J9355, Injection, trastuzumab, excludes biosimilar, 10 mg
HCPCS/CPT
Prior Authorization
Prior Auth Required
Code explicitly requires prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Precertification / Statement of Medical Necessity (SMN) forms required for precertification (contact: call (866) 752-7021 or fax (888) 267-3277; see Specialty Pharmacy Precertification forms).
- Documentation of tumor HER2 status using an FDA-approved companion diagnostic (e.g., IHC and/or FISH) performed by laboratories with demonstrated proficiency. The policy specifies using FDA-approved tests for HER2 assessment.
- For colorectal cancer indication: documentation that tumor is HER2-amplified and RAS and BRAF wild-type, and documentation that therapy will be given in combination with pertuzumab or lapatinib and that patient meets one of the specified scenarios (not appropriate for intensive therapy OR subsequent therapy for progression).
- Evidence of prior therapies and clinical context where relevant (e.g., prior systemic therapy, progression status, suitability for intensive therapy) to support the chosen indication.
Key Coverage Criteria
- Coverage of injectable oncology medications is based on NCCN Compendium Categories of Evidence and Consensus (1, 2A, 2B = proven/medically necessary; 3 = unproven/not medically necessary); if NCCN is unavailable, base decisions on FDA labeling.
- C18.0 - C18.9 Malignant neoplasm of colon [unresectable, advanced, or metastatic]
- C20 Malignant neoplasm of rectum
- Subcutaneous formulation (trastuzumab and hyaluronidase-oysk; Herceptin Hylecta) as an approved formulation of trastuzumab for the same HER2-positive breast cancer indications (inferred from prescribing information and FDA approval notice).
- Neoadjuvant treatment of HER2-positive breast cancer as part of a complete treatment regimen (trastuzumab or biosimilars).
- Adjuvant treatment of HER2-positive breast cancer (trastuzumab or biosimilars).
16 Active Policies
UHC-POL-oncology-medication-clinical-coverage-policy, Oncology Medication Clinical Coverage
AETNA-CPB-0313, Trastuzumab Products
BCBSIL-RX502.061, Oncology Medications
BCBSMT-RX502.061, Oncology Medications
BCBSNM-RX502.061, Oncology Medications
Related Codes
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