Nivolumab and Relatlimab (Opdualag)

CADTH recommends that Opdualag be reimbursed for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma who have not received prior systemic therapy for unresectable or metastatic melanoma if certain conditions are met. Opdualag should only be covered to treat patients aged 12 years or older who have a histologically confirmed diagnosis of unresectable stage III or stage IV (metastatic) melanoma and have not received prior systemic therapy for advanced melanoma. Patients should be in relatively good health (i.e., have a good performance status, as determined by a specialist). Patients who had prior adjuvant or neoadjuvant anti–programmed death-1 (PD-1) or anti–cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) therapy if the therapy was completed at least 6 months before the date of recurrence are eligible for reimbursement. Opdualag should not be reimbursed in patients with active brain metastases, uveal melanoma, and active autoimmune disease. Opdualag should only be reimbursed if the price of Opdualag is reduced. The feasibility of adoption of Opdualag must also be addressed.