ModifiedMass General Brigham Health PlanPolicy N/A

Herceptin (trastuzumab)

Medical-benefit prior authorization policy for Herceptin (trastuzumab) and specified biosimilars for MassHealth members, covering FDA-labeled indications including HER2-overexpressing breast cancer, metastatic gastric/GEJ adenocarcinoma, and specified colorectal cancer use when combined with tucatinib.

Policy Summary

PayerMass General Brigham Health Plan (MassHealth)

PolicyHerceptin (trastuzumab)

Policy CodePolicy N/A

Change TypeAdded biosimilar; formatting/references updated; prior indication expansion

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization under the Medical Benefit and document HER2 (or RAS WT + HER2 for mCRC), prescriber specialty, and weight-based dosing as required.

SourceLink

POLICY UPDATE CHANGES

Added new biosimilar, Hercessi (trastuzumab-strf), to criteria.

Updated formatting and references.

Expanded indication to include use of tucatinib in combination with trastuzumab for RAS WT HER2-positive unresectable/metastatic colorectal cancer (earlier change 07/12/23).

3Covered indications (breast, gastric/GEJ, colorectal)

12 monthsInitial/reauthorization duration

MassHealthPlan applicability

Prior Authorization

Coverage Summary & Scope

Key summary

Plan applicabilityMassHealth

Covered indications count3 (breast, metastatic gastric/GEJ, unresectable/metastatic colorectal)

Initial and Reauthorization Duration12 months

Program typePrior Authorization (Medical Benefit)

Initial Therapy Criteria

General Authorization

Authorization may be granted when ALL of the following are met and documentation is provided:

Member already receiving medication

Authorization may be reviewed on a case by case basis for members who are new to the plan currently receiving treatment with requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs).

Member meets indication-specific criteria below (Breast Cancer OR Metastatic Gastric/GEJ Adenocarcinoma OR Unresectable/Metastatic Colorectal Cancer).

Continuation of Therapy

Initial approvals and reauthorizations will be granted for 12 months.

Initial and Reauthorization Duration: 12 months.

Provider Actions & Authorization Rules

Prior Authorization

Prior authorization required

Prior authorization is required under the MassHealth Medical Benefit for the listed trastuzumab products. Authorization may be reviewed case-by-case for members who are new to the plan and currently receiving treatment with the requested medication, except when the product was obtained as samples or via the manufacturer's patient assistance programs.

Documentation Required

Document diagnosis and prescriber specialty

Provider must document a diagnosis of HER2-overexpressing disease (or RAS wild-type and HER2-positive for mCRC) and confirm that the prescriber is an oncologist.

Applicable Agents / Codes

Covered agents (by drug name)NDC|mixedCovered

Herceptin	trastuzumab (reference product)
Herceptin Hylecta	trastuzumab-hyaluronidase-oysk (listed in header)
Hercessi	trastuzumab-strf (biosimilar)
Herzuma	trastuzumab-pkrb (biosimilar)
Kanjinti	trastuzumab-anns (biosimilar)
Ogivri	trastuzumab-dkst (biosimilar)
Ontruzant	trastuzumab-dttb (biosimilar)
Trazimera	trastuzumab-qyyp (biosimilar)

Clinical Evidence & Definitions

Product labeling and prescribing information (Herceptin and listed biosimilars, 2024-2025) and NCCN guidelines cited.

HER2-overexpressing: Tumors with HER2 overexpression per standard diagnostic testing (per FDA labeling/NCCN guidance).

RAS wild-type (WT): Absence of RAS mutations; required for specified colorectal cancer indication.

Background

Trastuzumab is an FDA‑approved HER2 receptor antagonist for HER2-overexpressing breast cancer and metastatic gastric/GEJ adenocarcinoma. FDA-approved trastuzumab biosimilars share the same indications as the reference product. NCCN supports use per labeling and accepts FDA‑approved biosimilars as substitutes.

Revision History

2025-07-01materialLatest

Added new biosimilar, Hercessi (trastuzumab-strf), to criteria. Detail: Effective 7/1/25; reflected in list of permitted agents.

2025-06-11non-material

Updated formatting and references. Detail: Reviewed and updated for P&T on 06/11/25; formatting and reference updates noted.

2023-07-31material

Expanded indication to include use of tucatinib in combination with trastuzumab for RAS WT HER2-positive unresectable/metastatic colorectal cancer. Detail: Effective 7/31/23; included prior therapy requirements and combination use with Tukysa (tucatinib).