CurrentEmblemHealthPolicy MG.MM.PH.355

Opdualag (nivolumab and relatlimab-rmbw) intravenous infusion

Defines clinical coverage, dosing limits, authorization and renewal criteria for Opdualag for treatment of unresectable or metastatic melanoma for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyOpdualag (nivolumab and relatlimab-rmbw) intravenous infusion

Policy CodePolicy MG.MM.PH.355

Change TypeInitial criteria clarifiedcoding update

Effective Date

Next Review DateMar 4, 2025

Key ActionSubmit clinical evidence demonstrating the member meets the policy criteria to support prior authorization.

SourceLink

POLICY UPDATE CHANGES

Initial Criteria updated to specify prior PD-1/PD-L1 therapy exclusions and to allow use as first-line, subsequent therapy when PD-1 was not previously used, or re-induction after prior anti-PD-1/LAG-3 therapy with disease control and relapse >3 months.

J9999 billing code was removed from the policy.

12 monthsLength of authorization

480/160 mgDose per 4-week infusion

Every 4 wksDosing frequency

≥40 kgWeight requirement

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Coverage Criteria for Opdualag

Initial Therapy — Melanoma

Covered when ALL of the following are met for melanoma:

Melanoma initial coverage criteria

Therapy conditions: i. Used as first-line therapy; OR ii. Patient has not received previous PD-1/PD-L1-directed therapy and is being used as subsequent therapy for disease progression if single-agent anti-PD-1 therapy or combination checkpoint blockade was not previously used; OR iii. Used as re-induction therapy in patients with prior combination anti-PD-1/LAG-3 therapy that resulted in disease control (complete response, partial response, or stable disease) with no residual toxicity, but with disease progression or relapse >3 months after treatment discontinuation
Computed from policy text

Renewal Therapy

Renewal criteria — approvals continued when ALL are met:

Renewal criteria: 1. Member is responding positively to therapy, as determined by the prescriber; AND 2. Member has not experienced unacceptable toxicity from the drug

Prescriber assessment required

Use of Opdualag is limited to patients who meet all policy requirements. The policy therefore excludes use when one or more of the following conditions are not met: the member does not have melanoma or does not have unresectable or metastatic disease; the member is 12 years of age; the member weighs 40 kg

EmblemHealth requires the treating clinician to submit clinical evidence that the member meets the policy criteria. If the requested authorization or post‑payment documentation does not include the necessary clinical information, EmblemHealth will be unable to properly review the request and the service may be considered not medically necessary due to insufficient documentation.

Regimen	Indication	Dose per 4-week infusion	Frequency	Age eligibility	Weight eligibility	Coverage
480 mg nivolumab + 160 mg relatlimab IV
Treatment of unresectable or metastatic melanoma
480 mg nivolumab / 160 mg relatlimab (160 billable units)
Once every 4 weeks (no more frequently than every 4 weeks)
> 12 years
>= 40 kg
Covered with criteria

Allowed Lines of Therapy and Re-induction

Line of Therapy — first-line | subsequent | re-induction

Allowed lines: First-line therapy; OR Subsequent therapy when single-agent anti-PD-1 or combination checkpoint blockade was not previously used; OR Re-induction after prior anti-PD-1/LAG-3 therapy with prior disease control and relapse >3 months

Policy explicitly permits these scenarios including re-induction after prior disease control with relapse >3 months

Biomarker and Re-biopsy Considerations

MSI status / actionable mutation change on re-biopsy

Re-biopsy considerationPatients whose tumors, upon re-biopsy, demonstrate a change in actionable mutation (e.g., MSS initial biopsy; MSI‑H subsequent biopsy) may be eligible to re‑initiate PD‑directed therapy and will be evaluated on a case‑by‑case basis.

MSI status relevanceA change from MSS to MSI‑H on subsequent biopsy is specifically noted as a scenario that may permit re‑initiation of PD‑directed therapy.

Re‑induction eligibilityRe‑induction with anti‑PD‑1/LAG‑3 therapy is allowed for patients with prior combination therapy that produced disease control (CR/PR/SD) with no residual toxicity and disease progression or relapse >3 months after discontinuation.

Evaluation approachPatients with actionable mutation changes on re‑biopsy will be evaluated individually to determine eligibility for PD‑directed therapy re‑initiation.

Applicable Codes

Applicable HCPCS/CPT CodesHCPCSCovered

J9298

Injection, nivolumab and relatlimab-rmbw, 3 mg/1 mg; 1 billable unit 3 mg nivolumab/1 mg relatlimab

Applicable NDC CodesNDCCovered

00003-7125-11

80 mg relatlimab and 240 mg nivolumab 20 mL (single-dose vial)

Applicable ICD-10 DiagnosesICD-10Covered

C43	Malignant melanoma of skin
C21	Malignant neoplasm of anus and anal canal
C51	Malignant neoplasm of vulva
C52	Malignant neoplasm of vagina
C57	Malignant neoplasm of other and unspecified female genital organs
C60	Malignant neoplasm of penis
C63	Malignant neoplasm of other and unspecified male genital organs

Weight

Weight requirementPatient must weigh >= 40 kg.

Age tie-inWeight requirement applies to patients for whom the recommended dose is specified (patients > 12 years and weighing >= 40 kg).

Dosing relevanceThe product dosing (480 mg nivolumab + 160 mg relatlimab IV every 4 weeks) is recommended for patients at or above the 40 kg threshold.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization
Prior authorization and dosing limits
Prior authorization is required for Opdualag. Approvals are issued for 12 months and dosing is limited to 480 mg nivolumab + 160 mg relatlimab administered by IV no more frequently than once every 4 weeks (160 billable units per 28 days).
Length of authorization: 12 months
Dosing limit: 480 mg nivolumab + 160 mg relatlimab IV once every 4 weeks (160 billable units every 28 days)

Step Therapy
Therapy sequencing requirements (first-line, subsequent, re‑induction)
Opdualag may be approved as first-line therapy, as subsequent therapy when the patient has not previously received PD-1/PD-L1–directed therapy (or when single‑agent anti‑PD‑1 or combination checkpoint blockade was not previously used), or as re‑induction after prior anti‑PD‑1/LAG‑3 therapy if prior disease control (CR/PR/SD) occurred and relapse/progression >3 months after discontinuation.
First-line therapy is permitted.

Background on Opdualag and Indication

Opdualag is a fixed‑dose combination product that combines a PD‑1 blocking antibody (nivolumab) with a LAG‑3 blocking antibody (relatlimab) for the treatment of unresectable or metastatic melanoma. The policy applies the manufacturer’s dosing approach and covers administration in patients older than 12 years who weigh at least 40 kg, and it addresses use as first‑line therapy, as subsequent therapy when prior single‑agent anti‑PD‑1 or combination checkpoint blockade was not previously used, and as re‑induction after prior anti‑PD‑1/LAG‑3 therapy when prior disease control was achieved and relapse occurred more than 3 months after discontinuation.

Definitions

Opdualag (nivolumab and relatlimab-rmbw)

Proprietary nameOpdualag (nivolumab and relatlimab-rmbw)

MechanismFixed‑dose combination of a PD‑1 blocking antibody (nivolumab) and a LAG‑3 blocking antibody (relatlimab).

Indication summaryIndicated for the treatment of unresectable or metastatic melanoma; dosing guidance provided for patients >12 years and >=40 kg.

Policy Revision History

2025-03-04criteria_updateLatest

Annual review updated initial melanoma criteria to operationalize approval scenarios: added explicit language allowing first-line use, subsequent therapy when prior PD-1/PD-L1 therapy was not previously used, and re‑induction after prior anti‑PD‑1/LAG‑3 therapy with prior disease control and relapse >3 months.

2024-01-29coding_update

Annual review removed billing code J9999 from the policy.

2023-05-24