CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Trodelvy (sacituzumab govitecan-hziy)

Defines accepted indications, contraindications, exclusions, and coding for Trodelvy (sacituzumab govitecan-hziy) including FDA-approved and select off-label uses; applies to medication request processing by Evolent for Neighborhood Health Plan of Rhode Island across listed lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTrodelvy (sacituzumab govitecan-hziy)

Policy CodePolicy N/A

Change TypeTemplate revision; FDA withdrawal note retained

Effective DateJan 1, 2026

Next Review Date

Key ActionMedication requests must be processed and authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

Added FDA withdrawal note under urothelial cancer indication regarding final withdrawal dated November 22, 2024.

Converted to new Evolent guideline template and replaced prior UM ONC_1407 Trodelvy policy.

1Primary HCPCS code listed

2Covered breast cancer indications

1Regulatory withdrawal noted (urothelial cancer)

Coverage Summary & Eligible Indications

Scope: This policy applies to members receiving Trodelvy (sacituzumab govitecan-hziy) for approved and accepted oncologic indications per FDA labeling, CMS-recognized compendia, NCCN/ASCO guidance, or peer-reviewed literature. Coverage stance: Trodelvy is covered when the clinical criteria below are met for eligible breast cancer indications; use for urothelial cancer is addressed as a regulatory notice. Accepted uses (high-level): monotherapy for recurrent/metastatic triple negative breast cancer (TNBC) after progression on at least one systemic therapy in the metastatic setting, and monotherapy for hormone receptor (HR) positive / HER2-negative recurrent/metastatic breast cancer after disease progression on ≥2 prior chemotherapy regimens (with specific prior therapy requirements). Regulatory note: FDA withdrew the approval for urothelial cancer; requests for sacituzumab govitecan-hziy for urothelial cancer should reflect this withdrawal and be reviewed against current regulatory and guideline sources. Effective date: 2026-01-01. Last review/implementation: January 2026.

Breast Cancer - Eligible Indications

Triple Negative Breast Cancer (TNBC)
- Diagnosis of recurrent or metastatic triple negative breast cancer (ER/PR negative and HER-2 negative).
- Documented disease progression on at least one prior systemic therapy regimen in the metastatic setting (adjuvant/neoadjuvant therapy that preceded metastatic disease does not count unless recurrence occurred during or within 12 months of completion and is being considered as part of prior regimen history).
- Trodelvy to be used as monotherapy.
- Dosing does not exceed single dose limit of 10 mg/kg (exclusion criterion).
  Operational: verify weight-based dosing and single-dose limits in administration documentation.
HR positive / HER-2 negative breast cancer
- Diagnosis of recurrent or metastatic breast cancer that is HR positive (ER and/or PR positive) and HER-2 negative.
- Documented disease progression after 2 or more prior chemotherapy regimens for recurrent/metastatic disease. Prior neoadjuvant/adjuvant chemotherapy may count as one regimen if disease recurrence occurred within 12 months of completing that therapy.
- Prior therapy must include at least one Taxane (e.g., paclitaxel or docetaxel), at least one anticancer hormonal therapy (e.g., tamoxifen, aromatase inhibitor), and at least one CDK4/6 inhibitor (e.g., palbociclib, ribociclib).
- Trodelvy to be used as monotherapy.
- Dosing does not exceed single dose limit of 10 mg/kg (exclusion criterion).
  Operational: verify prior systemic therapy history and dosing limits in prior authorization documentation.

Continuation Therapy Criteria & Exceptions

Continuation Therapy (exceptions to non-approvable medications)

Continuation requests for a not-approvable medication shall be exempt provided ALL are met:

ALL of the following

The member has not experienced disease progression on the requested medication
The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization
Additional medication(s) are not being added to the continuation request

Documentation Required

Continuation request criteria

Continuation request criteria Document that all three of the following are met for continuation of a not-approvable medication: - The member has not experienced disease progression on the requested medication. - The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization. - Additional medication(s) are not being added to the continuation request. Also document relevant thresholds when applicable (e.g., ANC for withholding and dosing limits).

No disease progression on the requested medication.
Used within the last year with no >30-day lapse from prior authorization.
No additional medications being added to the continuation request.
Reference ANC withholding threshold: withhold for ANC < 1,500/mm3.
Reference dosing single-dose limit: 10 mg/kg (do not exceed).

Contraindications, Warnings & Exclusions

Contraindications / Warnings

Do not use when any of the following apply:

ANY of the following

Severe hypersensitivity to sacituzumab govitecan-hziy or any component of the formulation
ANC threshold: Absolute neutrophil count (ANC) below 1,500/mm3 — withhold for ANC < 1,500/mm3 or neutropenic fever< 1,500/mm3
Withhold for ANC below threshold or neutropenic fever
Severe diarrhea — withhold until resolved to ≤ Grade 1 and reduce subsequent doses

Exclusion Criteria / Not Medically Necessary

Trodelvy is excluded when any of the following are present:

ANY of the following

Disease progression while receiving Trodelvy (sacituzumab govitecan-hziy)
Concurrent use with other anti-cancer therapy
Member with HER-2 positive and/or ER/PR positive breast cancer
Dosing exceeds single dose limit of Trodelvy 10 mg/kg10 mg/kg
Single dose limit
Investigational / insufficient evidence
- Off-label indication not supported by sufficient evidence or not generally accepted by the medical community

Denial Risk

Exclusion risk conditions

Exclusion risk conditions Conditions that place requests at high risk for denial include: - Dosing that exceeds the single dose limit (10 mg/kg). - Concurrent use with other anti-cancer therapy. - Disease progression while receiving Trodelvy. - Member with HER-2 positive and/or ER/PR positive breast cancer. - Use for investigational or off-label indications not supported by sufficient evidence (see definition of sufficient evidence).

Dosing > single dose limit of 10 mg/kg.
Concurrent anti-cancer therapy.
Disease progression on Trodelvy.
HER-2 positive and/or ER/PR positive breast cancer.
Investigational or off-label use not supported by sufficient evidence (CMS compendia, acceptable peer-reviewed literature, NCCN/ASCO standards).

Prior Authorization, Documentation & Billing

Prior Authorization

Evolent prior authorization required

Evolent prior authorization required Medication requests must be processed and authorized by Evolent. Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

All Trodelvy medication requests must be processed and authorized by Evolent.
Medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Documentation Required

Support with recognized evidence

Support with recognized evidence Requests must be supported by recognized sources of evidence. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, NCCN, ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. "Sufficient evidence" is defined by CMS compendia, NCCN/ASCO or acceptable peer-reviewed literature and considerations including representativeness of patients/regimens, clinically meaningful outcomes (e.g., ASCO definitions), appropriateness of study design, and limitations of case reports/abstracts/meeting abstracts.

FDA-approved product labeling (prescribing information).
CMS-recognized compendia.
NCCN guidelines and compendia.
ASCO clinical guidelines.
Acceptable peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.
Definition of "sufficient evidence": CMS compendia / acceptable peer-reviewed literature with considerations for representativeness, regimen representation, clinically meaningful outcomes (ASCO guidance), study design appropriateness, and exclusion of case reports/abstracts as sole evidence.

Denial Risk

Exclusion risk conditions

Exclusion risk conditions Summarizes denial risk if any of the following are present: dosing over 10 mg/kg, concurrent anti-cancer therapy, disease progression while on Trodelvy, or tumor biomarker status inconsistent with approved/accepted use (HER-2 positive and/or ER/PR positive). Also includes investigational/off-label use lacking sufficient evidence.

Dosing exceeding 10 mg/kg.
Concurrent use of other anti-cancer therapy.
Disease progression on Trodelvy.
Wrong tumor biomarker status (HER-2 positive and/or ER/PR positive breast cancer).
Investigational/off-label indications not supported by sufficient evidence as defined by CMS compendia and acceptable peer-reviewed literature.

Clinical Evidence & References

Key trials/references: ASCENT (metastatic triple-negative breast cancer) — Bardia et al., N Engl J Med; TROPiCS-02 (hormone receptor–positive, HER2‑negative metastatic breast cancer) — Rugo et al., Lancet; TROPHY-U-01 (metastatic urothelial carcinoma) — Tagawa et al., J Clin Oncol; Trodelvy prescribing information (Gilead Sciences, 2025/2026).

Additional supporting sources include the IMMU-132-01 basket trial safety/efficacy results and listed compendia and guideline resources referenced in the guideline (e.g., NCCN, ASCO, Clinical Pharmacology).

Billing/code reference: HCPCS code J9317 (Injection, sacituzumab govitecan-hziy, 2.5 mg).

Background & Definitions

Evolent Clinical Guideline purpose: To define and describe accepted indications for Trodelvy, including FDA-approved and select off-label uses, and to establish prior authorization requirements and processing responsibilities for Evolent when reviewing medication requests.

Continuity/continuation rule rationale: Continuation requests for a not-approvable medication may be exempt when the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of having an active authorization, and no additional medications are being added to the continuation request — allowing clinically appropriate ongoing therapy while avoiding abrupt treatment interruptions.

Reference to recognized evidence sources: Use must be supported by FDA labeling, CMS‑recognized compendia, NCCN, ASCO clinical guidelines, or acceptable peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards.

Thresholds & Regulatory Note

Single dose limit10 mg/kg

ANC threshold for withholding< 1,500/mm3

Regulatory noteFDA announced final withdrawal of approval for sacituzumab govitecan-hziy (Trodelvy) for locally advanced or metastatic urothelial cancer (announcement dated November 22, 2024)

Continuation request exemption: Allowance to continue a not-approvable medication if the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and additional medication(s) are not being added to the continuation request.

Sufficient evidence: Evidence supported by CMS compendia, NCCN/ASCO or acceptable peer‑reviewed literature and meeting clinical meaningfulness considerations (for example, ASCO definitions such as hazard ratio thresholds and recommended survival benefit), and assessment of representativeness of patient/cancer characteristics, regimen representation, study design appropriateness, and limitations of case reports/abstracts.

Revision History

January 2026implementationLatest

Converted to new Evolent guideline template, replaced prior UM ONC_1407 Trodelvy policy, updated indication section and references; implementation dated January 2026.

January 2025regulatory_note_added

Added FDA withdrawal note under the urothelial cancer indication stating that on November 22, 2024 the FDA announced the final withdrawal of approval of sacituzumab govitecan-hziy (Trodelvy) for adult patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.