Trastuzumab products (intravenous) — Clinical coverage and authorization criteria
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Clinical coverage and authorization guidance for trastuzumab and its biosimilars for HER2-positive malignancies for Quartz members; includes FDA-approved and supported off-label uses and dosing summaries.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
Breast Cancer (FDA-approved)
Covered when ALL of the following are met for breast cancer (FDA-approved indications):
Gastric/Esophageal/GE-junction Cancer (FDA-approved)
Covered when ALL of the following are met for gastric/esophageal/GE-junction cancer (FDA-approved):
Colon/Rectal Cancer (supportive evidence)
Covered when ALL of the following are met for colon or rectal cancer (supportive evidence):
Dosing: various regimens including 8 mg/kg IV load then 6 mg/kg IV q3w or 4 mg/kg IV load then 2 mg/kg IV weekly (per source).
Biliary Tract Cancer (supportive evidence)
Covered when ALL of the following are met for biliary tract cancer (supportive evidence):
Dosing: 8 mg/kg IV load followed by 6 mg/kg IV not more frequently than once every 3 weeks (per source).
Endometrial Carcinoma (supportive evidence)
Covered when ALL of the following are met for endometrial carcinoma (supportive evidence):
Dosing: 8 mg/kg IV load followed by 6 mg/kg IV q3w (per source).
Salivary Gland Tumor (supportive evidence)
Covered when ALL of the following are met for salivary gland tumors (supportive evidence):
Dosing: 8 mg/kg IV load followed by 6 mg/kg IV q3w (per source).
Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available.
Circumstances not listed in the Recommended Authorization Criteria are not recommended for approval. Requests outside the specified criteria should be expected to be denied unless and until the policy is amended based on new evidence.
Provider Requirements and Authorization Notes
Prior authorization required for most trastuzumab products
Most trastuzumab products require prior authorization with Quartz; Kanjinti and Trazimera are available without prior authorization.
Authorization requires meeting Recommended Authorization Criteria
Authorization is recommended only when the request meets the policy's Recommended Authorization Criteria; requests outside those criteria are not recommended for approval.
Biliary tract cancer: required sequencing and combination
For biliary tract cancer, trastuzumab is supported only when used in combination with pertuzumab (Perjeta) or tucatinib (Tukysa) after the patient has tried one systemic regimen.
- Medication will be used in combination with Perjeta (pertuzumab) or Tukysa (tucatinib).
- Patient must have tried one systemic regimen prior to use.
Required diagnostic test and specialist prescriber
Selection for therapy must be based on an FDA‑approved companion diagnostic specific for breast or gastric cancer, and the medication should be prescribed by or in consultation with an oncologist.
- Tests are specific for breast cancer or gastric cancer.
- Medication prescribed by or in consultation with an oncologist is required.
Supporting references for clinical context
Product prescribing information (Herceptin intravenous infusion) and NCCN guideline versions are cited to support clinical review and authority for indications.
- Herceptin intravenous infusion prescribing information (Genentech; February 2021).
- NCCN Breast Cancer Clinical Practice Guidelines in Oncology (version 4.2024).
Non‑listed indications are not recommended for approval
Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.
Denial risk for non‑listed indications
Requests for indications or uses outside the Recommended Authorization Criteria carry a denial risk because coverage is not recommended for circumstances not listed in the criteria.
Clinical Background
Trastuzumab is a monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER2) and is indicated for HER2-overexpressing breast cancer in adjuvant and metastatic settings and for metastatic gastric or gastroesophageal junction adenocarcinoma in combination with chemotherapy. Biosimilar trastuzumab products share the FDA-approved indications of the originator. Clinical guidelines (NCCN) also support trastuzumab use across multiple HER2-driven tumor types including select colorectal, biliary tract, endometrial (uterine serous), and salivary gland tumors where supporting evidence exists.
Terms and References
Indication by Line of Therapy
first-line
This reflects the line-of-therapy requirement in the gastric/GEJ FDA-approved criteria.
salvage
Per source, patient must have tried one systemic regimen prior to use.
Diagnostic Test Requirements
Dosing and Administration
| Indication | Dosing regimen |
|---|---|
| Adjuvant breast cancer (total 52 weeks) | Initial 4 mg/kg IV, then 2 mg/kg IV weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel/carboplatin); one week after last weekly dose give 6 mg/kg IV every 3 weeks to complete 52 weeks. Alternative: initial 8 mg/kg IV then 6 mg/kg IV every 3 weeks for a total of 52 weeks. Extending beyond 1 year not recommended. |
| Metastatic breast cancer | Initial 4 mg/kg IV followed by 2 mg/kg IV weekly (trastuzumab alone or with paclitaxel) until disease progression. |
| Metastatic or locally advanced gastric/esophageal/GE‑junction cancer (first‑line, with chemotherapy) | Initial 8 mg/kg IV followed by 6 mg/kg IV every 3 weeks until progression. Guidelines also list alternative schedules (e.g., 6 mg/kg IV Day 1 then 4 mg/kg IV every 14 days) for first‑ or second‑line therapy in combination with chemotherapy. |
| Alternate trastuzumab regimens (other tumor types / combinations) | Other approved/used schedules include: 4 mg/kg IV then 2 mg/kg IV weekly (not more frequently than once weekly); 8 mg/kg IV then 6 mg/kg IV every 3 weeks (not more frequently than once every 3 weeks); and 6 mg/kg IV then 4 mg/kg IV every 2 weeks. Alternate dosing assessed case‑by‑case. |
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