CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Amtagvi (lifileucel) — Coverage Criteria

Defines accepted indications, exclusions, coding, and evidence standards for authorization of Amtagvi (lifileucel) for members; applies to providers submitting requests to Evolent for Neighborhood Health Plan of Rhode Island lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAmtagvi (lifileucel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent for all requests; continuation requests may be exempt if no disease progression and prior authorization criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1FDA-approved cancer indication

J9999Billing code

72 x 10^9Dose max (viable cells)

6Applicable LOBs

Coverage Criteria for Amtagvi (lifileucel)

Initial therapy — Melanoma

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAmtagvi (lifileucel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization from Evolent for all requests; continuation requests may be exempt if no disease progression and prior authorization criteria are met.

SourceLink

On This Page

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Covered when ALL of the following are met for melanoma:

Indication and prior therapy: Adult member with unresectable or metastatic melanoma previously treated with an immune checkpoint inhibitor; if BRAF V600 mutation positive, previously treated with a BRAF inhibitor with or without a MEK inhibitor.

Supported by FDA indication and guideline text in document.

Evidence support: Use is supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

From policy purpose and references.

Requests for Amtagvi (lifileucel) will be excluded and denied when any of the following are present: disease progression while taking lifileucel; concurrent use with other anticancer therapies; or dosing that exceeds the single-dose limit of 72 x 10^9 viable cells. These conditions are absolute exclusions and will result in non-coverage of the request.

Off-label or investigational uses of Amtagvi (lifileucel) that lack adequate supporting evidence are considered not medically necessary. Adequate evidence is defined by representation of the patient and tumor clinical characteristics in the published literature, appropriate representation of the administered regimen, reporting of clinically meaningful outcomes (for example, as recommended by ASCO: hazard ratio < 0.80 and survival benefit for OS and PFS of at least 3 months), appropriate experimental design for the question addressed, and reliance on full peer‑reviewed publications rather than case reports or abstracts alone. Uses not meeting these standards or not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature will be non‑covered.

Regimen	Indication	Coverage status
One-time autologous lifileucel (Amtagvi) infusion per FDA/label and guideline criteria.	Unresectable or metastatic melanoma in adults previously treated with an immune checkpoint inhibitor; if BRAF V600 mutation positive, prior treatment with a BRAF inhibitor with or without a MEK inhibitor.	Covered with criteria

Coding and Quantity Limits

Billing HCPCS CodesHCPCS

J9999

lifileucel injection

Billing HCPCS CodesHCPCS

J9999

lifileucel injection

Single dose viable cells limit

Single-dose maximum72 x 10^9 viable cells per single dose

ContextDosing exceeding this single dose limit is listed as an exclusion condition and may trigger denial

Location in policyCODING — Single dose viable cells limit

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all medication requests for Amtagvi (lifileucel). Evolent processes prior authorization requests for network ordering providers. Continuation requests may be exempt when the member has not experienced disease progression on the medication, the medication was used within the last year without a lapse of >30 days of active authorization, and no additional medications are being added to the continuation request.

Evolent processes all medication requests for network ordering providers
Continuation exemption: no disease progression; used within last year with ≤30-day lapse; no additional medications added

Step Therapy

Pretreatment Requirements for Melanoma

Amtagvi (lifileucel) for melanoma requires prior systemic treatments before approval. The member must have unresectable or metastatic melanoma and have been previously treated with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab, ipilimumab, atezolizumab). If the tumor is BRAF V600 mutation–positive, prior treatment with a BRAF inhibitor (e.g., dabrafenib, encorafenib, vemurafenib) with or without a MEK inhibitor (e.g., binimetinib, cobimetinib, trametinib) is required.

Prior immune checkpoint inhibitor required (e.g., pembrolizumab, nivolumab, ipilimumab, atezolizumab)
If BRAF V600 mutation positive, prior BRAF inhibitor ± MEK inhibitor required (e.g., dabrafenib, encorafenib, vemurafenib; ± binimetinib, cobimetinib, trametinib)

Documentation Required

Required Supporting Evidence

Use of Amtagvi (lifileucel) must be supported by one of the following sources of evidence: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer‑reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15). Continuation approvals are exempted as specified when criteria are met.

Acceptable evidence: FDA labeling; CMS-approved compendia; NCCN or ASCO guidelines; peer‑reviewed literature meeting CMS criteria
Peer‑reviewed evidence must adequately represent patient and regimen characteristics, clinical outcomes (clinically meaningful per ASCO guidance), and appropriate study design

Denial Risk

Exclusion Conditions That Trigger Denial

The following exclusion conditions will result in denial of Amtagvi (lifileucel) requests.

Disease progression while taking Amtagvi (lifileucel)
Concurrent use with other anticancer therapies
Dosing that exceeds the single-dose limit of 72 × 10^9 viable cells
Investigational or off-label indications lacking sufficient evidence (not supported by CMS compendia or acceptable peer‑reviewed literature). Insufficient evidence considerations include: inadequate representation of the patient/cancer characteristics or the administered regimen in the published evidence; outcomes not clinically meaningful per ASCO standards (e.g., HR ≥ 0.80 or OS/PFS benefit < 3 months); poor experimental design or reliance on uncontrolled case reports/meeting abstracts without full peer‑reviewed publication

Line of Therapy Criteria

Second-line — Melanoma

Prior therapies: Previously treated with an immune checkpoint inhibitor; if BRAF V600 mutation positive, treated with a BRAF inhibitor +/- MEK inhibitor.

Defines prior-line requirements for use.

Biomarker and Mutation Requirements

BRAF V600 — biomarker requirement

Biomarker assessedBRAF V600

If BRAF V600 positiveMember must have received prior treatment with a BRAF inhibitor (with or without a MEK inhibitor)

If BRAF V600 negative or unknownPrior BRAF-targeted therapy is not required; standard prior requirement remains immune checkpoint inhibitor

Definitions and Outcome Thresholds

Clinically meaningful outcomes — ASCO examples

ASCO examples — hazard ratioHazard ratio (HR) < 0.80 qualifies as clinically meaningful

ASCO examples — survival benefitOverall survival (OS) or progression-free survival (PFS) benefit of at least 3 months qualifies as clinically meaningful

Source guidanceASCO recommendations cited in policy references (Ellis LM et al., J Clin Oncol. 2014) and policy exclusion criteria

Background

Lifileucel (Amtagvi) is a one‑time autologous tumor‑infiltrating lymphocyte (TIL) cell therapy indicated for use in advanced melanoma after prior systemic therapies. As a manufactured, patient‑specific cellular product, lifileucel is administered once (single infusion) and carries a defined per‑dose viable cell limit of 72 x 10^9 viable cells per the policy exclusions. Clinical evidence and prescribing information describe lifileucel as a specialized, single‑use adoptive cell therapy intended for patients with unresectable or metastatic disease following progression on prior immune checkpoint inhibitors (and prior BRAF‑targeted therapy when BRAF V600 mutation–positive).