ModifiedAnthemPolicy CC-0165

Medical Drug Clinical Criteria

Clinical criteria for medical-benefit coverage (prior authorization) of Trodelvy (sacituzumab govitecan) for adults with specific breast cancer indications; includes approval and denial criteria and coding. Urothelial cancer was removed in the most recent revision.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria

Policy CodePolicy CC-0165

Change TypeRevised - indication and criteria updates

Effective DateJul 1, 2025

Next Review Date

Key ActionRequests for Trodelvy under the medical benefit require prior authorization and will be approved only when documented clinical criteria (indication-specific prior therapies and disease status) are met.

SourceLink

POLICY UPDATE CHANGES

05/16/2025 Annual Review: Remove urothelial cancer. Coding Reviewed: Removed ICD-10-CM C67.0C68.9, C79.81-C79.89, D05.00-D05.92, Z17.1.

05/17/2024 Annual Review: Update breast cancer criteria for triple negative disease after one line of therapy, update breast cancer for metastatic disease and subsequent therapy, update urothelial cancer for recurrent therapy, wording update.

2Covered breast cancer indications

1Urothelial indication removed

J9317Primary HCPCS code

Coverage Summary & Indications

Scope: Clinical criteria for medical-benefit coverage (prior authorization) of Trodelvy (sacituzumab govitecan) for adults with specified breast cancer indications, including metastatic triple-negative breast cancer (mTNBC) and select HR-positive, HER2-negative breast cancer settings. Coverage stance: covered_with_criteria — Trodelvy may be approved when the indication-specific clinical criteria and prior therapy requirements are met (see clinical criteria for mTNBC and HR-positive/HER2-negative indications).

Context/background: The policy was revised to remove the urothelial cancer indication and related ICD-10 codes effective 05/16/2025, and boxed warnings for severe neutropenia and diarrhea are noted in the background as important safety considerations.

Approved Indications / Medical Necessity Criteria

Requests for Trodelvy (sacituzumab govitecan) may be approved if the following criteria are met (Label, NCCN 2A):

ONE of the following indication groups

Metastatic or recurrent triple-negative breast cancer (mTNBC)
- Individual has recurrent or metastatic, histologically confirmed triple-negative Breast Cancer (lack of estrogen- and progesterone-receptor expression and no overexpression of HER2)
- Individual has disease progression after at least one prior lines of therapy (NCCN 1)
Unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer
- Individual has unresectable, locally advanced or metastatic, hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2)- negative breast cancer
- Individual has received endocrine based therapy
- Individual has disease progression after two prior lines of therapies
- Individual has no response to preoperative systemic therapy, metastatic, or recurrent unresectable breast cancer (NCCN 1, 2A)
- Individual is using as second-line or subsequent therapy

Not approved

Trodelvy may not be approved for the following:

ANY of the following

Individual is using in combination with an irinotecan-containing regimen or its SN-38 metabolite
When the above criteria are not met and for all other indications

Prior Authorization, Documentation & Denial Risks

Prior Authorization

Prior authorization required with clinical criteria

Requests for Trodelvy (sacituzumab govitecan) under the medical benefit require prior authorization and clinical review. Approval may be granted only when the documented clinical criteria (indication-specific prior therapies and disease status) are met. Relevant billing code: J9317 (Injection, sacituzumab govitecan-hziy, 2.5 mg).

Code: J9317

Denial Risk

Contraindicated combinations / non-approved indications

Deny Trodelvy when it is used in combination with an irinotecan-containing regimen or its SN-38 metabolite. Also deny when the listed coverage criteria (indication and prior-therapy requirements) are not met.

Documentation Required

Clinical documentation to support approval

Provide clinical documentation to support approval, including histologic confirmation of disease, receptor status (ER/PR) and HER2 status, prior therapy history specifying number and type/lines of prior therapies, and evidence of disease progression or lack of response to prior therapies as applicable.

Histologic confirmation of disease
Receptor status (ER/PR) and HER2 status
Prior therapy history (number and type/lines of prior therapies)
Evidence of disease progression or lack of response to prior therapies

Evidence & Regulatory Context

Background/Evidence: The FDA label approves Trodelvy for treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease. The NCCN provides a category 2A recommendation for recurrent triple-negative breast cancer.

Regulatory and safety notes: Trodelvy previously had an FDA indication for locally advanced or metastatic urothelial cancer which was removed from the policy on 05/16/2025. The FDA label includes a boxed (black) warning for severe neutropenia and diarrhea, and the label warns against combining or substituting Trodelvy with irinotecan or the active metabolite SN-38.

Background & Definitions

Trodelvy (sacituzumab govitecan) is a Trop-2-directed antibody-drug conjugate and topoisomerase inhibitor conjugate used primarily to treat breast cancer. It is the first Trop-2-directed antibody-drug conjugate and a targeted therapy for triple-negative breast cancer.

Approvals and label: The FDA approves Trodelvy for mTNBC in adults who have received at least two prior therapies for metastatic disease. The policy previously included an FDA approval for locally advanced or metastatic urothelial cancer, but that urothelial cancer indication was removed in the 05/16/2025 annual review.

Safety: The FDA label contains a boxed warning for severe neutropenia and diarrhea. Because Trodelvy contains, in part, the active metabolite SN-38 of irinotecan, the label warns against substituting it with irinotecan or using it in regimens that contain irinotecan or SN-38.

Disease Progression: Cancer that continues to grow or spread.

Immune checkpoint inhibitor: A type of drug that blocks certain proteins made by some immune system cells and some cancer cells; blocking these proteins releases the 'brakes' on the immune system and allows T cells to better attack cancer cells (examples include PD-1/PD-L1 inhibitors).

Policy Revision History

05/16/2025material_changeLatest

Annual Review: Remove urothelial cancer indication from the policy and delete related ICD-10 codes (Removed ICD-10-CM C67.0C68.9, C79.81-C79.89, D05.00-D05.92, Z17.1).

05/17/2024revised

Annual Review: Updated clinical wording and line-of-therapy specifications — revised breast cancer criteria for triple-negative disease after one line of therapy, updated breast cancer metastatic and subsequent therapy criteria, updated urothelial cancer recurrent therapy wording (coding reviewed: no changes).