CurrentAnthemPolicy CC-0166

Trastuzumab agents (Herceptin and biosimilars) — Clinical prior authorization and step therapy

Clinical prior authorization and step therapy criteria for trastuzumab (Herceptin), Herceptin Hylecta, and specified trastuzumab biosimilars for medical benefit use across Anthem lines of business.

Policy Summary

PayerAnthem

PolicyTrastuzumab agents (Herceptin and biosimilars) — Clinical prior authorization and step therapy

Policy CodePolicy CC-0166

Change TypeStep therapy updatesbiosimilar added (Hercessi)

Effective DateMar 1, 2026

Next Review DateMay 16, 2025

Key ActionObtain prior authorization and document trial and intolerance to a preferred trastuzumab agent or evidence the member is stabilized on the requested non-preferred agent.

SourceLink

POLICY UPDATE CHANGES

Step therapy table updates.

Added biosimilar Hercessi to prior authorization and step therapy criteria.

Updated description for HCPCS J9355.

8+agents listed

J9355,J9356,Q5112–Q5117,Q5146HCPCS codes

All DiagnosesICD-10

Boxed warningsafety

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Trastuzumab Agents

Covered agents

Requests may be approved when the clinical review criteria are met for the following agents:

Herceptin (trastuzumab) may be approved.

Reference product included among covered agents.

Biosimilars: Trastuzumab biosimilars may be approved: Ogivri (trastuzumab-dkst); Herzuma (trastuzumab-pkrb); Ontruzant (trastuzumab-dttb); Trazimera (trastuzumab-qyyp); Hercessi (trastuzumab-strf); Kanjinti (trastuzumab-anns).

Biosimilar approvals are subject to the clinical criteria and applicable prior authorization.

Step therapy (non-preferred agents)

Non-preferred trastuzumab agent approval requires meeting one of the following:

Step therapy exceptions: I. Individual has had a trial and intolerance to one preferred trastuzumab agent.

Preferred agent lists and 'new start' definitions vary by line of business and effective date; see policy listings by benefit type.

Stabilization exception: II. Individual is currently stabilized on the requested non-preferred trastuzumab agent.

Stabilization on the non-preferred agent is an exception to step therapy requirements.

Inclusion or exclusion of a procedure, diagnosis, or device code(s) in this document does not constitute or imply member coverage or provider reimbursement. Coverage determinations are governed by the member's contract benefits in effect at the time of service; providers should refer to the member's contract to determine coverage or non‑coverage for an individual member.

Coding (HCPCS / ICD-10)

HCPCSHCPCS

J9355	Injection, trastuzumab, excludes biosimilar, 10 mg [Herceptin].
J9356	Injection, trastuzumab, 10 mg and hyaluronidase-oysk (Herceptin Hylecta).
Q5112	Injection, trastuzumab-dttb, biosimilar, (Ontruzant), 10 mg.
Q5113	Injection, trastuzumab-pkrb, biosimilar, (Herzuma), 10 mg.
Q5114	Injection, Trastuzumab-dkst, biosimilar, (Ogivri), 10 mg.
Q5116	Injection, trastuzumab-qyyp, biosimilar, (Trazimera), 10 mg.
Q5117	Injection, trastuzumab-anns, biosimilar, (Kanjinti), 10 mg.
Q5146	Injection, trastuzumab-strf (Hercessi), biosimilar, 10 mg.

ICD-10-CMICD-10

All Diagnoses

ICD-10-CM: All diagnoses

Provider Actions and Requirements

Prior Authorization

Prior Authorization May Be Required

Prior authorization (PA) may be required for Herceptin (trastuzumab) and listed trastuzumab biosimilars. Submit a PA when requesting coverage for Herceptin, Herceptin Hylecta, or any of the following biosimilars: Ogivri (trastuzumab-dkst), Herzuma (trastuzumab-pkrb), Ontruzant (trastuzumab-dttb), Trazimera (trastuzumab-qyyp), Hercessi (trastuzumab-strf), Kanjinti (trastuzumab-anns). PA is used to confirm medical necessity and preferred-agent/step-therapy status prior to approval.

Affected agents: Herceptin (trastuzumab); Herceptin Hylecta (trastuzumab; hyaluronidase-oysk); Ogivri; Herzuma; Ontruzant; Trazimera; Hercessi; Kanjinti.
PA verifies medical necessity and adherence to step therapy / preferred-agent rules.
Submit supporting clinical documentation with the PA (see documentation callout).

Step Therapy

Step Therapy Requirements

Step therapy applies for trastuzumab agents in many product lines — providers should expect that a trial of a designated preferred agent is required for new starts unless the member is already stabilized on a non-preferred agent. Exceptions include documented intolerance to or failure of a preferred agent, or clinical rationale that the member is currently stabilized on the requested non-preferred trastuzumab.

Initial Therapy Criteria

Initial therapy

Initial therapy and preferred agent considerations

Preferred agent trial: New starts on non-preferred trastuzumab agents typically require trial and intolerance to one preferred trastuzumab agent.

'Preferred' designation and new-start definitions (e.g., no use in last 12 months) vary by line of business and effective date; consult the preferred/non-preferred listings in the policy.

Continuation and Stabilization Criteria

Continuation therapy

Continuation/stabilization exception

Stabilized on agent: Approval may be granted if the individual is currently stabilized on the requested non-preferred trastuzumab agent.

Used as an exception to step therapy requirements for ongoing therapy; applies regardless of preferred status when stability demonstrated.

Step Therapy Table and Requirements

Step	Requirement	Notes
1	New starts on a non-preferred trastuzumab agent require trial and intolerance to one preferred trastuzumab agent before approval is allowed.	Preferred agents vary by line of business and effective date; see commercial, Medicaid, and Medicare listings for preferred/non-preferred designations.
2	Exception: approval may be granted if the individual is currently stabilized on the requested non-preferred trastuzumab agent.	Stabilization exception waives the step requirement. Definitions of ‘new start’ and preferred lists may be LOB-specific (e.g., new start = no Herceptin use in prior 12 months for some plans).

Site of Care and Formulation Notes

Note

Infusion center: IV standard; Hylecta is subcutaneous

Most trastuzumab products are administered intravenously in an infusion center; Herceptin Hylecta is provided as a subcutaneous formulation with hyaluronidase (hyaluronidase-oysk).

Plan for IV infusion center administration for Herceptin and biosimilars unless using Herceptin Hylecta.
Herceptin Hylecta is administered subcutaneously with hyaluronidase-oysk.

Biosimilar Positioning and Listings

Billing Rule

Provider note: Herceptin listed as a preferred agent in some lines

Herceptin is listed as a preferred agent in certain lines of business (commercial and Medicare listings show Herceptin as preferred alongside Kanjinti on earlier effective dates). Providers should check the line-of-business list and effective date to confirm preference status before requesting a non-preferred agent.

Commercial and Medicare listings (07/01/2022 and 01/01/2025 / 09/01/2025 entries) show Herceptin as preferred alongside Kanjinti in some periods.
Preferred/non-preferred status changes by effective date and plan — verify applicable listing for the member's LOB and date of service.

Prior Authorization

Hercessi included in PA and step therapy; LOB listings vary

Hercessi (trastuzumab-strf) has been added to the prior authorization and step therapy criteria and appears on non-preferred lists in some line-of-business listings (commercial, Medicaid, and Medicare) with effective dates noted in the document history and regional listings.

Definitions

Adjuvant or adjunctive treatment — definition

Adjuvant or adjunctive treatmentTreatment given after the primary treatment to increase the chances of a cure; may include chemotherapy, radiation, hormone or biological therapy.

PurposeGiven to reduce risk of recurrence or improve cure rates following definitive primary therapy.

ExamplesMay include chemotherapy, radiation, hormone therapy, or biological therapy such as trastuzumab.

Metastasis — definition

MetastasisThe spread of cancer from one part of the body to another; a metastatic tumor contains cells like those in the original (primary) tumor that have spread.

Clinical implicationIndicates disease has disseminated beyond the primary site and may guide systemic therapy selection.

Background

Trastuzumab is a HER2‑directed monoclonal antibody indicated for tumors that overexpress the HER2/neu receptor, including certain HER2‑positive breast cancers (adjuvant and metastatic settings) and HER2‑positive metastatic gastric or gastroesophageal junction adenocarcinoma. It binds to HER2 on tumor cells to inhibit proliferation and mediate antibody‑dependent cellular cytotoxicity.

Major safety considerations include cardiotoxicity (risk of decreased left ventricular ejection fraction and cardiomyopathy, with a boxed warning), infusion‑related reactions, pulmonary toxicity, and embryo‑fetal toxicity. Trastuzumab is typically administered intravenously in an infusion center; a subcutaneous formulation combined with hyaluronidase (Herceptin Hylecta) is also available.

Revision History and Document Changes

2026-03-01Step therapy updateLatest

Step therapy table updates effective 03/01/2026 were recorded in the document history.

2026-01-01Step therapy update

Step therapy table updates effective 01/01/2026 were recorded in the document history.

2025-12-01Step therapy update

Policy Summary

PayerAnthem

PolicyTrastuzumab agents (Herceptin and biosimilars) — Clinical prior authorization and step therapy

Policy CodePolicy CC-0166

Change TypeStep therapy updatesbiosimilar added (Hercessi)

Effective DateMar 1, 2026

Next Review DateMay 16, 2025

Key ActionObtain prior authorization and document trial and intolerance to a preferred trastuzumab agent or evidence the member is stabilized on the requested non-preferred agent.

SourceLink

On This Page

Preferred agents (varies by line and effective date) — check plan-specific preferred list prior to prescribing.
Step therapy applies to new starts (e.g., no use of Herceptin in last 12 months) in some Medicare/Medicaid/Commercial lines — confirm member-specific rules.
Allowed exceptions: trial and intolerance to one preferred agent OR current clinical stabilization on the requested non-preferred agent.

Documentation Required

Documentation Required for Prior Authorization

Provide clinical documentation with PA requests to support medical necessity review. Adequate documentation expedites review and reduces denials.

Diagnosis and staging information relevant to trastuzumab therapy.
Prior treatment history including prior trastuzumab agents tried, dates, and reasons for discontinuation or intolerance.
Documentation of current stabilization on the requested non-preferred agent if claiming a stabilization exception.
Relevant pathology, HER2 test results, and supporting clinical notes or infusion records.

Denial Risk

Denial Triggers and What to Watch For

Common reasons for denial include failure to meet clinical criteria, lack of required prior authorization, and not meeting step-therapy or preferred-agent requirements. Incomplete or missing supporting documentation is a frequent denial trigger.

No PA submitted when required for the requested agent.
Requested agent is non-preferred and member has not trialed a preferred agent nor meets exception criteria.
Insufficient clinical documentation (missing diagnosis, HER2 status, prior therapy details, or stabilization evidence).

Document history notes inclusion of Hercessi to PA and step therapy criteria (select review entry).
Commercial and Medicaid/Medicare tables show Hercessi listed among non-preferred agents in specific effective-date entries.

Relation to indicationsTrastuzumab may be used for HER2-overexpressing metastatic breast cancer as noted in policy indications.

Monoclonal antibody — definition

Monoclonal antibodyA protein developed in the laboratory that can locate and bind to specific substances in the body and on the surface of cancer cells.

MechanismBinds specific antigens (e.g., HER2) to exert targeted anti-tumor effects.

Example agentsTrastuzumab (Herceptin) and its biosimilars are HER2-directed monoclonal antibodies.

Targeted biologic agent — definition

Targeted biologic agentA newer type of drug developed specifically to target genetic changes in cells that cause cancer; works differently than standard chemotherapy drugs.

Distinct featuresOften targets molecular drivers of cancer and may have different side effect profiles compared with cytotoxic chemotherapy.

RelevanceTrastuzumab is a targeted biologic agent directed at HER2-overexpressing tumors.

Step therapy table updates effective 12/01/2025 were recorded in the document history.

2025-07-23Step therapy update

Step therapy table updates effective 07/23/2025 were recorded in the document history.

2025-05-16Annual review / coding update

Annual review noted; coding reviewed with an updated description for HCPCS J9355.

2024-12-11Step therapy update

Step therapy table updates effective 12/11/2024 were recorded in the document history.

2024-06-10Select review / biosimilar addition

Select review updated criteria to include new biosimilar Hercessi to prior authorization and step therapy criteria and added HCPCS Q5146 (with note about HCPCS J3590), per document history.

2024-06-10Select review — Hercessi addedLatest

Select review updated criteria to include the biosimilar Hercessi in prior authorization and step therapy criteria (HCPCS Q5146 added for Hercessi effective 01/01/2025).