CurrentCentenePolicy N/A

Nivolumab and relatlimab-rmbw (Opdualag)

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, excluded indications, coding guidance and documentation expectations for Opdualag for commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyNivolumab and relatlimab-rmbw (Opdualag)

Policy CodePolicy N/A

Change TypeAnnual review (revised/clarified/added coding)

Effective DateSep 1, 2022

Next Review Date

Key ActionProvider must submit chart notes, lab results or other clinical information supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

3Q 2024 annual review: added off-label indication for resectable or limited resectable melanoma per NCCN 2A recommendation; revised weight criteria to apply only to pediatric patients per PI; references reviewed and updated.

3Q 2025 annual review: no significant changes; references reviewed and updated.

Added HCPCS code J9298 for injection, nivolumab and relatlimab-rmbw.

1Covered Indications (FDA)

1Off-label Indications (NCCN 2A allowed)

1Relevant HCPCS codes

Coverage Summary

Coverage stance: covered_with_criteria. Opdualag (nivolumab and relatlimab-rmbw) is the fixed-dose combination of PD-1 and LAG-3 blocking antibodies indicated by the FDA for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Policy aligns coverage with FDA-approved regimens and NCCN recommendations and includes a pediatric weight-based constraint per the prescribing information: >= 40 kg for ages 12 to 18 years. Approval requires meeting the plan's initial or continued therapy criteria and adheres to dosing limits of <= 480 mg nivolumab and 160 mg relatlimab every 4 weeks.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Authorization is required and requests will be evaluated against the policy's initial or continuation criteria. Initial approvals are granted for 6 months; continuation (renewal) approvals are granted for 12 months.

J9298

Documentation Required

Submit supporting documentation

Providers must submit supporting documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.

Documentation Required

Off-label evidence submission

For off-label uses (e.g., resectable or limited resectable melanoma), the prescriber must submit supporting evidence from relevant practice guidelines or peer-reviewed literature to justify the requested regimen or indication.

Billing Rule

Coding guidance informational

HCPCS and other codes in this policy are provided for informational purposes only and do not guarantee coverage. Providers should reference the most up-to-date professional coding guidance when submitting claims.

Key Thresholds

Pediatric weight minimum>= 40 kg for ages 12 to 18 years

Maximum dosing interval dose<= 480 mg nivolumab and 160 mg relatlimab every 4 weeks

Clinical Evidence & References

Evidence references (labels as in the brief):

Key trial: "Relatlimab and nivolumab versus nivolumab in untreated advanced melanoma (NEJM 2022)".

Prescribing information: "Opdualag Prescribing Information, Bristol Myers Squibb, March 2024".

NCCN guidance: "NCCN Melanoma: Cutaneous Version 2.2025".

Background and Definitions

Opdualag is a fixed-dose combination of antibodies targeting PD-1 and LAG-3. The product combines nivolumab and relatlimab-rmbw to block programmed death receptor-1 (PD-1) and lymphocyte activation gene-3 (LAG-3).

Indication summary: FDA-approved for treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The melanoma dosing regimen is a maximum of 480 mg nivolumab with 160 mg relatlimab IV every 4 weeks.

Alignment: Policy coverage is aligned with FDA-approved regimens and NCCN recommendations; off-label resectable or limited resectable melanoma may be considered per NCCN 2A guidance when supported by submitted evidence.

Definitions:

Opdualag: Fixed-dose combination of nivolumab and relatlimab-rmbw (PD-1 and LAG-3 blocking antibodies).

FDA-approved indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.

Revision History

2022-09-09code_added

Initial template change added: HCPCS code J9298 (injection, nivolumab and relatlimab-rmbw) was added to the policy on 09.09.22.

2024-05-23policy_revised

3Q 2024 annual review (P&T Approval Date 08.24): added off-label indication for resectable or limited resectable melanoma per NCCN 2A recommendation; revised weight criteria to apply only to pediatric patients per prescribing information; references reviewed and updated.

2025-05-13policy_clarifiedLatest

3Q 2025 annual review (P&T Approval Date 08.25): no significant changes; references reviewed and updated.