Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Ipilimumab (Yervoy) may be considered medically necessary in individuals 12 years of age or older for
ANY
of the following indications:
Colorectal Cancer
-
As treatment in combination with nivolumab of microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan;
or
Esophageal Cancer
-
As first line treatment in combination with nivolumab for adult individuals with unresectable advanced or metastatic esophageal squamous cell carcinoma;
or
Hepatocellular Carcinoma
-
As treatment of individuals who have been previously treated with sorafenib, in combination with nivolumab;
or
Malignant Pleural Mesothelioma
-
As first-line treatment in combination with nivolumab for individuals 18 years of age and older with unresectable malignant pleural mesothelioma;
or
Melanoma
-
As treatment for individuals with unresectable or metastatic disease;
or
-
As adjuvant treatment for individuals with cutaneous melanoma with pathologic involvement of regional lymphoma nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy;
or
-
As treatment in combination with nivolumab for individuals with unresectable or metastatic melanoma;
or
Non-Small Cell Lung Cancer (NSCLC)
-
As first-line treatment in combination with nivolumab for individuals 18 years of age and older with metastatic disease expressing PD-L1 (1% or greater) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations;
or
-
Treatment of individuals 18 years of age and older with metastatic or recurrent disease with no EGFR or ALK genomic tumor aberrations as first-line treatment, in combination with nivolumab and two (2) cycles of platinum-doublet chemotherapy;
or
Renal Cell Carcinoma
-
As therapy in combination with nivolumab for the treatment of advanced disease in individuals with intermediate or poor-risk, previously untreated advanced renal cell carcinoma;
or
Compendia Sources
- Ipilimumab (Yervoy) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of ipilimumab (Yervoy) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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