Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of margetuximab (Margenza) may be considered medically when the presence of the HER2-overexpression is confirmed by the following:
HER2-overexpression must be verified by ANY ONE of the following FDA approved diagnostic tests:
- An immunohistochemical (IHC) assay with a result of 3+ (positive); or
- A positive fluorescence in situ hybridization (FISH) test (ratio greater than 2.0); or
- Single-probe in situ hybridization (ISH) test with average HER2 copy number 6.0 signals/cell or greater; or
- Dual-probe ISH test HER2/CEP17 (chromosome enumeration probe 17) ratio 2.0 or greater; or HER2/CEP17 ratio less than 2.0 AND average HER2 copy number 6.0 signals/cell or greater.
Confirmatory tests should be performed for borderline results as follows:
- If IHC assay has a result of 2+, confirm with ISH test of the same sample or a new test with IHC or ISH (if new sample available); or
- If FISH test has a HER2 gene/chromosome 17 ratio of 1.8-2.0, confirm with FISH re-test; additional cell counting and recalculation of the ratio; or IHC assay; or
- If single-probe ISH assay has an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with dual-probe ISH or with IHC (if same sample), or with a new ISH or IHC (if new sample available); or
- If dual-probe ISH assay has a HER2/CEP17 ratio less than 2.0 and an average HER2 copy number result of 4.0 to less than 6.0 signals/cell, confirm with one of the following: IHC (if same sample), alternative ISH chromosome 17 probe, or order a new test with ISH or IHC (if new sample available).
The use of margetuximab (Margenza) may be considered medically necessary in individuals 18 years of age and older when the following criteria are met:
Breast Cancer
- Diagnosis of metastatic HER2-positive breast cancer; and
- The individual has had two (2) or more prior anti-HER2 regimens in the metastatic setting.
Compendia Sources
Margetuximab (Margenza) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of margetuximab (Margenza) for any other indication listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.
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