ph-0664
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Opdualag™ (nivolumab/relatlimab-rmbw)

Policy Number: PH-0664

 

Intravenous

 

Last Review Date: 04/04/2022

Date of Origin: 04/04/2022

Dates Reviewed: 04/2022

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.

  1. Length of Authorization ∆ 1

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

  1. 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
  1. 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

  1. 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

Δ Notes:

  • Patients responding to therapy who relapse ≥ 6 months after discontinuation due to duration (i.e., receipt of 24 months of therapy) are eligible to re-initiate PD-directed therapy.
  • 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.
  1. Dosage/Administration 1

Indication

Dose

Cutaneous Melanoma

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

  • Administer 480 mg nivolumab and 160 mg relatlimab (contents of 2 vials) intravenously over 30 minutes every 4 weeks until disease progression or unacceptable toxicity

  1. 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
  1. 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.
  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.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C43.0

Malignant melanoma of lip

C43.10

Malignant melanoma of unspecified eyelid, including canthus

C43.11

Malignant melanoma of right eyelid, including canthus

C43.12

Malignant melanoma of left eyelid, including canthus

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

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

 

 

 

OPDUALAG™ (nivolumab/relatlimab-rmbw) Prior Auth Criteria
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