Trodelvy (sacituzumab govitecan-hziy) — HCPCS J9317
CareCost Estimate · Billing Cheat Sheet
Gilead Sciences
180 mg single-dose lyophilized vial
10 mg/kg IV D1 + D8 of 21-day cycle
Reviewed: May 2, 2026
ASP: Q2 2026
HCPCS
J9317
1 unit = 2.5 mg
Dose (80 kg)
320 units
800 mg ÷ 2.5 = 320 u
Modifier
JZ + JW
Both — weight-based + 180 mg vial
Admin CPT
96413
+ 96415 each addl hr (3hr first)
Medicare ASP+6%
$36.797
/2.5 mg unit · $11,775/800 mg
BILLER ERROR TRAP — 1 unit = 2.5 mg, NOT 1 mg. Divide total mg by 2.5 to get units. 600 mg = 240 u · 800 mg = 320 u · 1,000 mg = 400 u. Each 180 mg vial = 72 units.
Codes & NDC
| HCPCS | J9317 — "Sacituzumab govitecan-hziy" (permanent, eff. 1/1/2021; pre-2021 used J3490/J9999) · 1 unit = 2.5 mg |
|---|
| NDC | 55135-132-01 (10) / 55135-0132-01 (11) — N4 qualifier; carton-level |
|---|
| Vial | 180 mg lyophilized · reconstitute w/ 20 mL 0.9% NaCl → 10 mg/mL |
|---|
| Manufacturer | Gilead Sciences (acquired Immunomedics 2020) |
|---|
| Benefit | Medical (provider buy-and-bill); not specialty pharmacy |
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Dosing & infusion
- 10 mg/kg IV on Days 1 and 8 of every 21-day cycle
- Continue until disease progression or unacceptable toxicity
- First infusion: 3 hours (96413 + 96415 × 2)
- Subsequent: 1–2 hr if tolerated; observe ≥30 min after each
- ~17 cycles/yr = 34 infusions; year-1 ~$400K ASP+6% (80 kg)
- Premed: antiemetics (high emetogenic); consider antipyretics + H1/H2; loperamide + atropine on hand
Unit math by weight (10 mg/kg)
| Weight | Dose | Vials | JZ units | JW units |
|---|
| 50 kg | 500 mg | 3 | 200 | 16 |
| 60 kg | 600 mg | 4 | 240 | 48 |
| 70 kg | 700 mg | 4 | 280 | 8 |
| 80 kg | 800 mg | 5 | 320 | 40 |
| 90 kg | 900 mg | 5 | 360 | 0 (JZ only) |
| 100 kg | 1,000 mg | 6 | 400 | 32 |
Reconcile: JZ units + JW units must equal (vials × 180) ÷ 2.5
Administration & modifiers
| Code | When |
|---|
96413 | Chemo IV, first hour (every Trodelvy infusion) |
96415 | Chemo IV, each addl hour — required × 2 for first 3-hr dose |
96365 | NOT appropriate — Trodelvy is cytotoxic chemo |
JZ | Administered units (mg admin ÷ 2.5) |
JW | Wasted units (mg discarded ÷ 2.5) — separate line |
JZ + JW both required on most claims. Weight-based dosing + 180 mg vials = partial-vial waste is the rule.
ICD-10 by indication
| Code | Indication |
|---|
C50.x1 / C50.x2 | Breast (R/L by quadrant) — TNBC and HR+/HER2- mBC |
Z17.0 / Z17.1 | ER+ / PR+ status (HR+/HER2- only) |
C79.x | Secondary metastatic site (per disease distribution) |
C67.x | Urothelial (bladder) — verify current label status |
C65.x / C66.x / C68.x | Renal pelvis / ureter / other urinary if applicable |
Urothelial accelerated approval voluntarily withdrawn 2024 in some markets after confirmatory trial failure. Verify FDA label and payer policy before billing C67.x.
UGT1A1 testing — recommended
- SN-38 metabolized by UGT1A1; UGT1A1*28 homozygotes have higher exposure → severe neutropenia + diarrhea risk
- FDA label recommends testing; NCCN + many academic centers test before first dose
- CPT
81350 — UGT1A1 gene analysis (common variants *28, *36, *37)
- Most payers cover w/o PA; some BCBS/Anthem require for dose-reduction appeals
- Get the test BEFORE first dose to avoid retroactive documentation
Payer requirements (May 2026)
| Payer | PA | Focus |
|---|
| UnitedHealthcare | Yes | Strict line-of-therapy; receptor status; Optum site-of-care UM |
| Aetna | Yes | NCCN-aligned; UGT1A1 docs for appeals; HOPD steering after C1 |
| BCBS / Anthem | Yes | NCCN-aligned; some require UGT1A1 docs; HR+/HER2- well-established |
| Medicare | No | MAC LCDs; receptor status documentation |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $36.797 / 2.5 mg unit (= $14.72/mg) · 4/1 – 6/30/2026 |
| 800 mg dose (80 kg) | $11,775.04 (320 × $36.797) |
| 600 mg dose (60 kg) | $8,831.28 (240 × $36.797) |
| Per cycle (D1 + D8) | ~$23,550 (80 kg, 2 doses) |
| Annual (~17 cycles) | ~$400,000 (80 kg patient, before sequestration) |
Site of care
| Setting | POS | Notes |
|---|
| Physician office | 11 | Preferred (cycle 2+); 1–2 hr fits cleanly |
| Ambulatory infusion suite | 49 | Preferred |
| Hospital outpatient | 19/22 | Common for first dose (3 hr + obs); UHC/Aetna disfavor C2+ |
| Patient home | 12 | Rare for cytotoxic ADCs |
Patient assistance — Gilead Advancing Access
- Phone: 1-844-622-2377 (Gilead Advancing Access)
- Commercial copay: $5/dose, up to $25,000/year
- PAP: free Trodelvy for uninsured/underinsured (income criteria)
- Foundations (Medicare): PAN, HealthWell, CancerCare — verify open BC + bladder funds quarterly
- Web: trodelvy.com / gileadadvancingaccess.com
BOXED WARNING — severe neutropenia + severe diarrhea. SN-38 (irinotecan metabolite) toxicity. CBC before each dose; G-CSF prophylaxis often needed. Loperamide + atropine for late + acute (cholinergic) diarrhea. UGT1A1*28 homozygotes at substantially higher risk.
Pending SME review. Verify high-stakes claims against current FDA label (esp. urothelial indication status) and current payer policies before submission.