windowNo hemorrhage grade >=2 within 14 days prior to therapy

Authorization Criteria (All must be met)

All criteria must be met for approval. To support each line checked, documentation (lab results, diagnostics, chart notes) must be provided.

Lifetime dose: One treatment course (1 dose) per lifetime; coverage may NOT be renewed1 treatment course per lifetime
Only a single lifetime dose allowed
Age: Member is 18 years of age and older>= 18 years
Must check box and support with documentation
Provider specialty: Provider requesting therapy is an oncologist, or a dermatologist with consult/specialty in oncology
Diagnosis: Member has a diagnosis of unresectable or metastatic melanoma
Uveal melanoma exclusion: Member does NOT have uveal melanoma
Exclusion
Prior therapies
- Required prior therapies list: Programmed cell death protein-1 (PD-1) blocking antibody; If BRAF V600 mutation-positive, a BRAF inhibitor with or without a MEK inhibitor
Brain metastases exclusion: Member does NOT have uncontrolled brain metastases
Exclusion
Renal exclusion: Member does NOT have signs and symptoms of acute renal failure prior to treatment
Exclusion
Hemorrhage exclusion: Member does NOT have hemorrhage (grade 2 or higher) within 14 days prior to therapyno hemorrhage grade >=2 within 14 days
Temporal exclusion (14 days)
Cardiac function: Member does NOT have a left ventricular ejection fraction (LVEF) less than 45% or New York Heart Association (NYHA) functional classification greater than Class 1LVEF >= 45%; NYHA class <= 1
Cardiac function thresholds
Pulmonary function: Member does NOT have forced expiratory volume in one second (FEV1) of less than or equal to 60%FEV1 > 60%
Pulmonary function threshold
Active infection exclusion: Member does NOT have a clinically significant active systemic infection
Active infection exclusion
IL-2 eligibility: Member is deemed eligible for IL-2 (aldesleukin) therapy according to the manufacturer's prescribing label
Eligibility for IL-2 per label required
No prophylactic steroids: Member will NOT receive concomitant prophylactic systemic corticosteroid therapy
No concomitant prophylactic systemic corticosteroids

Provider Actions & Submission Requirements

Prior Authorization

Submit signed prior authorization request

Prescribing physician must sign and clearly print name on the prior authorization request and fax complete information to 1-877-535-1391. Incomplete, incorrect, or illegible submissions may delay authorization.

Documentation Required

Support each criterion with documentation

All documentation, including laboratory results, diagnostics, and chart notes, must be provided to support each clinical criterion checked on the authorization form. Failure to provide required documentation may result in denial or delay of the request.

Lab results
Diagnostic reports
Chart notes / clinical documentation

Documentation Required

Provider specialty requirement

Ensure the requesting provider is an oncologist, or a dermatologist with an oncology consult or oncology specialty documented on the request form.

Billing Rule

Dose and dispensing limits

Dose and dispensing limits: Amtagvi is a single lifetime treatment (one treatment course, one dose per lifetime). Product NDC 73776-0001-xx describes Amtagvi as 7.5 x 10^9 to 72 x 10^9 viable cells suspended in 1 to 4 patient-specific infusion bag(s). Use HCPCS code J9999 for medical benefit billing. Note that the product may be provided in 1–4 patient-specific infusion bags and should be billed on the medical benefit.

Single lifetime dose allowed (1 treatment course)
Product NDC: 73776-0001-xx
HCPCS: J9999
Contains 1 to 4 patient-specific infusion bags; bill under medical benefit

Prior Authorization

Urgent review process

For urgent review requests—where lack of treatment could seriously jeopardize life, health, or the member’s ability to regain maximum function—the practitioner should call the AvMed Pre-Authorization Department to request an urgent review.

Background

Amtagvi (lifileucel) is a cell therapy product supplied in patient-specific infusion bag(s) and administered as a single-dose, one-time lifetime therapy. The product is represented on the form as Amtagvi (lifileucel) for medical benefit billing.

The prior authorization form collects details to document clinical eligibility, dosing and dosing limits (including number of infusion bags and viable cell counts), and the provider/site of administration. The form requires the prescribing physician's signature and provider contact information; incomplete or illegible submissions may delay authorization.

Treatment course is defined as 1 dose (single administration) of Amtagvi per lifetime.

Clinical Evidence & Metrics

All authorization criteria must be met and supported with documentation (lab results, diagnostics, chart notes). Key clinical prerequisites include: patient age of 18 years or older; diagnosis of unresectable or metastatic melanoma (excluding uveal melanoma); administration by an oncologist or a dermatologist with oncology consult/specialty; prior therapy with a PD-1 blocking antibody (and if BRAF V600 mutation-positive, prior BRAF inhibitor with or without a MEK inhibitor); and eligibility for IL-2 (aldesleukin) per the manufacturer's prescribing label.

Important exclusions and clinical thresholds that must be met prior to treatment include: only a single lifetime dose allowed; no uncontrolled brain metastases; no clinically significant active systemic infection; no hemorrhage grade ≥2 within 14 days prior to therapy; cardiac function thresholds of LVEF not less than 45% and NYHA class ≤ 1; and pulmonary threshold of FEV1 > 60%. Concurrent prophylactic systemic corticosteroids should not be given.

Clinical thresholds (detailed)

LVEF>= 45% — Member must NOT have LVEF less than 45%

NYHA classNYHA functional class <= 1 — Member must NOT be greater than Class 1

FEV1> 60% — Member must NOT have FEV1 <= 60%

Hemorrhage windowNo hemorrhage (grade 2 or higher) within 14 days prior to therapy

Minimum viable cells per doseSingle dose must contain a minimum of 7.5 x 10^9 viable cells