Overview

This document addresses the use of Opdualag. Opdualag is a combination of a programmed death receptor-1 (PD-1) blocking antibody and a lymphocyte activation gene-3 (LAG-3) blocking antibody which is FDA approved for the treatment of adult and pediatric individuals 12 years of age or older with unresectable or metastatic melanoma.

Definitions and Measures

• Adjuvant therapy: Treatment given after the primary treatment to increase the chances of a cure; may include chemotherapy, radiation, hormone or biological therapy.
• BRAF: The oncogene which directions production of a protein in the regulating MAP kinase/ERKs signaling pathway, which affects cell division, differentiation, and secretion.
• Disease Progression: Cancer that continues to grow or spread.
• ECOG or Eastern Cooperative Oncology Group Performance Status: A scale and criteria used by doctors and researchers to assess how an individual’s disease is progressing, assess how the disease affects the daily living abilities of the individual, and determine appropriate treatment and prognosis. This scale may also be referred to as the WHO (World Health Organization) or Zubrod score which is based on the following scale:
  1. Fully active, able to carry on all pre-disease performance without restriction
  2. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, for example, light house work, office work
  3. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
  4. Capable of only limited self care, confined to bed or chair more than 50% of waking hours
  5. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
  6. Dead
• Immune checkpoint inhibitor: A type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. When these proteins are blocked, the “brakes” on the immune system are released and T cells are able to kill cancer cells better. Examples of checkpoint proteins found on T cells or cancer cells include programmed death (PD)-1, PD-ligand 1 (PD-L1), and cytotoxic T-lymphocyte–associated antigen (CTLA)-4/B7-1/B7-2 (NCI, 2018).
• Kinase inhibitor: Type of drug which works by blocking several enzymes that promote cell growth, which has been found to be an effective approach to treat a variety of cancers.
• Melanoma: A type of cancer that begins in the melanocytes. Melanoma is also referred to as malignant melanoma and cutaneous melanoma.
• Metastasis: The spread of cancer from one part of the body to another; a metastatic tumor contains cells that are like those in the original (primary) tumor and have spread.
• Neoadjuvant therapy: Treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery, is given. Examples of neoadjuvant therapy include chemotherapy, radiation therapy, and hormone therapy. It is a type of induction therapy.
• Primary refractory disease: Cancer that does not respond at the beginning of treatment; may also be called resistant disease.
• Progressive Disease (PD): Cancer that is growing, spreading, or getting worse.
• Refractory Disease: Illness or disease that does not respond to treatment.
• Stable disease: Cancer that is not decreasing or increasing in extent or severity.

Clinical Criteria

When a drug is being reviewed for coverage under a member's medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Opdualag (nivolumab and relatlimab-rmbw)

Requests for Opdualag may be approved if the following criteria are met:

1. Individual is 12 years of age or older and weighing at least 40 kg (Label; Tawbi HA et.al. 2022, NCCN 1);AND
2. Individual has a diagnosis of unresectable or metastatic (Stage III or IV) melanoma; AND
3. Individual has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 or a Lansky performance score ">≥80% for minors (12 to 17 years of age).

Requests for Opdualag may not be approved for the following criteria:

1. If individual had uveal melanoma; OR
2. If individual has active brain metastases or leptomeningeal metastases; OR
3. When the above criteria are not met, and for all other indications.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS

• J9298 Injection, nivolumab and relatlimab-rmbw, 3 mg/1 mg [Opdualag]

ICD-10 Diagnosis

• C43.0 Malignant melanoma of lip
• C43.10-C43.12 Malignant melanoma of 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-C43.22 Malignant melanoma of 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-C43.62 Malignant melanoma of unspecified upper limb, including shoulder
• C43.70-C43.72 Malignant melanoma of lower limb, including hip
• C43.8 Malignant melanoma of overlapping sites of skin
• C43.9 Malignant melanoma of skin, unspecified

Document History

Revised: 08/18/2023