Medical Drug Criteria (MDC)

Policy Num:       P1.001.014
Policy Name:     OPDUALAG™ (nivolumab and relatlimab-rmbw)
Policy ID:          [P1.001.014] [Ac/L/ M+/ P+ ][0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

Related MDC: NONE

OPDUALAG™ (nivolumab and relatlimab-rmbw)

Summary

Nivolumab;relatlimab-rmbw (Opdualag) has been approved for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma. Opdualag is a combiation of nivolumab, a monoclonal antibody that enhances the antitumor immune response by binding to the programmed death receptor-1 (PD-1) and blocking its interaction with ligand 1 and 2 (PD-L1 and PD-L2), and relatlimab, binds to the lymphocyte activation gene-3 (LAG-3) receptor which results in promoting T cell proliferation and cytokine secretion. The combined agents result in inhibition of tumor growth.

Policy Statements

Opdualag may be considered medically necessary in patients 12 years of age or older at least 40 kg for the treatment of adult and pediatric patients with unresectable or metastatic melanoma. 

Policy Guidelines

Coverage eligibility for Nivolumab;relatlimab-rmbw (Opdualag) will be considered when the following criteria are met:

•    Authorization of 12 months may be granted for treatment with unresectable or metastatic melanoma who weigh at least 40 kg

DOSAGE/ADMINISTRATION

The recommended dose of Nivolumab;relatlimab-rmbw (Opdualag) is 480 mg nivolumab and 160 mg relatlimab administered every 4 weeks until disease progression or unacceptable toxicity occurs 

REQUIRED MEDICAL INFORMATION

Initial Therapy

Initiation of treatment with nivolumab;relatlimab-rmbw (Opdualag) meets the definition of medical necessity when used to treat ONE of the following: 

A. Unresectable or metastatic melanoma when ALL of the following are met: 

1. Nivolumab;relatlimab-rmbw will be used for ONE of the following: 

a. First-line systemic therapy 

b. Second-line or subsequent therapy for disease progression and the member has not previously received a checkpoint inhibitor (with exception of the adjuvant or neoadjuvant setting) 

c. Reinduction therapy and BOTH of the following: 

i. Members disease relapsed or progressed greater than 3 months after initial clinical response or stable disease with previous nivolumab treatment

ii. Member does not have any remaining toxicity from previous nivolumab-relatlimab treatment

2. Nivolumab;relatlimab-rmbw (Opdualag) will be used as a single agent

3. The dose does not exceed 480 mg nivolumab and 160 mg relatlimab every 4 weeks

Renewal Approval Criteria 

a)    The patient is currently receiving Nivolumab;relatlimab-rmbw and continues to meet initial criteria; AND  

b)    The member’s disease has not progressed while receiving treatment with nivolumab;relatlimab-rmbw (Opdualag)

c)    Nivolumab;relatlimab-rmbw (Opdualag) will be used as a single agent
 

EXCLUSION CRITERIA

NONE

BENEFIT APPLICATION

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage

OTHER CRITERIA

NONE

Population Reference No. 1 Policy Statement

References

1.    Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2023 [cited 2023 Mar 22]. Available from: http://www.clinicalpharmacology.com/. 
2.    DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2023 Mar 22].
3.    National Cancer Institute. Common Terminology Criteria for Adverse Events. Available at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm. Accessed 04/28/22. 
4.    National Comprehensive Cancer Network®. NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Cutaneous melanoma, v2.2023. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed 03/22/23. 
5.    NCCN Drugs & Biologics Compendium [Internet]. Fort Washington (PA): National Comprehensive Cancer Network;2023. Available from: http://www.nccn.org/professionals/drug_compendium/content/contents.asp/. Accessed 03/22/23.
6.    Opdualag (nivolumab;relatlimab-rmbw) injection [package insert]. Bristol-Myers Squibb Company. Princeton, NJ. March 2024.

7. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2023 [cited 2023 Mar 22]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/

Codes

Applicable Modifiers

N/A

Policy History