Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of trastuzumab (Herceptin) and trastuzumab biosimilars (Hercessi, Herzuma, Kanjinti, Ontruzant, Ogivri, Trazimera) may be considered medically necessary when the presence of the HER2-overexpression is confirmed by the following:
HER-2 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 probes, or order a new test with ISH or IHC (if new sample available).
Trastuzumab (Herceptin) and trastuzumab biosimilars (Hercessi, Herzuma, Kanjinti, Ontruzant, Ogivri, Trazimera) may be considered medically necessary for
ANY
of the following indications:
Breast Cancer
- For adjuvant treatment of HER2-overexpressing node positive or node negative (estrogen receptor/progesterone [ER/PR] receptor negative or with one high risk feature) breast cancer in ANY of the following:
-
As part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel;
or
-
As part of a treatment regimen with docetaxel and carboplatin;
or
-
As a single agent following multi-modality anthracycline based therapy;
or
-
For metastatic breast cancer in
ANY
of the following:
-
In combination with paclitaxel for first-line treatment of HER2-ovrexpressing metastatic breast cancer;
or
-
As a single agent for treatment of HER2-overexpressing breast cancer in individuals who have received one or more chemotherapy regimens for metastatic disease;
or
Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- For treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in combination with cisplatin and capecitabine or 5-fluorouracil in individuals who have not received prior treatment for metastatic disease.
Compendia Sources
Trastuzumab (Herceptin) and trastuzumab biosimilars (Hercessi, Herzuma, Kanjinti, Ontruzant, Ogivri, Trazimera) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of trastuzumab (Herceptin) and trastuzumab biosimilars (Hercessi, Herzuma, Kanjinti, Ontruzant, Ogivri, Trazimera) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
Procedure Codes
| J9355 | Q5112 | Q5113 | Q5114 | Q5116 | Q5117 | J9999 |
| Q5146 |
