Description
Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) is a fixed-dose combination of two monoclonal antibodies, pertuzumab and trastuzumab, that are antagonists of the human epidermal growth factor receptor 2 (HER2). Pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) is administered subcutaneously by a healthcare provider.
Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
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).
Food and Drug Administration (FDA) Indications
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.
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.
National Comprehensive Cancer Network (NCCN) Recommendations
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 a substitute anywhere that the combination of intravenous pertuzumab and intravenous trastuzumab are given as part of systemic therapy.
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.
Procedure Codes
Note: Do not substitute for or with pertuzumab (Perjeta), trastuzumab (Herceptin), trastuzumab biosimilars, ado-trastuzumab emtansine (Kadcyla), or fam-trastuzumab deruxtecan (Enhertu).
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
Diagnosis Codes
C50.011
|
C50.012
|
C50.019
|
C50.021
|
C50.022
|
C50.029
|
C50.111
|
C50.112
|
C50.119
|
C50.121
|
C50.122
|
C50.129
|
C50.211
|
C50.212
|
C50.219
|
C50.221
|
C50.222
|
C50.229
|
C50.311
|
C50.312
|
C50.319
|
C50.321
|
C50.322
|
C50.329
|
C50.411
|
C50.412
|
C50.419
|
C50.421
|
C50.422
|
C50.429
|
C50.511
|
C50.512
|
C50.519
|
C50.521
|
C50.522
|
C50.529
|
C50.611
|
C50.612
|
C50.619
|
C50.621
|
C50.622
|
C50.629
|
C50.811
|
C50.812
|
C50.819
|
C50.821
|
C50.822
|
C50.829
|
C50.911
|
C50.912
|
C50.919
|
C50.921
|
C50.922
|
C50.929
|
C77.0
|
C77.1
|
C77.2
|
C77.3
|
C77.4
|
C77.5
|
C77.8
|
C77.9
|
C78.00
|
C78.01
|
C78.02
|
C78.1
|
C78.2
|
C78.30
|
C78.39
|
C78.7
|
C79.31
|
C79.32
|
C79.51
|
C79.52
|
Z85.3
|
|
|
Professional Statements and Societal Positions Guidelines
Not Applicable
ND Committee Review
Internal Medical Policy Committee 9-21-2020 Adopted policy effective 9-15-2020
Links
References (PDF)
Disclaimer
Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving and the Company reserves the right to review and update medical policy periodically.
