CurrentCareSourcePolicy N/A

Trastuzumab (Herceptin and biosimilars) utilization management

Policy governing prior authorization and medical benefit coverage criteria for intravenous trastuzumab products (Herceptin and listed biosimilars) for oncology indications; affects prescribers and payers for CareSource members in North Carolina.

Policy Summary

PayerCareSource

PolicyTrastuzumab (Herceptin and biosimilars) utilization management

Policy CodePolicy N/A

Change TypeMaterial and non-material additions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document HER2-positive status and oncologist involvement for approval.

SourceLink

POLICY UPDATE CHANGES

Added Tukysa (tucatinib tablets) as one of the agents that can be used in combination with trastuzumab for colon or rectal cancer.

Added Hercessi (trastuzumab-strf) biosimilar to the policy.

8+trastuzumab products listed (originator + biosimilars)

52wadjuvant breast cancer duration

1yauthorization duration (most)

NCCN v2024guidelines cited

Recommended Authorization Criteria

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FDA-Approved Indications — Breast Cancer

Coverage of trastuzumab products is recommended when ALL of the following are met for the specified FDA-approved breast cancer indications:

Breast cancer (adjuvant or recurrent/metastatic): A) Patient is >= 18 years of age; AND B) Patient has human epidermal growth factor receptor 2 (HER2)-positive disease; AND C) For neoadjuvant/adjuvant use: trastuzumab is approved for a total of 1 year (52 weeks); OR for recurrent/metastatic disease: approve for 1 year; AND D) The medication is prescribed by or in consultation with an oncologist;

Dosing (select ONE): A) 4 mg/kg IV loading dose followed by 2 mg/kg IV weekly; OR B) 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks; OR C) Alternative schedule per product labeling (as described in the policy).

FDA-Approved Indications — Gastric/Esophageal

Coverage for gastric, esophageal, or gastroesophageal (GE) junction adenocarcinoma is recommended when ALL of the following are met:

Gastric/Esophageal/GE junction adenocarcinoma (locally advanced or metastatic): A) Patient is >= 18 years of age; AND B) Patient has locally advanced or metastatic disease; AND C) Patient has HER2-positive disease; AND D) Trastuzumab will be used as first-line therapy in combination with chemotherapy (examples: cisplatin, oxaliplatin, capecitabine, 5‑fluorouracil); AND E) The medication is prescribed by or in consultation with an oncologist;

Dosing (select ONE): A) 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks; OR B) Other approved dosing per product labeling (as applicable).

Other Uses with Supportive Evidence

Other uses with supportive evidence are covered when ALL of the specified criteria for each tumor type are met:

Biliary tract cancer: A) Patient is >= 18 years of age; AND B) Patient has HER2-positive unresectable or metastatic disease; AND C) Trastuzumab will be used in combination with pertuzumab (Perjeta) or tucatinib (Tukysa); AND D) Patient has tried at least one prior systemic regimen (examples: gemcitabine + cisplatin; 5‑FU + oxaliplatin; capecitabine + oxaliplatin; gemcitabine + oxaliplatin); AND E) The medication is prescribed by or in consultation with an oncologist;

Colon or rectal cancer: A) Patient is >= 18 years of age; AND B) Patient has advanced or metastatic disease; AND C) Patient has HER2-positive disease; AND D) Trastuzumab will be used in combination with pertuzumab, lapatinib, or tucatinib; AND E) The medication is prescribed by or in consultation with an oncologist;

Endometrial carcinoma (uterine serous): A) Patient is >= 18 years of age; AND B) Patient has HER2-positive disease; AND C) Patient has advanced or recurrent uterine serous carcinoma; AND D) Trastuzumab will be used in combination with chemotherapy; AND E) The medication is prescribed by or in consultation with an oncologist;

Coverage of trastuzumab products (Herceptin and listed biosimilars) is recommended only when the patient and clinical scenario meet the specific criteria described in the Recommended Authorization Criteria for each indication (see FDA‑approved and supportive‑evidence sections). Coverage is not recommended for circumstances that are not listed in those criteria. Prior authorization is recommended for medical benefit coverage; approvals are provided for the durations noted in the criteria (commonly 1 year when specified and when dosing and other requirements are met).

Update note: This policy includes recent revisions to the list of trastuzumab biosimilars and added language reflecting newer recommended combination partners (e.g., tucatinib) for certain tumor types; the Recommended Authorization Criteria will be updated as new published data become available.

Requests for trastuzumab for indications that are not included in the Recommended Authorization Criteria are considered not recommended for approval and may be denied. Providers seeking coverage for off‑label or unlisted uses should include supportive clinical evidence and understand that the policy will be updated only as new published data are available.

Regimen	Tumor type / Setting	Notes
Trastuzumab + paclitaxel
Breast — preoperative / adjuvant; also used in metastatic disease
NCCN lists trastuzumab plus paclitaxel as a preferred preoperative/adjuvant regimen (category 2A); also used in metastatic disease in combination with other agents

Product Listing, Codes, and Treatment Duration

Referenced products (no procedure codes provided)mixed

Herceptin (trastuzumab) and listed biosimilars: Hercessi, Kanjinti, Herzuma, Ogivri, Ontruzant, Trazimera

Adjuvant treatment duration (coding/thresholds)

Adjuvant treatment duration52 weeks (total duration of adjuvant trastuzumab therapy)

Initial/maintenance dosing (context)Initial 4 mg/kg IV then 2 mg/kg weekly for 12–18 weeks with chemotherapy, then 6 mg/kg every 3 weeks to complete 52 weeks

Extension beyond 1 yearExtending adjuvant treatment beyond 1 year is not recommended

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for medical benefit coverage of trastuzumab products. Approvals are granted only when the patient meets the Recommended Authorization Criteria and documented dosing in the policy. Typical approval durations: 1 year for most FDA-approved and supported indications; extended or alternate durations may be considered case-by-case by a clinician (Medical Director or Pharmacist). Because of required specialized evaluation and monitoring, trastuzumab must be prescribed by or in consultation with a physician who specializes in the treated condition (e.g., an oncologist).

Approval duration: generally 1 year unless otherwise specified
Prescriber requirement: must be prescribed by or in consultation with an oncologist

Step Therapy

Prior Systemic Therapy Required (Biliary Tract)

For biliary tract cancer, prior authorization will require documentation that the patient has previously tried at least one systemic chemotherapy regimen (examples: gemcitabine + cisplatin; 5‑fluorouracil + oxaliplatin; capecitabine + oxaliplatin; gemcitabine + oxaliplatin). Approval is contingent on HER2‑positive status, unresectable or metastatic disease, use in combination with pertuzumab or tucatinib, age ≥ 18, and oncologist involvement.

Required prior systemic therapy: at least one prior systemic regimen documented
Examples of systemic regimens: gemcitabine/cisplatin; 5‑fluorouracil/oxaliplatin; capecitabine/oxaliplatin; gemcitabine/oxaliplatin

Documentation Required

Prescriber and Clinical Documentation Required

Trastuzumab must be prescribed by or in consultation with an oncologist. Prior authorization requests should include documentation of: patient age, HER2‑positive disease status, disease stage (e.g., unresectable or metastatic), prior systemic therapy where required (biliary tract), planned combination agents (if applicable), and the dosing regimen. Lack of adequate clinical documentation may result in denial.

Document: patient age (≥ 18 years)
Document: HER2‑positive disease
Document: prior systemic regimen for biliary tract cancer when applicable
Document: prescribing oncologist or oncology consultation and planned combination therapy

Denial Risk

Non‑Listed Indications Not Recommended for Approval

Requests for trastuzumab for indications not listed in the Recommended Authorization Criteria are not recommended for approval and may be denied. The criteria will be updated as new published data become available; submitters should reference current policy criteria.

Non‑listed indications: likely denial
Policy updates: criteria may change with new evidence

Therapy Line Definitions and Application

first-line | second-line | salvage

Line-of-therapy applicability (top-level summary for indications and combinations):

Line of therapy: Breast: adjuvant/neoadjuvant (total duration 1 year) or recurrent/metastatic therapy as indicated; Gastric: first-line therapy in combination with chemotherapy; Biliary tract: used in combination with pertuzumab or tucatinib after at least one prior systemic regimen; Colon/rectal: used in combination with other HER2-targeted agents for advanced/metastatic disease (typically later-line as per guidelines);

HER2 Testing and Biomarker Criteria

HER2 biomarker requirement (inv-15)

HER2 positivity requirementHER2-positive as determined by an FDA-approved companion diagnostic specific for breast or gastric cancer

Tumor types referencedRequired for selection for therapy in breast cancer and gastric/GE-junction adenocarcinoma; biosimilars share same indications

Prescriber requirementMedication must be prescribed by or in consultation with an oncologist when used for FDA-approved indications

Example Regimens and Combinations

Regimen	Tumor type / Setting	Notes
Trastuzumab + lapatinib
Colon / rectal — advanced/metastatic
NCCN lists combinations with lapatinib for HER2‑amplified colon/rectal cancer (used in combination with other HER2‑targeted agents)

Key Terms

human epidermal growth factor receptor 2 (HER2)-positive — definition

DefinitionHuman epidermal growth factor receptor 2 (HER2)-positive: disease expressing/amplifying HER2 as identified by an FDA-approved companion diagnostic

Testing specificityCompanion diagnostics for trastuzumab are specific for breast cancer or gastric cancer testing

Clinical implicationHER2-positive status is required for selecting patients for trastuzumab or listed biosimilars across indicated tumor types

Clinical Background

Trastuzumab and its biosimilars are monoclonal antibodies that target the HER2 (human epidermal growth factor receptor 2) protein expressed on the surface of tumor cells. These agents bind to HER2 and inhibit downstream signaling pathways that drive tumor cell growth and survival, and they can mediate immune‑dependent cytotoxicity. Trastuzumab is indicated for HER2‑positive breast and gastric/gastroesophageal cancers and is used, per the criteria in this policy, in select other HER2‑positive tumors in combination with other agents based on supportive evidence.

Selection of trastuzumab therapy requires confirmation of HER2‑positive status using an FDA‑approved companion diagnostic specific for the tumor type, and dosing/duration differ by adjuvant versus metastatic settings (for example, adjuvant breast therapy is given for a total of 52 weeks as noted in dosing guidance).