Last Review Date: 04/04/2022

Date of Origin: 04/04/2022

Dates Reviewed: 04/2022

1. Length of Authorization ^{∆ 1}

Coverage will be provided for six (6) months and may be renewed.

2. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

• Opdualag 240 mg/80 mg in a 20 mL single-dose vial: 2 vials per 28 days

B. Max Units (per dose and over time) [HCPCS Unit]:

• 160 billable units (480 mg nivolumab/160 mg relatlimab) every 28 days

3. Initial Approval Criteria ¹

Coverage is provided for the following conditions:

• Patient is at least 12 years of age; AND

Universal Criteria ^1-3

• Patient weighs at least 40 kg; AND
• Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., cemiplimab, avelumab, pembrolizumab, atezolizumab, durvalumab, dostarlimab, etc.), unless otherwise specified ^∆; AND
• Patient does not have active or untreated brain or leptomeningeal metastases; AND

Cutaneous Melanoma † ^1,2,3

• Will not be combined with other therapies; AND
• Used as first-line therapy for unresectable or metastatic* disease

*Metastatic disease includes stage III unresectable/borderline resectable disease with clinically positive node(s) or clinical satellite/in-transit metastases, as well as unresectable local satellite/in-transit recurrence, unresectable nodal recurrence, and widely disseminated distant metastatic disease.

* If confirmed using an immunotherapy assay-http://www.fda.gov/CompanionDiagnostics

† FDA Approved Indication(s); ‡ Compendia recommended indication(s); Ф Orphan Drug

4. Renewal Criteria ^{∆ 1-3}

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), severe immune-mediated adverse reactions (i.e., pneumonitis, colitis, hepatitis, endocrinopathies, nephritis/renal dysfunction, myocarditis, adverse skin reactions/rash, neurologic toxicities, etc.), etc.; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread

5. Dosage/Administration ^{∆ 1}

6. Billing Code/Availability Information

HCPCS Code:

• J9999 – Not otherwise classified, antineoplastic drug (Discontinue use on 10/01/2022)

• J9298 – Injection, nivolumab and relatlimab-rmbw, 3 mg/1 mg; 1 billable unit = 3 mg nivolumab/1 mg relatlimab (Effective 10/01/2022)

NDC(s):

• Opdualag 240 mg of nivolumab and 80 mg of relatlimab per 20 mL single-dose vial: 00003-7125-xx

7. References

1. Opdualag [package insert]. Princeton, NJ; Bristol-Myers Squibb Company; March 2022. Accessed March 2022.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) nivolumab-relatlimab. National Comprehensive Cancer Network, 2022. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed March 2022.

3. Tawbi HA, Schadendorf D, Lipson EJ; RELATIVITY-047 Investigators, et al. Relatlimab and nivolumab versus nivolumab in untreated advanced melanoma. N Engl J Med. 2022;386:24-34.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A