Key Messages
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Canada’s Drug Agency (CDA-AMC) recommends that Opdivo plus Yervoy be reimbursed by public drug plans for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC) if certain conditions are met.
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The pan-Canadian Oncology Drug Review Expert Review Committee (pERC) determined that Opdivo plus Yervoy demonstrates acceptable clinical value versus tyrosine kinase inhibitors (TKIs) (sorafenib and lenvatinib), and immunotherapies (atezolizumab plus bevacizumab, and durvalumab plus tremelimumab) in adults with HCC at an advanced stage when it can no longer be surgically removed (unresectable or advanced). This determination was enough for pERC to recommend that Opdivo plus Yervoy be reimbursed.
Given that Opdivo plus Yervoy is expected to be an alternative to TKIs or currently available immunotherapies, acceptable clinical value refers to at least comparable value versus TKIs and immunotherapies. Evidence from a clinical trial (CheckMate 9DW) showed that treatment with Opdivo plus Yervoy likely results in patients living longer (improved overall survival [OS]) compared with sorafenib and lenvatinib at 24 months in patients with unresectable or advanced HCC. Evidence from an indirect treatment comparison suggested better OS with Opdivo plus Yervoy compared to other immunotherapies (atezolizumab plus bevacizumab, and durvalumab plus tremelimumab) after 6 months in adults with unresectable or advanced HCC.
Opdivo plus Yervoy was considered an alternative immunotherapy option that may offer a clinical benefit for some patients beyond 6 months of treatment. A key limitation of the evidence is the absence of information identifying which patients are at a higher risk of death in the first 6 months of treatment.
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Opdivo plus Yervoy should only be covered for the first-line treatment of adults with unresectable or advanced HCC who have Child-Pugh score class A and good performance status. Opdivo plus Yervoy should not be covered if the patient has been previously treated for unresectable or advanced HCC.
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Opdivo plus Yervoy should be prescribed by and managed under the care of clinicians with expertise in managing unresectable or advanced HCC. Reimbursement should be for a maximum of 2 years of treatment. Reimbursement should be discontinued if the cancer becomes worse or there are unacceptable side effects. The total treatment cost of Opdivo plus Yervoy should not exceed that of treatment with the least costly immunotherapy comparator. Important economic feasibility must be addressed for health systems to be able to adopt Opdivo plus Yervoy due to the magnitude of uncertainty in the budget impact.