CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization criteria, approved indications, dosing limits, prescribing specialty requirement, and non-recommended uses for Trodelvy when billed as a medical benefit for adults with specified breast and urothelial cancers.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change Typeclarified; revised

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Trodelvy; approve those who meet the listed criteria and dosing constraints, and review off‑label dose requests case‑by‑case.

SourceLink

POLICY UPDATE CHANGES

Annual revisions updated breast cancer criteria (HR-negative and HR-positive prior therapy specifics) and added requirement that HR-positive patients not be candidates for Enhertu.

Urothelial cancer indication moved from 'FDA-approved Indications' to 'Other Uses with Supportive Evidence' following FDA withdrawal.

2Primary disease indications addressed

10 mg/kgMaximum per-dose threshold

1 yearApproval duration for indicated uses

Coverage Summary

Scope: Defines prior authorization criteria, approved indications, dosing limits, prescribing specialty requirement, and non-recommended uses for Trodelvy when billed as a medical benefit for adults with specified breast and urothelial cancers. Coverage stance: mixed. Primary indications: breast cancer (unresectable locally advanced or metastatic triple‑negative and HR‑positive/HER2‑negative) are addressed as FDA‑approved. The urothelial cancer indication was withdrawn by the manufacturer/FDA and has been moved to Other Uses with Supportive Evidence following confirmatory trial results. Approval duration: 1 year. Dosing threshold: each administered dose must be ≤ 10 mg/kg per dose. Last review date: 2025-01-08.

Quick Facts and Thresholds

Approval duration1 year

Maximum dose per administration≤ 10 mg/kg

Primary disease indications addressedBreast cancer (TNBC and HR+/HER2-) and urothelial (supportive evidence)

Initial Therapy Criteria (FDA-Approved Indications - Breast Cancer)

FDA-Approved Indications - Breast Cancer (Approve for 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

ALL of the following

Disease and prior therapy requirements
- Patient has human epidermal growth factor receptor (HER2)-negative breast cancer
- Patient is >= 18 years of age
- Hormone receptor status options
  - If HR-negative disease
    Patient has hormone receptor (HR) negative disease
    Patient has received at least one systemic regimen in the metastatic setting
  - If HR-positive disease
    Patient has hormone receptor (HR) positive disease
    Patient has tried a cyclin-dependent kinase (CDK) 4/6 inhibitor
    Patient has tried endocrine therapy
    Patient has tried at least two systemic chemotherapy regimens, one of which was tried in the metastatic setting
    Patient is not a candidate for Enhertu (fam-trastuzumab deruxtecan-nxki)
- The medication is prescribed by or in consultation with an oncologist

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FDA-Approved Indications - Breast Cancer (Approve for 1 year)

Dosing Limit (FDA-Approved Indications)

Approval dosing constraint:

ALL of the following

Each dose does not exceed 10 mg/kg administered intravenously once weekly<= 10 mg/kg per dose

Other Uses with Supportive Evidence (Urothelial Cancer)

Other Uses with Supportive Evidence - Urothelial Cancer (Approve for 1 year)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

ALL of the following

Patient is >= 18 years of age
Patient has locally advanced or metastatic urothelial cancer
Patient tried at least one systemic chemotherapy
Patient has tried at least one programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor
The medication is prescribed by or in consultation with an oncologist
Dosing: Each dose does not exceed 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle<= 10 mg/kg per dose on Days 1 and 8 of each 21-day cycle

Note: The manufacturer voluntarily withdrew the FDA urothelial cancer indication for Trodelvy after the confirmatory TROPICS-04 trial failed to demonstrate a significant overall survival benefit. Despite the withdrawal, guideline guidance (NCCN) continues to list Trodelvy as an option for subsequent‑line systemic therapy in urothelial cancer.

This change was represented in the policy by moving the urothelial indication from the 'FDA‑approved Indications' category to 'Other Uses with Supportive Evidence' to reflect the FDA withdrawal while acknowledging continued guideline support.

Not Recommended for Approval / Exclusions

Not Recommended for Approval

Coverage is not recommended when the situation is not listed in the Recommended Authorization Criteria.

Any use or circumstance not listed in the Recommended Authorization Criteria

Denial Risk

Not recommended uses

Claims for uses not listed in the Recommended Authorization Criteria are not recommended for approval and present denial risk.

Any use or circumstance not listed in the Recommended Authorization Criteria

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of Trodelvy; approval is recommended for those who meet the listed criteria and durations; requests for doses outside documented dosing will be reviewed case-by-case by a clinician.

Documentation Required

Specialty prescribing requirement

Trodelvy must be prescribed by or in consultation with a physician who specializes in the condition treated (oncologist).

Billing Rule

Dosing-related authorization constraint

Authorization requires that each administered dose does not exceed 10 mg/kg and follows specified weekly/Days 1 and 8 of 21-day cycle schedules depending on indication.

Breast cancer dosing: administered intravenously once weekly (each dose ≤ 10 mg/kg).
Urothelial cancer dosing: administered intravenously on Days 1 and 8 of each 21-day cycle (each dose ≤ 10 mg/kg).

Clinical Evidence & Guidelines

Key evidence cited: NCCN Breast Cancer Clinical Practice Guidelines (version 6.2024, Nov 11, 2024) list Trodelvy as a Preferred Regimen for metastatic triple‑negative breast cancer and as a Preferred Regimen for HR+/HER2‑ disease after specified prior therapies. NCCN Bladder Cancer Clinical Practice Guidelines (version 5.2024, Oct 28, 2024) list Trodelvy as an Other Recommended Regimen; category 2A for locally advanced/metastatic urothelial cancer. The policy also references the Trodelvy prescribing information (Gilead; November 2024).

Evidence Sources

NCCN BreastNCCN Breast Cancer guideline v6.2024 (Nov 11, 2024) — lists Trodelvy as a Preferred Regimen for metastatic TNBC and for HR+/HER2- after specified therapies

NCCN BladderNCCN Bladder Cancer guideline v5.2024 (Oct 28, 2024) — lists Trodelvy as Other Recommended Regimen (category 2A)

Prescribing informationTrodelvy prescribing information, Gilead; November 2024

Background

Background: Trodelvy (sacituzumab govitecan‑hziy) is a Trop‑2‑directed antibody‑drug conjugate that delivers a topoisomerase inhibitor payload. It is indicated for adults with unresectable locally advanced or metastatic triple‑negative breast cancer and for certain adults with HR‑positive, HER2‑negative metastatic breast cancer meeting prior therapy requirements. The manufacturer withdrew the urothelial cancer FDA indication after the confirmatory trial failed to show an overall survival benefit; however, clinical guidelines (NCCN) continue to list Trodelvy as an option for urothelial cancer in later‑line therapy.

Definitions

HRHormone receptor

HER2-negative definitionIHC 0, IHC 1+ or IHC 2-/ISH-

Examples of CDK4/6 inhibitorsKisqali (ribociclib), Ibrance (palbociclib), Verzenio (abemaciclib)

Enhertu definitionfam-trastuzumab deruxtecan-nxki (alternative therapy which HR+ patients must be not candidates for)

Revision History

02/08/2023new_indication

New FDA-labeled indication added for breast cancer: unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer after endocrine therapy and at least two additional systemic therapies in the metastatic setting.

12/20/2023criteria_modification

Criteria modified: for HR-negative disease, requirement clarified to at least one systemic regimen in the metastatic setting; for HR-positive disease, clarified that one of the two systemic regimens was tried in the metastatic setting and added requirement that HR-positive patients are not candidates for Enhertu (fam-trastuzumab deruxtecan-nxki).

01/08/2025annual_revisionLatest

Annual revision with no criteria changes; summary notes updated (annual revisions updated breast cancer criteria and added requirement that HR-positive patients not be candidates for Enhertu). Urothelial cancer indication was moved from 'FDA-approved Indications' to 'Other Uses with Supportive Evidence' following the manufacturer's withdrawal of the FDA indication (material change).

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change Typeclarified; revised

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Trodelvy; approve those who meet the listed criteria and dosing constraints, and review off‑label dose requests case‑by‑case.

SourceLink

On This Page

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary

Initial Therapy Criteria (FDA-Approved Indications - Breast Cancer)

Other Uses with Supportive Evidence (Urothelial Cancer)

Not Recommended for Approval / Exclusions

Provider Actions

Applicable Codes

Clinical Evidence & Guidelines

Background

Revision History