Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) 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 pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) may be considered medically necessary in individuals 18 years of age and older for the following:
- As therapy in combination with chemotherapy for EITHER of the following:
- Neoadjuvant treatment of individuals with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer; or
- Adjuvant treatment of individuals with HER2-positive early breast cancer at high risk of recurrence; or
- As therapy in combination with docetaxel for the treatment of individuals with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Compendia Sources
Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for any other indication than 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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