Clinical Policy: Sacituzumab govitecan‑hziy (Trodelvy) coverage
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Defines medical necessity, prior authorization, and coverage criteria for sacituzumab govitecan‑hziy (Trodelvy) for Delaware First Health lines of business (Commercial, HIM/ICHRA, Medicaid). Applies to providers requesting coverage for the drug.
The FDA-approved indication for Trodelvy in metastatic urothelial cancer was voluntarily withdrawn and the use is now off-label but remains supported by NCCN; a provider attestation acknowledging the FDA withdrawal was added.
For TNBC, failure requirement for prior regimens was revised from 'two or more' to 'one or more' per NCCN, and option added to be prescribed as first-line therapy per NCCN.
Initial approval duration for all indications for Medicaid and HIM was extended from 6 to 12 months.
Coverage Criteria
Initial Therapy - Breast Cancer
Covered when ALL of the following are met for breast cancer:
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Initial Therapy - Urothelial Cancer (Off‑label)
Covered when ALL of the following are met for urothelial cancer (off‑label; provider attestation required):
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Urothelial Cancer — Withdrawal and Off-label Use
Policy updates and coverage stance for indications as described in this section
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Triple-negative Breast Cancer (TNBC) — Prior therapy and line of therapy
Updates to TNBC coverage logic
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Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the referenced off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Marketplace/ICHRA), or CP.PMN.53 (Medicaid) or other applicable evidence of coverage documents.
The manufacturer and FDA have voluntarily withdrawn the U.S. accelerated approval for sacituzumab govitecan‑hziy (Trodelvy) for treatment of adult patients with locally advanced or metastatic urothelial cancer. The withdrawal was announced October 18, 2024, and reflected in prescribing information revisions approved November 22, 2024; this indication is no longer an FDA‑approved use for Trodelvy.
Uses for indications that are not addressed by this policy — and for which the provider has not submitted sufficient off‑label efficacy and safety documentation per the referenced off‑label policies — are considered not authorized and will not be approved.
Inclusion of a code in this policy does not guarantee coverage. Claims submitted without required prior authorization or supporting documentation that demonstrate the member meets the policy criteria may be denied; providers should confirm prior authorization requirements and submit requested clinical documentation to avoid reimbursement issues.
Initial Therapy Criteria
Initial Therapy Criteria
Initial authorization criteria are diagnosis- and subtype-specific and must ALL be met as listed:
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Initial therapy dosing (breast cancer)
Dosing and initial therapy notes for breast cancer (ALL must be met):
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Continued Therapy
Continued therapy approved when ALL of the following criteria are met:
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Continuation/Renewal Criteria
Continuation Therapy
Continuation authorizations require ALL of the following to approve continued therapy:
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Approval Duration (Medicaid and HIM)
Updated approval durations (ALL apply as listed):
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Provider Actions & Documentation Requirements
Prior authorization required — include full supporting clinical details
Prior authorization is required. Submit a prior authorization request that demonstrates the member meets all applicable initial approval criteria (diagnosis, prescriber specialty/consultation with an oncologist, age ≥18 years, receptor status and indication-specific prior therapy and dosing limits). Include supporting clinical documentation as described in the policy.
- Document diagnosis (e.g., unresectable or metastatic breast cancer; or locally advanced/recurrent/metastatic urothelial cancer for off‑label consideration).
- Confirm prescriber is an oncologist or consulted with one.
- Confirm member is ≥ 18 years of age.
- Provide evidence of receptor status and prior therapies per indication.
- Provide dosing information showing dose does not exceed 10 mg/kg on days 1 and 8 of each 21‑day cycle or submit guideline/literature support for off‑label dosing.
Prior authorization required — billing code J9317
Prior authorization is required for sacituzumab govitecan‑hziy. When submitting claims, billing should use HCPCS code J9317 (Injection, sacituzumab govitecan‑hziy, 2.5 mg) as appropriate; note that PA is required before coverage is authorized.
- Include the PA approval number with claims submission to reduce risk of denial.
- Codes listed are informational—verify professional coding guidance prior to claim submission.
Therapeutic alternatives — see Appendix B
Refer to Appendix B for therapeutic alternatives and examples of prior systemic, endocrine, platinum and PD‑1/PD‑L1 therapies when documenting prior regimen history or alternative options.
- Appendix B lists exemplar cytotoxics (e.g., paclitaxel, docetaxel, capecitabine, gemcitabine), endocrine agents (e.g., tamoxifen, aromatase inhibitors), platinum combinations, and PD‑1/PD‑L1 inhibitors (e.g., pembrolizumab, atezolizumab, nivolumab, avelumab).
- Use Appendix B entries to support documentation of prior regimen failures where required by indication.
TNBC step/sequence requirements — updated prior‑regimen and first‑line options
For TNBC, document prior therapy per the revised policy: failure of one or more prior regimens is sufficient where previously two or more were required; per NCCN updates, Trodelvy may also be prescribed as a first‑line option in the situations described by the guideline.
- If prescribing Trodelvy as single agent for TNBC, document either failure of one or more prior regimens (see Appendix B) or PD‑L1 status and BRCA testing results consistent with criteria.
- If prescribing in combination with pembrolizumab, document tumor PD‑L1 CPS ≥ 10.
Required documentation — submit office notes, labs, and prior therapy details
Providers must submit documentation (such as office chart notes, lab results, pathology reports, imaging, and other clinical information) that supports the member meets all approval criteria.
- Include clinical notes confirming diagnosis, receptor status (TNBC vs HR+/HER2‑), PD‑L1 CPS where applicable, prior therapy details (agents, dates, responses), and dosing rationale.
- For dose requests exceeding 10 mg/kg or off‑label regimens, include supporting practice guideline citations or peer‑reviewed literature.
Off‑label or non‑standard dose — prescriber must submit supporting evidence
For off‑label uses or doses outside FDA limits, the prescriber must submit supporting evidence from practice guidelines (e.g., NCCN) or peer‑reviewed literature to justify the request.
- Attach relevant guideline excerpts, study citations, or literature that support the requested off‑label use or non‑standard dosing.
- Requests lacking this evidence may be delayed or denied.
Provider attestation required for withdrawn urothelial indication
When requesting coverage for metastatic urothelial cancer (now withdrawn from FDA labeling), the provider must include an attestation acknowledging the FDA's voluntary withdrawal of that indication.
- Attestation should acknowledge the October–November 2024 withdrawal and reference that the use is being considered off‑label with NCCN support.
- Include clinical rationale and prior therapy history (failure of platinum chemotherapy and PD‑1/PD‑L1 inhibitor) alongside the attestation.
Incomplete documentation may trigger denial or request for additional information
Insufficient or missing documentation at time of PA submission may result in denial or a request for additional clinical information; include all required notes and test results to prevent delays.
- Missing prior therapy documentation, PD‑L1 or BRCA test results, or lack of attestation for withdrawn urothelial use may trigger denial.
- Timely submission of complete records reduces likelihood of follow‑up requests.
Denial risk for non‑FDA indications — provide sufficient off‑label evidence
Requests for non‑FDA‑approved indications that are not addressed in this policy will not be authorized unless sufficient off‑label efficacy/safety documentation is provided in accordance with the referenced off‑label use policies.
- Follow off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) and submit guideline or literature support when seeking coverage for non‑FDA indications.
- For urothelial cancer, include the required attestation plus supporting NCCN evidence if applicable.
Coding implications — verify coding guidance; codes do not guarantee reimbursement
Codes provided in the policy (e.g., J9317) are informational and do not guarantee coverage or reimbursement; verify current professional coding guidance before submitting claims.
- Inclusion or exclusion of codes in this policy is not an authorization of payment.
- Providers should confirm correct units and billing practice for J9317 (2.5 mg units) with their billing office or coding resources.
Coding & Dosing
| J9317 | Injection, sacituzumab govitecan-hziy, 2.5 mg |
Quantity Limits & Vial Strength
Step Therapy & Prior Regimen Documentation
| Requirement | Examples / Documentation Required |
|---|---|
| Documented failure of prior systemic regimens when required by indication | Submit clinical documentation (office notes, infusion records, or chart notes) showing prior regimen names, dates, and reason for discontinuation (e.g., progressive disease or intolerance). See Appendix B for examples of systemic, endocrine, platinum, and PD‑1/PD‑L1 therapies that may satisfy prior therapy requirements. |
| For HR‑positive, HER2‑negative breast cancer: failure of endocrine‑based therapy plus two or more additional systemic regimens | Provide prior treatment history including endocrine agent(s) and at least two additional systemic regimens with dates and treatment intent (at least one prior regimen given for metastatic disease). Appendix B lists common endocrine and systemic agents. |
| For triple‑negative breast cancer (TNBC) when used as single agent: documented failure of one or more prior regimens (when applicable) | Include prior systemic therapy records indicating at least one prior regimen failure (or documentation supporting first‑line use per NCCN when applicable). See Appendix B for examples of eligible prior systemic therapies. |
| For urothelial cancer (off‑label use): documentation plus provider attestation acknowledging FDA withdrawal | Provide prior therapy documentation showing failure of platinum‑containing chemotherapy and a PD‑1/PD‑L1 inhibitor, plus a signed attestation that the prescriber acknowledges the FDA withdrawal of the metastatic urothelial cancer indication (per policy Appendix D). Examples of platinum and PD‑1/PD‑L1 agents listed in Appendix B. |
| TNBC sequencing change | Policy note / effect |
|---|---|
| Prior‑regimen failure requirement revised | Per 2Q 2024 annual review, the requirement for prior regimen failure in TNBC was changed from 'two or more' to 'one or more' prior regimens (NCCN-aligned). |
| First‑line option added per NCCN | Per 2Q 2026 annual review, an option was added to allow Trodelvy to be prescribed as first‑line therapy for TNBC when consistent with NCCN guidance; documentation should indicate rationale and any PD‑L1 testing where relevant. |
Background
Sacituzumab govitecan‑hziy (Trodelvy) is a Trop‑2‑directed antibody‑drug conjugate that delivers a topoisomerase I inhibitor payload to Trop‑2 expressing tumor cells. It is FDA‑approved for certain advanced breast cancer indications; dosing for the breast cancer indications is 10 mg/kg IV on days 1 and 8 of each 21‑day cycle. HCPCS billing for the product is referenced as J9317 (Injection, sacituzumab govitecan‑hziy, 2.5 mg) in this policy for claims submission and prior authorization purposes.
Definitions
Site of Care
Site of care — not specified in this policy section
Site‑of‑care for administration is not specified in this portion of the policy; document intended site (e.g., hospital outpatient) as required by your billing and utilization procedures.
- Policy text does not limit or require a specific site of care for Trodelvy administration in this section
- Follow applicable payer/site-of-care requirements and document site on claims
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