WHAT IS THE CADTH REIMBURSEMENT RECOMMENDATION FOR 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. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? 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). WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? 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. WHY DID CADTH MAKE THIS RECOMMENDATION? Evidence from a clinical trial (RELATIVITY-047) demonstrated that treatment with Opdualag when compared with nivolumab monotherapy resulted in added clinical benefit in patients with previously untreated, histologically confirmed, unresectable stage III or stage IV (metastatic) melanoma. Opdualag met some of the identified patient needs, such as an additional treatment option that is effective in terms reducing the risk of cancer growing, spreading, or getting worse (progression-free survival) and has manageable adverse events. CADTH’s assessment of the health economic analysis found that there was insufficient evidence to justify a price premium for Opdualag over nivolumab and ipilimumab combination therapy. The total drug cost of Opdualag therefore should not exceed the total drug cost of nivolumab and ipilimumab. Based on the sponsor’s submitted price and public list prices for the comparators, the 3-year budget impact of Opdualag is estimated to be $34,304,588.

ADDITIONAL INFORMATION

WHAT IS MELANOMA? Melanoma is a cancer that occurs in skin cells that produce melanin. Melanoma that cannot be removed by surgery (unresectable) or that has spread to other parts of the body (metastatic disease) is associated with a low survival rate. UNMET NEEDS IN MELANOMA: Current treatments may be associated with a number of side effects that may lead to treatment interruptions, delays, or discontinuation. There is an unmet medical need for an additional novel immune checkpoint inhibitor combination therapy in metastatic melanoma which can be used regardless of mutation status. The novel therapy should offer increased efficacy in relation to anti–PD-1 monotherapy and should have a favourable safety profile that does not result in additive toxicities as seen with conventional dual immunotherapy combinations. HOW MUCH DOES OPDUALAG COST? Based on the CADTH base case, the budget impact from the introduction of Opdualag is expected to be $4,734,946 in year 1, $12,890,614 in year 2, and $16,679,027 in year 3. The 3-year net budget impact was estimated to be $34,304,588.