ModifiedCignaPolicy IP0625

Oncology (Injectable) - Amtagvi

Defines Cigna medical-benefit coverage criteria, dosing, authorization, and coding for a single-dose autologous T-cell therapy (Amtagvi) for adults with unresectable or metastatic melanoma previously treated with PD-1/PD-L1 therapy and, if BRAF V600 mutation positive, BRAF inhibitor ± MEK inhibitor.

Policy Summary

PayerCigna

PolicyOncology (Injectable) - Amtagvi

Policy CodePolicy IP0625

Change TypeNew policy (6/15/2024); annual revision (5/1/2025) — no criteria changes

Effective DateJun 15, 2024

Next Review Date

Key ActionPrior Authorization is required for Amtagvi; approval duration is 6 months to allow preparation and administration of one dose.

POLICY UPDATE CHANGES

New policy created for Amtagvi.

Annual revision performed with no criteria changes.

1Dose per patient approved

18+Minimum patient age

6Approval duration (months)

PD-1 ± BRAF-targetedRequired prior therapies

Coverage Summary

Overview: This policy defines Cigna medical-benefit coverage for Amtagvi (lifileucel), an autologous tumor-derived T‑cell immunotherapy for adults with unresectable or metastatic melanoma who have previously received a PD‑1/PD‑L1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. Coverage stance: covered with criteria — approval is for a single IV infusion when all clinical criteria are met. Dosing summary: Amtagvi is supplied as a single IV infusion containing 7.5 x 10^9 to 72 x 10^9 viable autologous tumor‑derived T cells administered after lymphodepleting chemotherapy. Prior authorization and specialist prescriber requirements apply.

Medical-Necessity Criteria

Medically Necessary - Single Dose Amtagvi

Approve a single dose if the patient meets ALL of the following (A, B, C, D, E, F, and G):

ALL of the following

Patient is ≥ 18 years of age.
Patient has unresectable or metastatic disease.
Patient has been treated with a programmed death receptor-1 (PD-1) blocking antibody or a programmed death-ligand 1 (PD-L1) blocking antibody.
Examples include pembrolizumab, nivolumab, atezolizumab per policy note.
If BRAF V600 mutation positive
- If the patient is BRAF V600 mutation positive, the patient has been treated with a BRAF inhibitor with or without a MEK inhibitor.
  Examples of BRAF inhibitors: encorafenib, vemurafenib, dabrafenib.
Patient has received or is planning to receive lymphodepleting chemotherapy prior to infusion of Amtagvi.
Lymphodepleting chemo defined as cyclophosphamide 60 mg/kg IV with mesna for 2 days and fludarabine 25 mg/m2 IV daily for 5 days (per definitions).
Patient has NOT been previously treated with Amtagvi.
The medication is prescribed by or in consultation with an oncologist (physician who specializes in the condition being treated).
Prior authorization and specialist prescriber requirement apply; approval duration 6 months to allow preparation and administration of one dose.

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Not Medically Necessary / Exclusions

Amtagvi for any other use is considered not medically necessary.

Any indication not meeting the above criteria.

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical benefit coverage of Amtagvi. Approval duration: 6 months to allow preparation and administration of one dose.

Documentation Required

Specialist Prescriber Requirement

Amtagvi must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Documentation Required

Lymphodepletion Requirement

Documentation that the patient has received or is planning to receive the specified lymphodepleting chemotherapy prior to Amtagvi infusion is required: cyclophosphamide 60 mg/kg IV with mesna for 2 days followed by fludarabine 25 mg/m2 IV daily for 5 days.

Billing Rule

Single-Dose Administration

Amtagvi is supplied and covered as a single-dose intravenous infusion. Affected procedure/drug codes: C9399 and J3590. Single administration dose range: 7.5 x 10^9 to 72 x 10^9 viable autologous tumor-derived T cells.

Denial Risk

Prior Treatment and Indication

Claims will be denied when criteria are not met, including: patient age <18 years; disease not unresectable or metastatic; no prior PD-1/PD-L1 therapy; if BRAF V600 mutation positive and no prior BRAF-targeted therapy (with or without MEK inhibitor); or prior treatment with Amtagvi.

Documentation Required

Site and Storage

Amtagvi is autologous and supplied in frozen infusion bags stored in the vapor phase of liquid nitrogen (≤ -150°C). Documentation of appropriate handling, storage, and administration site may be required.

Background & Evidence

Background: Amtagvi is indicated for unresectable or metastatic melanoma in adults previously treated with a PD‑1 blocking antibody (and if BRAF V600 positive, treated with a BRAF inhibitor ± MEK inhibitor). The therapy is provided as a single‑dose IV infusion supplied in one or more frozen infusion bags containing between 7.5 x 10^9 and 72 x 10^9 viable cells, stored at ≤ −150°C. Administration is after lymphodepleting chemotherapy; lymphodepleting chemotherapy is defined as cyclophosphamide 60 mg/kg IV with mesna for 2 days followed by fludarabine 25 mg/m2 IV daily for 5 days, given prior to Amtagvi infusion.

Definitions

Lymphodepleting chemotherapyCyclophosphamide 60 mg/kg IV with mesna for 2 days followed by fludarabine 25 mg/m2 IV daily for 5 days, administered prior to Amtagvi infusion.

Amtagvi doseSingle IV infusion containing 7.5 x 10^9 to 72 x 10^9 viable autologous tumor-derived T cells supplied in frozen infusion bags.

Revision History

2024-06-15policy_added

Initial policy effective 6/15/2024. New policy created for Amtagvi (lifileucel) defining coverage criteria, dosing, prior authorization and coding for a single-dose autologous T-cell therapy for adults with unresectable or metastatic melanoma previously treated with PD-1 blockade and BRAF-directed therapy if BRAF V600 positive.

2025-05-01annual_reviewLatest

Annual revision performed with no criteria changes (Annual Revision date 5/1/2025).

Policy Summary

PayerCigna

PolicyOncology (Injectable) - Amtagvi

Policy CodePolicy IP0625

Change TypeNew policy (6/15/2024); annual revision (5/1/2025) — no criteria changes

Effective DateJun 15, 2024

Next Review Date

Key ActionPrior Authorization is required for Amtagvi; approval duration is 6 months to allow preparation and administration of one dose.

On This Page

OpenPayer

Oncology (Injectable) - Amtagvi

Coverage Summary

Medical-Necessity Criteria

Coding

Provider Actions

Background & Evidence

Revision History

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics