CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Trodelvy (sacituzumab govitecan-hziy) — Coverage Criteria

Defines coverage, inclusion and exclusion criteria, and authorization rules for Trodelvy (sacituzumab govitecan-hziy) for Neighborhood Health Plan of Rhode Island members; applies to utilization management and pharmacy authorization decisions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrodelvy (sacituzumab govitecan-hziy) — Coverage Criteria

Policy CodePolicy N/A

Change TypeMaterial clinical revision (urothelial indication withdrawn) + administrative effective date set

Effective DateJanuary 31, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Trodelvy with supporting documentation (FDA labeling, CMS compendia, or guideline/peer‑review evidence); continuation requests may be exempt if prior use within one year with no progression or intolerance.

SourceLink

POLICY UPDATE CHANGES

Urothelial cancer indication was updated to note FDA withdrawal of approval for sacituzumab govitecan-hziy on November 22, 2024.

Effective date set to January 31, 2025 and committee approval recorded 01/08/25.

J9317HCPCS

10 mg/kgDose limit

1+TNBC prior therapy

2+HR+ HER2- prior regimens

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Coverage Criteria

Initial and continuation coverage criteria

Covered when ALL of the following are met for continuation and initial indications:

Continuation exemption: For continuation requests: The requested medication was used within the last year AND the member has not experienced disease progression and/or intolerance to the requested medication AND additional medication(s) are not being added to the continuation request.

from continuation section

Breast cancer indications: Trodelvy may be used as monotherapy for either: (A) recurrent/metastatic triple negative breast cancer (ER/PR and HER2 negative) with disease progression on at least one systemic therapy regimen in the metastatic setting; OR (B) HR-positive, HER2-negative recurrent/metastatic breast cancer with disease progression on two or more chemotherapy regimens (including neoadjuvant/adjuvant regimen counted if recurrence within 12 months) and prior receipt of at least one taxane, one anticancer hormonal therapy, and one CDK4/6 inhibitor.

breast cancer inclusion criteria

Requests will be excluded or denied when any of the following apply: disease progression while receiving Trodelvy (sacituzumab govitecan-hziy); concurrent use with other anti‑cancer therapy; the member has HER2‑positive and/or ER/PR‑positive breast cancer (in the context of the TNBC indication); or dosing exceeds the single dose limit of 10 mg/kg. The policy also notes that the FDA withdrew approval for the urothelial cancer indication on November 22, 2024, which affects coverage for that diagnosis.

Use of Trodelvy for investigational or off‑label indications that lack sufficient evidence will be considered not medically necessary. Adequate supporting evidence is defined by whether the patient and disease are represented in the published literature; whether the regimen studied is relevant; whether outcomes are clinically meaningful (generally benefits in overall survival or progression‑free survival of at least 3 months); and by the quality of the evidence (randomization, trial design, sample size). Case reports and meeting abstracts without a full peer‑reviewed article generally do not meet the standard for sufficient evidence. Indications not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature will be denied.

Coding and Billing

Covered HCPCS codeHCPCSCovered

J9317

Injection, sacituzumab govitecan-hziy, 2.5 mg

inv-05: Single dose maximum

Single dose maximum10 mg/kg per single dose — dosing that exceeds this limit is an exclusion/trigger for denial

ApplicabilityApplies to Trodelvy (sacituzumab govitecan-hziy) requests as a hard dosing threshold

Action when exceededRequests with dosing above 10 mg/kg should be denied per exclusion criteria

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Trodelvy (sacituzumab govitecan-hziy) prior to initiation unless this is a continuation request that meets exemption criteria. Continuation exemption applies when the medication was used within the last year, the member has not experienced disease progression or intolerance to the medication, and no additional anticancer medications are being added to the request.

Prior authorization required for all new starts of Trodelvy.
Continuation requests may be exempt if used within last 12 months, no disease progression or intolerance, and no additional medications are added.

Denial Risk

Denial Triggers

Denial should be expected when one or more exclusion criteria are met. Common triggers for denial include disease progression while receiving Trodelvy, concurrent use with other anticancer therapy, HER2-positive and/or ER/PR-positive breast cancer, dosing above the single-dose limit, or investigational/off-label use lacking sufficient supporting evidence.

Background

Trodelvy (sacituzumab govitecan‑hziy) is an antibody‑drug conjugate used in certain metastatic breast cancer populations. It is described in this policy for monotherapy use in recurrent/metastatic triple negative breast cancer after progression on at least one systemic therapy in the metastatic setting, and for HR‑positive, HER2‑negative recurrent/metastatic breast cancer after progression on two or more chemotherapy regimens with prior receipt of a taxane, an anticancer hormonal therapy, and a CDK4/6 inhibitor. The policy also records that FDA approval for the urothelial cancer indication was withdrawn on November 22, 2024; treatment decisions should be supported by FDA labeling, CMS‑recognized compendia, and acceptable peer‑reviewed literature.

Definitions

inv-11: TNBC definition — ER/PR/HER2 negative

DefinitionTriple negative breast cancer (TNBC): estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative

Covered useTrodelvy may be used as monotherapy for recurrent/metastatic TNBC after progression on at least one systemic therapy in the metastatic setting

Exclusion noteRequests for members with HER2-positive and/or ER/PR-positive breast cancer are excluded for the TNBC indication

inv-12: HR+ HER2- breast cancer definition — hormone receptor positive and HER2 negative

DefinitionHR-positive, HER2-negative recurrent/metastatic breast cancer: hormone receptor positive (ER and/or PR positive) and HER2 negative

Coverage requirement

Initial Therapy Criteria

Initial therapy — breast cancer indications

Initial coverage for breast cancer indications — covered when ONE of the following applies:

TNBC initial: Monotherapy for recurrent/metastatic triple negative breast cancer (ER/PR and HER2 negative) after disease progression on at least one systemic therapy regimen in the metastatic setting.

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HR+ HER2- initial: Monotherapy for HR-positive, HER2-negative recurrent/metastatic breast cancer after disease progression on two or more chemotherapy regimens (neoadjuvant/adjuvant counts if recurrence within 12 months). Member must have previously received at least one taxane (e.g., paclitaxel or docetaxel), one anticancer hormonal therapy (e.g., tamoxifen), and one CDK4/6 inhibitor (e.g., palbociclib, ribociclib).

chunk 5

Continuation Therapy Criteria

Continuation therapy — continuation request exemption criteria

Continuation requests may be exempt from prior authorization when ALL of the following are met:

Continuation exemption criteria: Requested medication was used within the last year AND member has not experienced disease progression or intolerance to the medication AND no additional medications are being added to the continuation request.

from Indications for use - continuation

Step Therapy Requirements

Step	Requirement
1	Member has disease progression on or after at least two chemotherapy regimens (including neoadjuvant/adjuvant counted if recurrence within 12 months) and prior receipt of a taxane (e.g., paclitaxel or docetaxel), an anticancer hormonal therapy (e.g., tamoxifen), and a CDK4/6 inhibitor (e.g., palbociclib or ribociclib).

Quantity Limits

inv-16: Trodelvy (sacituzumab govitecan-hziy) — single dose limit 10 mg/kg

Drug and limitTrodelvy (sacituzumab govitecan-hziy) — single dose limit 10 mg/kg

Coding unitHCPCS code J9317 corresponds to sacituzumab govitecan-hziy (injection, 2.5 mg) for billing and dose calculation

Denial triggerDosing that exceeds the 10 mg/kg single dose limit is an explicit exclusion and will trigger denial