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DrugOpdualag™ (nivolumab and relatlimab-rmbw) [Bristol-Myers Squibb Company]

October 2022

Therapeutic area - Oncology, Injectable

Initial approval criteria

  • Patient is at least 12 years of age AND

Universal Criteria

  • 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

  • Will not be combined with other therapies AND
  • Used as first-line therapy for unresectable or metastatic disease
  • Initial approval is for 6 months

Renewal 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 the initial approval criteria 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 (e.g., 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
  • Renewal approval is for 6 months

* 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

Quantity limits

  • 480 mg nivolumab and 160 mg relatlimab intravenously every 4 weeks

Billing for Opdualag

Opdualag must be billed as a medical claim.


MHCP Provider Resource Center 651-431-2700 or 800-366-5411

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