CurrentEmblemHealthPolicy MG.MM.PH.218

Trodelvy (Sacituzumab govitecan-hziy) Intravenous

Coverage and medical necessity criteria for intravenous Trodelvy for breast cancer (initial and renewal authorization, dosing, coding, exclusions).

Policy Summary

PayerEmblemHealth

PolicyTrodelvy (Sacituzumab govitecan-hziy) Intravenous

Policy CodePolicy MG.MM.PH.218

Change TypeMaterial updates (added safety monitoring, removed urothelial indication, clarified breast cancer criteria)

Effective Date

Next Review Date

Key ActionObtain prior authorization with clinical evidence demonstrating the member meets medical necessity criteria before initiating Trodelvy.

SourceLink

POLICY UPDATE CHANGES

Patient is at least 18 years of age; AND Therapy will NOT be substituted for or used in combination with irinotecan; AND Patients that are homozygous for the UGT1A1*28 allele will be closely monitored for adverse reactions; AND Therapy will not be used in combination with UGT1A1 inhibitors or inducers; AND Used as a single agent; AND

Removed Urothelial Cancer indication, criteria and references due to FDA indication withdrawal (10/18/24).

Breast cancer criteria were reworded to specify TNBC and HR+/HER2- pathways with explicit prior therapy lines and eligibility for fam-trastuzumab deruxtecan.

Renewal criteria now explicitly require absence of unacceptable toxicity with examples listed.

12 monthsLength of authorization

10 mg/kgDose (IV)

J9317HCPCS

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Coverage and Medical Necessity Criteria

Initial Approval Criteria

Covered when ALL of the following are met:

General requirements: Patient is at least 18 years of age; Therapy will NOT be substituted for or used in combination with irinotecan; Patients homozygous for the UGT1A1*28 allele will be closely monitored for adverse reactions; Therapy will not be used in combination with UGT1A1 inhibitors or inducers; Used as a single agent.

Breast cancer indications: Either the TNBC pathway OR the HR+/HER2- pathway as detailed in the children nodes below.

TNBC path: Patient has triple-negative breast cancer (estrogen, progesterone, and HER2-negative); AND either: (a) patient has unresectable locally advanced disease AND was previously treated with at least two systemic therapies, at least one for metastatic disease; OR (b) patient has recurrent unresectable or metastatic disease or inflammatory breast cancer with no response to preoperative systemic therapy AND was previously treated with at least one prior therapy for metastatic disease.

Supported by chunk 7

HR+/HER2- path: Patient has hormone receptor (HR)-positive, HER2-negative disease; AND patient has unresectable locally advanced or metastatic disease; AND either: (a) patient was previously treated with endocrine therapy and at least two additional lines of systemic therapy for metastatic disease; OR (b) patient has recurrent unresectable disease or inflammatory breast cancer with no response to preoperative systemic therapy AND has received prior treatment including endocrine therapy, a CDK4/6 inhibitor, and at least two lines of chemotherapy (including a taxane) with at least one given in the metastatic setting; AND patient is not a candidate for fam-trastuzumab deruxtecan.

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Renewal Criteria

Renewal covered when ALL of the following are met:

Renewal requirements: Patient continues to meet Initial Approval Criteria; AND tumor response with disease stabilization or reduction in tumor size and spread; AND absence of unacceptable toxicity from the drug (examples include severe hypersensitivity or infusion-related/anaphylactic reactions, severe nausea/vomiting, severe neutropenia or febrile neutropenia, severe anemia, severe diarrhea).

Use of Trodelvy (sacituzumab govitecan‑hziy) is not medically necessary in the following situations: when the patient is younger than 18 years of age; when there is documented disease progression while on Trodelvy; or when the requested indication is not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy also reflects that the prior urothelial cancer indication has been removed following FDA withdrawal and therefore is not an approvable indication under this coverage policy.

Additional clarifying language: requests will be denied if selection criteria in the policy are not met, including age 18 years, or if the request documents progression while the member was receiving Trodelvy. Indications lacking support from CMS compendia or acceptable peer‑reviewed literature are likewise considered not medically necessary and are not reimbursable.

Regimen	Dose / Schedule	Single-agent or Combination	Duration
Trodelvy (sacituzumab govitecan-hziy)
10 mg/kg IV on Days 1 and 8 of a 21-day cycle
Single agent
Continue until disease progression or unacceptable toxicity

Coding, Dosing, and Billing Information

Applicable Procedure CodesHCPCSCovered

J9317

Injection, sacituzumab govitecan-hziy, 2.5 mg

Applicable NDCsNDCCovered

55135-0132-01

Trodelvy ™ (sacituzumab govitecan-hziy) supplied as 180 mg of sacituzumab govitecan-hziy as lyophilized powder in a single-use vial

ICD-10 DiagnosesICD-10

C50.919	Malignant neoplasm of unspecified site of unspecified female breast
C50.929	Malignant neoplasm of unspecified site of unspecified male breast

inv-08: Dose — recommended dose and notes

Recommended dose10 mg/kg administered IV on Days 1 and 8 of a 21‑day cycle; continue until disease progression or unacceptable toxicity

Dosing frequencyOnce weekly on Days 1 and 8 of each 21‑day cycle

Maximum per-dose limitDo not administer Trodelvy at doses greater than 10 mg/kg

Administration routeIntravenous infusion

Duration of therapyContinue until disease progression or unacceptable toxicity

inv-09: Max billable units

Provider Requirements and Administrative Actions

Prior Authorization

Prior authorization required

Prior authorization is required. The request must include clinical evidence demonstrating the member meets medical necessity criteria (age, prior therapies, safety considerations, and single‑agent use).

Step Therapy

Prior therapy requirements (breast cancer)

For breast cancer, confirm and document prior lines of therapy before requesting Trodelvy: TNBC requires at least two prior systemic therapies with at least one for metastatic disease; HR+/HER2- requires prior endocrine therapy, a CDK4/6 inhibitor, and at least two additional lines of systemic chemotherapy (including a taxane) with at least one in the metastatic setting.

Documentation Required

Line of Therapy Definitions and Pathways

second-line or later

Second-line or later use: For TNBC: patient has at least two prior systemic therapies with at least one for metastatic disease (i.e., use is in the second-line or later setting).

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later-line

Later-line eligibility: For HR-positive, HER2-negative disease: patient has prior endocrine therapy, prior CDK4/6 inhibitor, and at least two lines of chemotherapy (including a taxane) with at least one given in the metastatic setting — qualifying the patient for later-line therapy per policy criteria.

Supported by chunk 7

Biomarker and Genetic Testing Requirements

inv-19: UGT1A1*28 — monitoring requirements

BiomarkerUGT1A1*28 (uridine diphosphate‑glucuronosyl transferase 1A1)*28 allele

Risk groupHomozygous carriers of UGT1A1*28 require close monitoring for adverse reactions

Monitoring requirementClosely monitor homozygous carriers for adverse reactions during therapy

Concomitant therapy cautionAvoid use in combination with UGT1A1 inhibitors or inducers (e.g., nilotinib, regorafenib, phenytoin, carbamazepine)

Background and Definitions

Trodelvy is a Trop‑2 directed antibody‑drug conjugate that delivers a topoisomerase inhibitor payload to tumor cells. It is indicated for certain patients with unresectable locally advanced or metastatic breast cancer, including triple‑negative disease after prior systemic therapies and specified HR+/HER2‑ disease per the policy. The recommended intravenous regimen in this policy is 10 mg/kg on Days 1 and 8 of a 21‑day cycle, administered as a single agent until disease progression or unacceptable toxicity.

inv-15: Trodelvy definition

Product name (generic)Trodelvy (sacituzumab govitecan-hziy)

Drug classTrop-2-directed antibody–drug conjugate delivering a topoisomerase inhibitor payload

Formulation referencedIntravenous formulation used per dosing guidance

inv-16: TNBC definition

Definition

Policy Revisions and Material Changes

2025-02-10annual_reviewLatest

Initial criteria updated to add adult age requirement (>=18), prohibition of substitution/combination with irinotecan, UGT1A1*28 monitoring guidance, prohibition of concurrent UGT1A1 inhibitors/inducers, and single‑agent use requirement.

2024-10-28renewal_revision

Renewal criteria revised to explicitly require absence of unacceptable toxicity with examples (severe hypersensitivity/infusion reactions, severe nausea/vomiting, severe neutropenia/febrile neutropenia, severe anemia, severe diarrhea).