Opdualag™

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

October 2022

Therapeutic area - Oncology, Injectable

Initial approval 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

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

Opdualag must be billed as a medical claim.

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