ModifiedCentenePolicy N/A

Trastuzumab/Biosimilars, Trastuzumab-Hyaluronidase (PDF)

Clinical policy describing coverage guidance and medical necessity framework for trastuzumab (and biosimilars) and trastuzumab-hyaluronidase across indications including breast, gastric/esophageal, endometrial, brain metastasis from breast cancer, appendiceal and small bowel adenocarcinoma; includes Medicaid-specific note and administrative statements.

Policy Summary

PayerCentene

PolicyTrastuzumab/Biosimilars, Trastuzumab-Hyaluronidase (PDF)

Policy CodePolicy N/A

Change TypeMultiple additions and duration revision

Effective Date06.01.16

Next Review Date

Key ActionFollow the clinical policy for medical necessity and prior authorization determinations, noting initial approval duration extended from 6 to 12 months for Medicaid and HIM.

SourceLink

POLICY UPDATE CHANGES

For gastric, esophageal and esophagogastric junction cancer, added option for use in members who are not surgical candidates per NCCN.

For endometrial carcinoma, added option for carcinosarcoma histology.

Added off-label indication for brain metastasis due to breast cancer.

Added appendiceal neoplasms and small bowel adenocarcinoma per NCCN.

For all indications for Medicaid and HIM, extended initial approval duration from 6 to 12 months.

Updated Appendix E to include Indiana and added ICHRA line.

P&T Approval Date updated to 05.26 (year not specified in this extract).

6New/Updated Indications Mentioned

12mInitial approval duration for Medicaid/HIM

2026-04-24Last review date

Coverage Summary

This clinical policy provides coverage and medical necessity guidance for trastuzumab (including biosimilars) and trastuzumab‑hyaluronidase across multiple indications — including breast, gastric/esophageal/EGJ, endometrial (including carcinosarcoma), brain metastasis from breast cancer, appendiceal neoplasms, and small bowel adenocarcinoma — describing the criteria, dosing limits, and approval durations. Coverage stance is mixed (policy includes FDA‑approved uses and NCCN‑recommended off‑label uses with specific criteria). For Medicaid members, state Medicaid provisions take precedence where conflicts exist and should be followed.

Quick Facts

New/Updated Indications Mentioned6

Initial approval duration for Medicaid/HIM12 months

Policy subjectTrastuzumab and Trastuzumab-Hyaluronidase coverage policy

Has material change (2Q 2026)Yes

Last review date2026-04-24

Medical Necessity / Criteria

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required per clinical policy

This clinical policy serves as the medical necessity guide and prior authorization determinations should follow the criteria and duration specified (initial approval duration extended from 6 to 12 months for Medicaid and HIM).

Initial approval duration for Medicaid and HIM (including ICHRA) is 12 months (changed from 6 months).

Documentation Required

Follow NCCN and state Medicaid precedence

Document indication and whether member is a surgical candidate when using trastuzumab for gastric/esophageal indications; for Medicaid members, follow state Medicaid manual when state coverage conflicts with this policy.

Document the specific indication (e.g., HER2-positive gastric, esophageal, or EGJ adenocarcinoma).

Background

This policy summarizes scope and sources used to develop the criteria: it was developed using standards of medical practice, peer‑reviewed literature, prescribing information, NCCN recommendations, and expert clinical review to define medical necessity for trastuzumab products and trastuzumab‑hyaluronidase. The document incorporates NCCN‑recommended off‑label uses and updates from the 2Q 2026 review (e.g., added brain metastasis from breast cancer; appendiceal and small bowel adenocarcinoma; carcinosarcoma histology for endometrial cancer; and surgical‑candidate language for gastric/EGJ/esophageal cancer) and specifies administrative details such as approval durations. As noted, for Medicaid members, state Medicaid coverage provisions take precedence over this policy when there is a conflict; refer to the state Medicaid manual for applicable provisions.

Revision History

2026-04-24addedLatest

For gastric, esophageal and esophagogastric junction cancer, added option for use in members who are not surgical candidates per NCCN; document surgical candidacy when requesting trastuzumab (context: last review 2026-04-24).

2026-04-24added

For endometrial carcinoma, added option for carcinosarcoma histology (off-label per NCCN).

2026-04-24added

Added off-label indication for brain metastasis due to breast cancer (NCCN-recommended use).