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Opdualag™ (nivolumab/relatlimab-rmbw) (Intravenous)

Policy Number: VP-0664

Last Review Date: 09/05/2023

Date of Origin: 04/04/2022

Dates Reviewed: 04/2022, 11/2022, 05/2023, 09/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization 1

Coverage will be provided for 6 months and may be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Opdualag 240 mg/80 mg in a 20 mL single-dose vial: 2 vials per 28 days
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 160 billable units (480 mg nivolumab/160 mg relatlimab) every 28 days

III. 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, retifanlimab, nivolumab, etc.), unless otherwise specified ; AND

Cutaneous Melanoma † ‡ Ф 1-4

  • Patient has unresectable or metastatic* disease; AND
    •  
    • Used as first-line therapy; OR
    • Used as subsequent therapy for disease progression if single-agent anti-PD-1 therapy or combination checkpoint blockade was not previously used; OR
    • Used as re-induction therapy in patients with prior combination anti-PD-1/LAG-3 therapy that resulted in disease control (i.e., complete response, partial response, or stable disease) with no residual toxicity, but with disease progression or relapse >3 months after treatment discontinuation

*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.

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria 1-4

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

Δ Notes:

  • Patients who complete adjuvant therapy and progress ≥ 6 months after discontinuation are eligible to re-initiate PD-directed therapy for metastatic disease.
  • Patients 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.

V. Dosage/Administration 1

Indication

Dose

Cutaneous Melanoma

Adult and pediatric patients ≥12 years of age who weigh at least 40 kg:

  • Administer 480 mg nivolumab and 160 mg relatlimab (contents of 2 vials) intravenously every 4 weeks until disease progression or unacceptable toxicity

VI. Billing Code/Availability Information

HCPCS Code:

  • J9298 – Injection, nivolumab and relatlimab-rmbw, 3 mg/1 mg; 1 billable unit = 3 mg nivolumab/1 mg relatlimab-rmbw

NDC:

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

VII. References

  1. Opdualag [package insert]. Princeton, NJ; Bristol-Myers Squibb Company; March 2022. Accessed July 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) nivolumab-relatlimab. National Comprehensive Cancer Network, 2023. 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 August 2023.
  1. 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.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Melanoma: Cutaneous. Version 2.2023. National Comprehensive Cancer Network, 2023. 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 July 2023.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C43.0

Malignant melanoma of lip

C43.111

Malignant melanoma of right upper eyelid, including canthus

C43.112

Malignant melanoma of right lower eyelid, including canthus

C43.121

Malignant melanoma of left upper eyelid, including canthus

C43.122

Malignant melanoma of left lower eyelid, including canthus

C43.20

Malignant melanoma of unspecified ear and external auricular canal

C43.21

Malignant melanoma of right ear and external auricular canal

C43.22

Malignant melanoma of left ear and external auricular canal

C43.30

Malignant melanoma of unspecified part of face

C43.31

Malignant melanoma of nose

C43.39

Malignant melanoma of other parts of face

C43.4

Malignant melanoma of scalp and neck

C43.51

Malignant melanoma of anal skin

C43.52

Malignant melanoma of skin of breast

C43.59

Malignant melanoma of other part of trunk

C43.60

Malignant melanoma of unspecified upper limb, including shoulder

C43.61

Malignant melanoma of right upper limb, including shoulder

C43.62

Malignant melanoma of left upper limb, including shoulder

C43.70

Malignant melanoma of unspecified lower limb, including hip

C43.71

Malignant melanoma of right lower limb, including hip

C43.72

Malignant melanoma of left lower limb, including hip

C43.8

Malignant melanoma of overlapping sites of skin

C43.9

Malignant melanoma of skin, unspecified

Z85.820

Personal history of malignant melanoma of skin

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC