CurrentMass General Brigham Health PlanPolicy N/A

Trastuzumab (Herceptin) and Biosimilars Coverage Criteria

Prior authorization, step therapy, and quantity/coverage rules for Herceptin (trastuzumab) and specified biosimilars for Mass General Brigham Health Plan members under pharmacy and medical benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTrastuzumab (Herceptin) and Biosimilars Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded product + clarified step requirements

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Herceptin and listed biosimilars unless using preferred products Ogivri or Kanjinti; document HER2-overexpressing diagnosis and intolerance/contraindication to preferred biosimilars when requesting non-preferred products.

SourceLink

POLICY UPDATE CHANGES

Added Hercessi (trastuzumab-strf) to the policy and clarified preferred product step requirements.

7products covered/managed

Ogivri, Kanjintipreferred (no PA)

Herceptin + othersPA required

12 moapproval duration

Coverage Criteria

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Initial Therapy — Authorization may be granted when ALL of the following are met

Authorization may be granted when ALL of the following are met:

Initial authorization

Diagnosis: Member has one of the following diagnoses: HER2-overexpressing breast cancer OR HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
Biosimilar step requirement: Member has had an adverse effect or intolerance attributed to at least one of Ogivri or Kanjinti OR there is documentation the member has a contraindication to Ogivri and Kanjinti.
Ogivri and Kanjinti are listed as preferred products; trial of or documentation regarding these agents is required before authorizing non-preferred trastuzumab products.

Continuation Therapy — Requests for reauthorization will be approved when the following criteria are met

Requests for reauthorization will be approved when the following criteria are met:

Continuation of Therapy: Documentation of improvement in the member's condition is provided.

Initial approvals and reauthorizations will be granted for 12 months.

Ogivri and Kanjinti are designated as preferred trastuzumab products and do not require prior authorization. Other trastuzumab products listed in the policy (for example, Herceptin, Ontruzant, Trazimera, Herceptin Hylecta, Herzuma, and Hercessi) remain subject to prior authorization. Providers should select Ogivri or Kanjinti when clinically appropriate to avoid PA requirements, or document intolerance, adverse effect, or a contraindication to these preferred biosimilars when requesting authorization for a non-preferred trastuzumab product.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Herceptin and the following biosimilars unless noted as preferred: Herceptin Hylecta, Ontruzant, Trazimera, Herzuma, Hercessi.

Prior authorization required for: Herceptin; Ontruzant; Trazimera; Herceptin Hylecta; Herzuma; Hercessi

Step Therapy

Preferred Product / Step Requirement

Ogivri and Kanjinti are the preferred trastuzumab products and do not require prior authorization. Requests for non-preferred trastuzumab products (Herceptin and listed biosimilars) require stepping from preferred agents unless documentation shows intolerance or contraindication to both Ogivri and Kanjinti.

Preferred agents (no PA): Ogivri; Kanjinti
Step requirement: non-preferred trastuzumab products require trial/failure or documented intolerance/contraindication to both preferred agents

Documentation Required

Required Clinical Documentation

Requests must include documentation confirming HER2-overexpressing disease (breast or metastatic gastric/gastroesophageal junction adenocarcinoma as applicable) and supporting clinical details. For initial requests include primary diagnosis, pathology or testing demonstrating HER2 overexpression, prior treatments, and rationale for chosen trastuzumab product. For continuation/reauthorization include evidence of clinical benefit or stabilization (documentation of improvement or maintenance of response) and ongoing plan of care.

Required documentation: diagnosis and pathology/HER2 testing; prior therapy history; rationale for non-preferred product if applicable; for reauthorization: documentation of clinical improvement or maintenance

Denial Risk

Missing Clinical Criteria or Documentation — Denial Risk

Requests lacking required clinical criteria or documentation — including absence of HER2-overexpression evidence, missing intolerance/contraindication documentation to preferred products (Ogivri and Kanjinti), or failure to document prior authorization where required — may be denied.

May be denied if HER2 status not documented
May be denied if no documentation of intolerance/contraindication to Ogivri and Kanjinti when stepping is required
May be denied if PA not obtained for non-preferred agents

Background

Trastuzumab is a monoclonal antibody that binds the extracellular domain of the human epidermal growth factor receptor 2 (HER2). It is used to treat HER2-overexpressing malignancies by inhibiting tumor cell proliferation and by mediating antibody-dependent cellular cytotoxicity. The policy covers use for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

When prescribing trastuzumab products, the policy implements a preferred-product strategy: Ogivri and Kanjinti are treated as preferred biosimilars (no PA required), while other trastuzumab formulations may require documentation of intolerance, adverse effect, or contraindication to the preferred products before authorization is approved.

Definitions

inv-09: HER2-overexpressing — short definition/key-value

TermHER2-overexpressing

DefinitionDisease in which tumor cells demonstrate overexpression of the human epidermal growth factor receptor 2 (HER2), making them eligible for HER2-targeted therapy such as trastuzumab.

Covered indications (per policy)HER2-overexpressing breast cancer; HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Documentation requiredClinical evidence of HER2 overexpression (as applicable) and diagnosis matching one of the covered indications; when requesting a non-preferred trastuzumab product, documentation of adverse effect/intolerance to or contraindication to preferred biosimilars Ogivri and Kanjinti is required.

Typical approval durationInitial approvals and reauthorizations are granted for 12 months.

Initial Therapy Criteria

Initial Therapy — Initial authorization conditions (structured criteria)

Initial authorization conditions

Initial: Member has HER2-overexpressing disease (breast cancer OR metastatic gastric/gastroesophageal junction adenocarcinoma).

Authorization may be reviewed for members new to the plan within the past 90 days who are currently receiving treatment.

Step therapy requirement for non-preferred trastuzumab products: Member has experienced an adverse effect or intolerance to at least one of Ogivri or Kanjinti OR there is documentation of a contraindication to Ogivri and Kanjinti.

Ogivri and Kanjinti are preferred products and listed as no prior authorization required; trial or documentation regarding these agents is required before authorizing other trastuzumab products.

Step Therapy Requirements

Step	Requirement	Notes
{"text":"1","status":""},{"text":"Trial of or documentation regarding Ogivri (trastuzumab‑dkst) and Kanjinti (trastuzumab‑anns) is required before authorizing non‑preferred trastuzumab products (e.g., Herceptin, Ontruzant, Trazimera, Herceptin Hylecta, Herzuma, Hercessi)","status":""},{"text":"Acceptable documentation: evidence of adverse effect/intolerance to at least one of Ogivri or Kanjinti, or documentation of a contraindication to Ogivri and Kanjinti; policy updated 02/12/2025 to add Hercessi and clarify step requirements (effective 05/01/2025)","status":""}

Biosimilar Product Notes

Note

Ogivri — no prior authorization required (preferred)

Ogivri is listed as a preferred trastuzumab product and does not require prior authorization.