Trodelvy access guide: sacituzumab govitecan ADC coverage, breast-cancer indication routing, HCPCS J9317 billing, NCCN first-line TNBC placement, and payer PA criteria

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody-drug conjugate (ADC) from Gilead Sciences. Its active metabolite, SN-38 (a topoisomerase I inhibitor and the active form of irinotecan), is conjugated to a humanized anti-Trop-2 IgG1 antibody via a cleavable CL2A linker. Each antibody carries an average of seven to eight SN-38 molecules. After binding Trop-2 — overexpressed on many epithelial carcinomas — the conjugate is internalized and the linker is cleaved, releasing SN-38 intracellularly to cause DNA damage and apoptosis.

The FDA first approved Trodelvy in April 2020 for metastatic triple-negative breast cancer (mTNBC). In February 2023, the indication expanded to include pre-treated HR+/HER2-negative breast cancer. The urothelial cancer accelerated approval, granted in April 2021, was voluntarily withdrawn in November 2024 after the confirmatory TROPiCS-04 trial did not meet its overall survival endpoint. In January 2026, the NCCN added Trodelvy as a category 1 preferred first-line regimen for metastatic TNBC, supported by ASCENT-03 and ASCENT-04 data. Gilead has submitted supplemental applications to the FDA and EMA for these first-line indications.

Access teams must navigate two active breast-cancer indications with different prior-therapy requirements, UGT1A1 pharmacogenomic considerations, a withdrawn urothelial indication that still appears in some payer policies, new first-line NCCN guideline updates, and buy-and-bill billing under HCPCS J9317.

Short answer

Active FDA-approved indications

Withdrawn indication

The urothelial cancer indication withdrawal is critical for access teams: some payer policies updated as of late 2024 or 2025 now exclude urothelial cancer as a covered diagnosis for Trodelvy, while others still reference the indication with attestation language. Anthem/Elevance Health's CC-0165 policy, revised May 2025, removed urothelial cancer ICD-10 codes (C67.0–C68.9, C79.81–C79.89). Superior HealthPlan's CP.PHAR.475 update adds a provider attestation requirement acknowledging the FDA withdrawal. Payers that have not yet updated their policies may still list urothelial cancer but will typically deny claims based on the withdrawn label.

NCCN guideline updates (2026)

In January 2026, the NCCN Breast Cancer Guidelines (Version 1.2026) added Trodelvy as a category 1 preferred first-line regimen for metastatic TNBC:

• PD-L1 negative (CPS <10) and no germline BRCA1/2 pathogenic variant: Trodelvy monotherapy (category 1)
• PD-L1 positive (CPS ≥10): Trodelvy + pembrolizumab (initially category 2A, upgraded to category 1 in the February 27, 2026 update)

These recommendations are based on ASCENT-03 (monotherapy) and ASCENT-04 (combination with pembrolizumab). Gilead has submitted supplemental applications to the FDA and EMA for these first-line TNBC indications. Until FDA approval is granted for the first-line setting, payer PA criteria may not yet reflect the NCCN update, requiring appeal with guideline evidence.

Prior authorization documentation by indication

Metastatic triple-negative breast cancer (mTNBC)

Payers typically require:

1. Diagnosis confirmation: Histologically confirmed triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) documented by pathology report
2. Prior therapy documentation: At least two prior systemic therapies, at least one given for metastatic disease (per FDA label). Note: with the 2026 NCCN first-line update, some payers may begin accepting first-line use — but most current PA forms still reflect the FDA label requiring prior therapy
3. UGT1A1 testing: Patients who are UGT1A1*28 homozygous require dose reduction to 9 mg/kg. Payer criteria (e.g., Prime Therapeutics IC-0587) explicitly require that therapy will not be used in combination with irinotecan, and some require documentation of UGT1A1 status
4. Performance status: Most policies require ECOG 0–2

HR+/HER2-negative metastatic breast cancer

Payers typically require:

1. Diagnosis confirmation: HR-positive (ER+ and/or PR+) and HER2-negative defined as IHC 0, IHC 1+, or IHC 2+/ISH-negative
2. Prior therapy: Endocrine-based therapy in any setting AND at least two additional systemic therapies in the metastatic setting (including prior CDK4/6 inhibitor, per TROPiCS-02 enrollment)
3. Disease progression: Documentation of progression on or after required prior therapies

PA duration and reauthorization

• Initial authorization: Typically 6 months (Prime Therapeutics, Anthem, Aetna)
• Reauthorization: Documentation of positive clinical response (no disease progression, no unacceptable toxicity)
• Some payers (Arkansas BCBS) allow initial authorization up to 12 months

HCPCS coding and billing

Buy-and-bill economics

Trodelvy is acquired by the practice or facility and billed under the medical benefit. The WAC is approximately $20,918 per 21-day cycle (based on average 72 kg patient, 2 infusions per cycle, as of January 2026). Reimbursement is based on ASP, which typically tracks below WAC. Practices should verify acquisition cost versus expected reimbursement margin before inventory commitment.

UGT1A1 pharmacogenomics and payer questions

Sacituzumab govitecan carries SN-38, the active metabolite of irinotecan. UGT1A1 enzyme activity affects SN-38 glucuronidation and clearance. The Trodelvy label recommends a reduced dose of 9 mg/kg for patients who are UGT1A1*28 homozygous due to increased risk of severe neutropenia.

Payer implications:

• Some PA criteria (Prime Therapeutics IC-0587) require explicit attestation that Trodelvy will not be used in combination with irinotecan
• UGT1A1 genotyping is not universally required for PA approval but may be required for dose-reduction justification
• The irinotecan exclusion criterion exists because both drugs share the SN-38 metabolic pathway, increasing overlapping toxicities

Safety monitoring requirements

Gilead Oncology Support and patient assistance

Gilead Oncology Support (1-844-876-3358) provides:

• Benefits investigation: Insurance verification and coverage assessment
• Prior authorization and appeals support: Assistance with PA submissions and appeal documentation
• Gilead Oncology Co-Pay Program: Commercially insured patients may pay as little as $0 out of pocket for Trodelvy, up to $25,000 annually. Does not apply to Medicare, Medicaid, or other government programs
• Patient Assistance Program: Uninsured or underinsured patients who meet eligibility criteria may receive Trodelvy at no cost
• Third-party foundation referrals: For government-insured patients needing copay assistance

Important copay program note

Gilead's co-pay program terms include language that the company may reduce or discontinue financial assistance if it determines the patient is subject to a copay accumulator adjustment or copay maximizer program. Access teams should verify whether the patient's plan applies accumulator/maximizer logic before enrolling.

ICD-10 codes

Note: ICD-10 codes for urothelial cancer (C67.0–C68.9) have been removed from updated payer policies following the indication withdrawal.

Access friction points

1. First-line NCCN vs. FDA label mismatch: NCCN category 1 first-line recommendation exists, but FDA label still requires ≥2 prior therapies for mTNBC. Payers generally follow the FDA label, so first-line use may require appeal citing NCCN guidelines
2. Withdrawn urothelial indication lag: Some payer policies have not been updated to remove urothelial cancer, creating confusion. Others have removed it entirely. Access teams must verify the current policy version before submitting PA
3. UGT1A1 dose reduction: Patients who are UGT1A1*28 homozygous require dose reduction to 9 mg/kg, which changes billing units per dose. Ensure PA approvals reflect the correct dose
4. Irinotecan exclusion: Payer criteria universally exclude concurrent use with irinotecan. This must be documented at PA submission
5. Combination with pembrolizumab: For the NCCN-recommended Trodelvy + Keytruda combination in PD-L1-positive TNBC, separate PA is required for both drugs. Payer criteria for the combination are not yet established in most policies, as the combination is under FDA review

Sources

• Trodelvy prescribing information. Gilead Sciences, Inc. Revised March 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761115s059lbl.pdf
• FDA approves Trodelvy for previously-treated metastatic triple-negative breast cancer. FDA. April 22, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-trodelvy-sacituzumab-govitecan-hziy-previously-treated-metastatic-triple-negative
• FDA approves sacituzumab govitecan-hziy for HR-positive breast cancer. FDA. February 3, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer
• FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer. FDA. April 13, 2021. Updated November 22, 2024 (withdrawal). https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer
• Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541. https://pubmed.ncbi.nlm.nih.gov/33944817/
• TROPiCS-02: Sacituzumab govitecan in HR+/HER2- metastatic breast cancer. ClinicalTrials.gov. NCT03901339. https://clinicaltrials.gov/ct2/show/NCT03901339
• ASCENT: Sacituzumab govitecan in relapsed/refractory metastatic triple-negative breast cancer. ClinicalTrials.gov. NCT02574455. https://clinicaltrials.gov/ct2/show/NCT02574455
• Trodelvy added as preferred regimen within first-line metastatic triple-negative breast cancer in NCCN Guidelines. Gilead Sciences. January 28, 2026.
• NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. Version 1.2026. https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450
• Prime Therapeutics. Trodelvy medical necessity criteria. IC-0587. Revised June 2025.
• Aetna. Sacituzumab govitecan-hziy clinical policy bulletin. CPB 0971. https://www.aetna.com/cpb/medical/data/900_999/0971.html