Opdualag™
Drug - Opdualag™ (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.
Questions?
MHCP Provider Resource Center 651-431-2700 or 800-366-5411