HCPCS
J9317
1 unit = 2.5 mg
Phase 1
Identify what you're billing
Get the unit conversion right and confirm the dosing schedule before billing.
The 2.5 mg unit conversion — do not skip this CMS HCPCS verified May 2026
J9317's unit definition is unlike most J-codes. Get this wrong and the claim either rejects or pays 2.5x — both bad.
The CMS HCPCS Level II descriptor for J9317 reads simply "Sacituzumab govitecan-hziy" with a
billable unit defined as 2.5 mg. This is unusual: most monoclonal antibody and ADC J-codes use
either 1 mg or 10 mg per unit. Trodelvy's 2.5 mg unit reflects the dosing convenience the manufacturer requested
when the permanent code was issued effective January 1, 2021 (prior to that, Trodelvy billed under unclassified
J3490 / J9999).
The biller error: assuming 1 mg = 1 unit and billing the full mg amount as units. An 800 mg
dose billed as 800 units instead of 320 units is a 2.5x overstatement. Payers will either reject for impossible
unit-to-NDC ratio or (worse) pay and later recoup. Always run the conversion: units = mg ÷ 2.5.
| Patient weight | Dose at 10 mg/kg | Vials drawn (180 mg) | Drug actually billed | Discarded (waste) |
|---|---|---|---|---|
| 50 kg | 500 mg | 3 vials (540 mg drawn) | 200 units (500 mg) | 40 mg = 16 units (JW) |
| 60 kg | 600 mg | 4 vials (720 mg drawn) | 240 units (600 mg) | 120 mg = 48 units (JW) |
| 70 kg | 700 mg | 4 vials (720 mg drawn) | 280 units (700 mg) | 20 mg = 8 units (JW) |
| 80 kg | 800 mg | 5 vials (900 mg drawn) | 320 units (800 mg) | 100 mg = 40 units (JW) |
| 90 kg | 900 mg | 5 vials (900 mg drawn) | 360 units (900 mg) | 0 mg — bill JZ |
| 100 kg | 1,000 mg | 6 vials (1,080 mg drawn) | 400 units (1,000 mg) | 80 mg = 32 units (JW) |
Vial math reminder: Trodelvy comes only in 180 mg vials. Round vials up to cover the calculated
dose, then bill JZ on the administered units and JW on the discarded units. Both modifiers will appear on most
weight-based claims.
Dosing & unit math FDA label verified May 2026
From the FDA prescribing information for Trodelvy (sacituzumab govitecan-hziy), most recent revision.
Adult dosing — all approved indications
- 10 mg/kg IV on Day 1 and Day 8 of every 21-day cycle (two infusions per cycle)
- Continue until disease progression or unacceptable toxicity
- First infusion: 3 hours. Observe for at least 30 minutes after first infusion.
- Subsequent infusions: 1–2 hours if first dose tolerated. Observe at least 30 minutes after each.
Reconstitution and preparation
- Each 180 mg single-dose vial is lyophilized powder.
- Reconstitute each vial with 20 mL of 0.9% Sodium Chloride Injection → 10 mg/mL clear yellow solution.
- Calculate volume needed for the patient's dose (mg ÷ 10 = mL); withdraw and add to an infusion bag of 0.9% NaCl to a final concentration of 1.1–3.4 mg/mL.
- Use within 4 hours at room temperature or 24 hours refrigerated; protect from light.
Premedication
- Antiemetics — Trodelvy is high emetogenic potential; use a two- or three-drug combination (e.g., 5-HT3 antagonist + dexamethasone ± NK1 antagonist).
- Consider antipyretics (acetaminophen) and H1/H2 blockers (diphenhydramine, famotidine) for infusion reaction prophylaxis, especially first dose.
- Have loperamide and atropine immediately available for treatment of acute (cholinergic) and late-onset diarrhea.
Worked example — 80 kg patient with metastatic TNBC, full year
# Per-dose math
Dose: 80 kg × 10 mg/kg = 800 mg
Vials drawn: 800 / 180 = 4.44 → 5 vials (900 mg total drawn)
Drug billed: 800 / 2.5 = 320 units (J9317 + JZ)
Drug wasted: 100 mg / 2.5 = 40 units (J9317 + JW, separate line)
Admin: 96413 (first hr) + 96415 (each addl hr) × 1–2
# Per cycle (Days 1 + 8)
Doses per cycle: 2
Drug units billed per cycle: 640 administered + 80 wasted
# Year-1 (~17 cycles)
Total infusions: 34
Total drug units administered: ~10,880 units (administered)
Total drug cost (Q2 2026 ASP+6%): ~$400,392 before sequestration
Dose: 80 kg × 10 mg/kg = 800 mg
Vials drawn: 800 / 180 = 4.44 → 5 vials (900 mg total drawn)
Drug billed: 800 / 2.5 = 320 units (J9317 + JZ)
Drug wasted: 100 mg / 2.5 = 40 units (J9317 + JW, separate line)
Admin: 96413 (first hr) + 96415 (each addl hr) × 1–2
# Per cycle (Days 1 + 8)
Doses per cycle: 2
Drug units billed per cycle: 640 administered + 80 wasted
# Year-1 (~17 cycles)
Total infusions: 34
Total drug units administered: ~10,880 units (administered)
Total drug cost (Q2 2026 ASP+6%): ~$400,392 before sequestration
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
55135-132-01 / 55135-0132-01 |
180 mg lyophilized powder, single-dose vial — 1 vial per carton | All adult Trodelvy dosing — reconstitute to 10 mg/mL with 20 mL 0.9% NaCl |
Use carton-level NDC. Submit
55135-0132-01 with the N4 qualifier on the claim line.
Vial-level NDC will trigger denial. Multi-vial doses (typical) bill multiple carton-NDC quantities for the
unit-of-measure ML.
NDC unit-of-measure reminder: Each reconstituted vial yields 18 mL at 10 mg/mL. NDC quantity
on the claim should reflect total mL drawn from vials (not mg, not units). For an 800 mg dose, 5 vials ×
18 mL = 90 mL drawn from vials; the actual administered volume is 80 mL after waste.
UGT1A1 polymorphism testing FDA label / NCCN verified May 2026
Not a hard PA prerequisite for most payers, but clinically important and increasingly considered for dose-modification planning.
Trodelvy's payload is SN-38, the active metabolite of irinotecan. SN-38 is metabolized by UDP-glucuronosyltransferase 1A1 (UGT1A1). Patients homozygous for the UGT1A1*28 allele (also common in some other reduced-function variants such as *6 in East Asian populations) have substantially reduced glucuronidation, leading to higher SN-38 exposure and a meaningfully higher risk of:
- Severe (Grade 3–4) neutropenia
- Febrile neutropenia
- Severe diarrhea
- Anemia
The FDA label recommends UGT1A1 testing be considered. NCCN and major academic centers commonly test before first dose; some clinicians initiate at a reduced dose in known *28/*28 homozygotes and titrate based on tolerability.
Billing UGT1A1 testing: CPT
81350 "UGT1A1 (UDP glucuronosyltransferase 1 family,
polypeptide A1) (e.g., irinotecan metabolism), gene analysis, common variants (e.g., *28, *36, *37)" is the
standard code. Bill on a separate claim line with the patient's diagnosis + a Z-code for genetic susceptibility
if testing is preventive. Most payers cover UGT1A1 testing for irinotecan-class drugs without prior
authorization, but verify before submitting.
Not yet a universal PA gate. As of May 2026, most major payers (UHC, Aetna, BCBS) have not
elevated UGT1A1 testing to a hard prior-auth requirement for J9317 (unlike, e.g., HER2 IHC for trastuzumab).
However, payer policy is evolving — Anthem and several BCBS plans require it as part of clinical
documentation for dose-reduction justification on appeal. Get the test done before first dose to avoid
retroactive documentation scrambles.
Phase 2
Code the claim
Chemo admin codes apply — Trodelvy is a true cytotoxic ADC. JZ + JW both expected.
Administration codes CPT verified May 2026
Trodelvy delivers SN-38 intracellularly — chemotherapy administration codes are unambiguously correct.
| Code | Description | When to use |
|---|---|---|
96413 |
Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug | Primary code for every Trodelvy infusion. Covers the first 60 minutes. |
96415 |
Chemotherapy administration, IV infusion; each additional hour | Required for the first dose (3 hours total → 96413 + 2 units of 96415). Pair with 96413 for any subsequent dose extending beyond 60 minutes. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Trodelvy is a cytotoxic chemotherapy agent (SN-38 topoisomerase I inhibitor) by AMA classification. |
96360 / 96361 |
Hydration IV | Bill separately if IV hydration administered alongside infusion (e.g., for cholinergic diarrhea management). Use modifier 59 / X-modifier as appropriate. |
Infusion-time math: First-dose 3-hour infusion bills 96413 × 1 + 96415 × 2.
Subsequent 2-hour infusions bill 96413 × 1 + 96415 × 1. Subsequent 1-hour infusions bill 96413
× 1 only. Document actual infusion start/stop times in the medical record — CMS audits look for
chair-time documentation matching billed units.
Modifiers CMS verified May 2026
JZ + JW — both apply on most claims
Effective July 1, 2023, CMS requires either JZ (no waste) or JW (drug discarded from a single-dose container) on every J9317 claim. Because Trodelvy is dosed by weight (10 mg/kg) and only available in 180 mg single-dose vials, partial-vial waste is the rule, not the exception.
- JZ on the administered units (the actual mg given to the patient, divided by 2.5).
- JW on the discarded units (drawn-but-not-administered mg, divided by 2.5), reported on a separate claim line.
- Both lines must reconcile against the total mg drawn from vials (vials drawn × 180 = total mg drawn = administered + wasted).
Worked example — 80 kg patient, 800 mg dose
# Vials and waste
Vials drawn: 5 × 180 mg = 900 mg total
Administered: 800 mg = 320 units → J9317-JZ
Discarded: 100 mg = 40 units → J9317-JW
# Claim lines
Line 1: J9317-JZ × 320 units
Line 2: J9317-JW × 40 units
Line 3: 96413 (admin, first hr)
Line 4: 96415 (admin, addl hr) × 1–2 depending on infusion time
Vials drawn: 5 × 180 mg = 900 mg total
Administered: 800 mg = 320 units → J9317-JZ
Discarded: 100 mg = 40 units → J9317-JW
# Claim lines
Line 1: J9317-JZ × 320 units
Line 2: J9317-JW × 40 units
Line 3: 96413 (admin, first hr)
Line 4: 96415 (admin, addl hr) × 1–2 depending on infusion time
Common error: Forgetting the JW line entirely, or computing JW units in mg instead of in 2.5 mg
units. Always: convert mg waste to units first (mg ÷ 2.5), then bill the JW line. CMS audits routinely
catch under-reported waste and over-reported waste — both are recoupable.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion (e.g., toxicity assessment with dose modification decision). Routine pre-infusion clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Trodelvy, follow your MAC's current 340B modifier policy. As of May 2026, JG (340B-acquired, normal payment) and TB (340B-acquired, informational) policy varies by region; verify with your MAC.
ICD-10-CM by indication FY2026 verified May 2026
Use the most specific code supported by encounter documentation; pair breast cancer codes with appropriate ER/PR/HER2 status Z-codes.
| Indication | Primary ICD-10 | Required supporting codes |
|---|---|---|
| Metastatic TNBC | C50.x1 (right breast) / C50.x2 (left breast) by quadrant |
C79.x (secondary metastatic site) per disease distribution; ER-/PR-/HER2- status documentation in chart |
| HR+/HER2- mBC | C50.x1 / C50.x2 by quadrant |
Z17.0 (estrogen receptor positive) and/or Z17.1 (progesterone receptor positive); HER2- documentation in chart; C79.x for metastatic sites |
| Locally advanced or metastatic urothelial cancer | C67.x by anatomic location (bladder) |
C65.x (renal pelvis) / C66.x (ureter) / C68.x (other urinary) if applicable; C79.x for metastatic sites |
Common breast cancer C50 codes by quadrant
| Code family | Location |
|---|---|
C50.0x | Nipple and areola |
C50.1x | Central portion of breast |
C50.2x | Upper-inner quadrant |
C50.3x | Lower-inner quadrant |
C50.4x | Upper-outer quadrant |
C50.5x | Lower-outer quadrant |
C50.6x | Axillary tail |
C50.8x | Overlapping sites |
C50.9x | Unspecified |
Indication-specific PA criteria are the norm. Most payers require ICD-10 + line of therapy
documentation + receptor status (for breast cancer) + prior-therapy documentation. ICD-10 alone is not sufficient
for PA approval — you must show the patient meets the post-line-of-therapy criteria for each indication.
Urothelial indication status: The accelerated approval for urothelial cancer was voluntarily
withdrawn in some markets in 2024 following confirmatory trial results. Verify the current FDA label and your
payer's medical policy before billing J9317 with C67.x ICD-10. Payers may reject urothelial claims even with
clean documentation if the indication has been removed from current label.
Site of care & place of service Verified May 2026
Trodelvy's first-dose 3-hour infusion plus 30-minute observation typically requires an infusion suite or physician oncology office. Subsequent 1–2 hour infusions are office-friendly. Major commercial payers (UnitedHealthcare, Aetna, BCBS) run aggressive site-of-care UM steering specialty oncology drugs out of HOPD.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Physician oncology office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Oncology ASC | 24 | CMS-1500 / 837P | Acceptable |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first cycle by most commercial UM |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored after first cycle by most commercial UM |
| Patient home | 12 | CMS-1500 (with home infusion) | Rare for cytotoxic ADCs; toxicity monitoring favors clinic |
First-dose recommendation: Many oncology practices schedule the first Trodelvy dose in a
hospital outpatient or AIC with overnight observation capability given the boxed warning toxicities. Subsequent
doses transition to office once tolerability is established. Document this clinical rationale in chart for any
HOPD site-of-care UM appeal.
Claim form field mapping Gilead Reimbursement Guide 2026
Every Trodelvy claim with weight-based dosing has at least two J9317 lines — JZ and JW. Account for both.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 55135-0132-01 + ML + total volume drawn (e.g., 90 mL for 5 vials) |
| HCPCS J9317 + JZ (administered units) | 24D (drug line 1) | Units = administered mg ÷ 2.5 |
| HCPCS J9317 + JW (wasted units) | 24D (drug line 2) | Units = discarded mg ÷ 2.5; required when partial-vial waste occurs |
| Drug units | 24G | Per line; ensure JZ + JW units sum to total drawn mg ÷ 2.5 |
| CPT 96413 (admin line) | 24D (admin line 1) | First hour of infusion |
| CPT 96415 (admin line) | 24D (admin line 2–n) | Each additional hour; required for first 3-hour dose, often for 2-hour subsequent doses |
| ICD-10 | 21 | Indication-specific (see ICD-10 table); pair with C79.x metastatic-site codes and Z-codes for receptor status |
| UGT1A1 test claim line (if same-encounter) | 24D | CPT 81350 on a separate line if billed |
| PA number | 23 | Required by all major commercial payers |
Phase 3
Get paid
Confirm payer coverage of HR+/HER2- indication (newer) and verify urothelial label status before billing.
Payer policy snapshot Reviewed May 2026
All major payers require PA. The HR+/HER2- indication (Feb 2023) is newer — some payers are still tightening criteria.
| Payer | PA? | Documentation focus | Site-of-care UM |
|---|---|---|---|
| UnitedHealthcare Oncology Med Coverage Policy |
Yes | Strict for line of therapy: TNBC requires ≥2 prior systemic incl. taxane; HR+/HER2- requires endocrine + ≥2 prior chemo for metastatic; biomarker docs (ER, PR, HER2) required in PA | Aggressive: ICI/ADC steering away from HOPD via Optum-managed program |
| Aetna Medical Drug policies |
Yes | Aligned with NCCN Breast Cancer guidelines + FDA label; receptor status required; UGT1A1 documentation requested for dose-reduction appeals | Yes (separate Site-of-Care policy; cytotoxic ADCs steered out of HOPD after first cycle) |
| BCBS plans Vary by plan |
Yes | Generally aligned with NCCN guidelines + FDA label; some plans (Anthem) require UGT1A1 testing documentation; HR+/HER2- coverage well-established by 2026 | Plan-specific; most have ICI/ADC site-of-care steering after first cycle |
| Medicare All MACs — LCDs |
No (Part B medical benefit) | All MACs cover J9317 for FDA-approved indications with appropriate ICD-10 and biomarker (receptor status) documentation | Limited; Medicare has no formal site-of-care UM |
Step therapy
Trodelvy is a later-line therapy by FDA label design (post-2 prior systemic for TNBC, post-endocrine + 2 prior chemos for HR+/HER2-). Step therapy requirements are typically baked into the line-of-therapy documentation, not enforced as a separate gate. Expect payers to require evidence of prior taxane exposure for TNBC and prior CDK4/6 inhibitor exposure for HR+/HER2- in the PA submission.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J9317
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$36.797
per 2.5 mg unit (= $14.72/mg)
800 mg dose (80 kg)
$11,775.04
320 units × ASP+6%
600 mg dose (60 kg)
$8,831.28
240 units × ASP+6%
Annualized cost (80 kg patient, 10 mg/kg D1+D8 q21d): 2 doses per cycle × ~17 cycles
per year = 34 infusions; ~$400,000/year drug cost at Medicare ASP+6% before sequestration
and before counting wasted-vial JW reimbursement (which adds modestly). After ~2% sequestration: ~$392,000/year
actual paid.
Coverage
No NCD specific to sacituzumab govitecan-hziy. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9317 for FDA-approved on-label indications with appropriate ICD-10 and biomarker (breast cancer receptor status) documentation.
Code history
- Pre-2021 — Trodelvy billed under unclassified
J3490/J9999with NDC and dose documentation following the April 2020 accelerated approval - J9317 — permanent code, effective January 1, 2021, "Sacituzumab govitecan-hziy," 1 unit = 2.5 mg
Patient assistance — Gilead Advancing Access Gilead verified May 2026
- Gilead Advancing Access: 1-844-622-2377 / advancingaccess.com — benefits investigation, prior authorization assistance, appeal support, referral to copay and patient assistance programs
- Trodelvy Co-pay Coupon Program: commercially insured patients pay $5 per dose, up to $25,000 per calendar year in support (excludes Medicare, Medicaid, federal program patients)
- Gilead Patient Support Program: free Trodelvy for uninsured / underinsured patients meeting income criteria, administered through Gilead's patient assistance foundation
- Foundations for Medicare patients: refer to PAN Foundation, HealthWell Foundation, CancerCare — verify open breast cancer and bladder cancer copay funds quarterly (oncology fund availability is highly volatile)
- Web: trodelvy.com / gileadadvancingaccess.com
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and
OOP max? Run a CareCost Estimate — J9317 pre-loaded.
Phase 4
Fix problems
Unit-conversion errors, missing JW lines, and urothelial-indication confusion are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Units don't match NDC quantity | Billed mg as units instead of converting to 2.5 mg units (2.5x overstatement) | Resubmit with units = administered mg ÷ 2.5. Verify NDC ML quantity matches vials drawn. |
| JW missing on weight-based claim | Wasted drug not reported when partial-vial waste occurred | Add JW line with discarded units (mg wasted ÷ 2.5). JZ on administered units; JW on wasted. |
| JZ + JW units don't reconcile to vials drawn | Math error: JZ + JW units × 2.5 should equal vials drawn × 180 mg | Recompute: total mg drawn = vials × 180; administered mg ÷ 2.5 = JZ units; (drawn mg − admin mg) ÷ 2.5 = JW units. |
| Wrong admin code (96365) | Therapeutic IV billed instead of chemo IV | Resubmit with 96413 + 96415 as appropriate. Trodelvy is cytotoxic chemotherapy by AMA classification. |
| Missing 96415 on first-dose 3-hour infusion | Only 96413 billed for first dose; 2 hours of additional infusion time not captured | Add 96415 × 2 for first dose. Document infusion start/stop times. |
| Wrong NDC format (vial vs carton) | Vial NDC submitted instead of carton NDC | Use carton NDC: 55135-0132-01 with N4 qualifier. |
| Site of care (HOPD) | HOPD administration after first cycle on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49) for cycle 2+. Submit medical necessity letter if HOPD required (e.g., active toxicity management). |
| Indication-specific PA criteria not met | ICD-10 alone insufficient; line-of-therapy or receptor status not documented | Submit complete clinical history including receptor status, prior endocrine therapy, prior chemo regimens, and current line of therapy. |
| Urothelial indication denied | Payer policy reflects post-2024 withdrawal of urothelial accelerated approval | Verify current FDA label and payer policy. May require off-label PA with NCCN compendium support if urothelial use continues. |
| UGT1A1 test denied | Test billed without supporting Dx or as routine screening | Bill CPT 81350 with the patient's cancer Dx and Z-code for genetic susceptibility; document clinical rationale in chart. |
Frequently asked questions
What is the HCPCS code for Trodelvy?
Trodelvy (sacituzumab govitecan-hziy) is billed under HCPCS J9317 — "Sacituzumab
govitecan-hziy." One billable unit equals 2.5 mg, NOT 1 mg. This unusual unit-to-mg conversion
is the single most common Trodelvy biller error. A 720 mg dose bills as 288 units, not 720. J9317 has been
effective since January 1, 2021. Pre-2021 doses billed under unclassified J3490 or J9999.
How many units do I bill for a Trodelvy dose?
Divide total mg administered by 2.5. Examples: 60 kg patient × 10 mg/kg = 600 mg = 240 units; 80 kg patient × 10 mg/kg = 800 mg = 320 units; 100 kg patient × 10 mg/kg = 1,000 mg = 400 units. Each 180 mg vial = 72 units. Round mg to nearest convenient mg per institutional policy, then convert to units.
What administration CPT do I use for Trodelvy?
CPT 96413 for the first hour of infusion, plus 96415 for each additional hour. First
infusion is 3 hours total (96413 + 96415 × 2). Subsequent 1–2 hour infusions: 96413 alone (1 hr)
or 96413 + 96415 × 1 (2 hr). Do NOT bill 96365 — Trodelvy is a true cytotoxic ADC (SN-38 is a
topoisomerase I inhibitor) and chemo administration codes apply per AMA classification.
Do I bill JZ or JW for Trodelvy?
Both, on most claims. JZ on the administered units, JW on the discarded units. Because Trodelvy is dosed by weight (10 mg/kg) and only available in 180 mg single-dose vials, partial-vial waste is the rule. Example: an 800 mg dose uses 5 vials (900 mg drawn); 100 mg discarded = 40 units of waste billed JW on a separate line. One of JZ or JW must be on every J9317 claim per CMS's July 2023 single-dose container policy.
What is the Medicare reimbursement for J9317?
For Q2 2026, the Medicare Part B payment limit for J9317 is $36.797 per 2.5 mg unit (= $14.72 per mg) at ASP + 6%. A typical 800 mg dose for an 80 kg patient at 10 mg/kg = 320 units × $36.797 = $11,775.04 per dose. With Days 1 + 8 of each 21-day cycle, that's two doses per cycle (~$23,550 per cycle), and approximately 17 cycles per year = ~$400,000/year drug cost (ASP + 6%) before sequestration.
What are Trodelvy's FDA-approved indications?
Three approved indications: (1) metastatic TNBC in adults post ≥2 prior systemic therapies (≥1 for metastatic) — accelerated approval April 2020, full approval April 2021; (2) HR+/HER2- metastatic breast cancer in adults post-endocrine therapy and ≥2 additional systemic therapies in metastatic setting — approved February 2023; (3) locally advanced / metastatic urothelial cancer post-platinum and post-PD-1/L1 inhibitor — this accelerated approval was voluntarily withdrawn in some markets in 2024 after confirmatory trial failure; verify current label status before billing for urothelial indication.
Does Trodelvy have a boxed warning?
Yes. The boxed warning covers (1) severe or life-threatening neutropenia — CBC monitoring before each dose, prophylactic G-CSF in patients with febrile neutropenia or grade 4 neutropenia — and (2) severe diarrhea — early intervention with loperamide for late-onset diarrhea and atropine for cholinergic-type acute diarrhea. UGT1A1 polymorphism testing is recommended; UGT1A1*28 homozygous patients have higher SN-38 exposure and substantially increased risk of severe neutropenia and diarrhea, and may benefit from initial dose reduction. Premedication with antiemetics is recommended.
What patient assistance is available for Trodelvy?
Gilead's umbrella program is Advancing Access (1-844-622-2377). Commercially insured patients access the Trodelvy Co-pay Coupon Program ($5 per dose, up to $25,000/year). Uninsured/underinsured patients meeting income criteria can receive Trodelvy free of charge through the Gilead Patient Support Program. Medicare patients should be referred to PAN Foundation, HealthWell Foundation, and CancerCare for breast and bladder cancer copay funds — verify open funds quarterly.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — TRODELVY (sacituzumab govitecan-hziy) Prescribing Information
- FDA Drugs@FDA — Trodelvy BLA 761115
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS Quarterly Update
- SEER CanMED — HCPCS J9317 reference
- Gilead Advancing Access — reimbursement and patient assistance hub
- Trodelvy.com — HCP and patient resources
- UnitedHealthcare — Oncology Medication Clinical Coverage Policy
- Aetna Medical Drug policies — oncology
- NCCN Clinical Practice Guidelines in Oncology — Breast Cancer (V.2.2026)
- FDA National Drug Code Directory
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules + UGT1A1 test code | Annual | Reviewed against CMS HCPCS quarterly files, AMA CPT releases, and Category III code updates. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. Urothelial indication status under active monitoring after 2024 confirmatory trial. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS, manufacturer,
payer documents — all linked above). Editorial review in progress.
Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026 ($36.797 per 2.5 mg unit). Manufacturer source: Gilead Advancing Access 2026 + Trodelvy.com. FDA label: most recent revision. Three indications referenced: TNBC (full approval Apr 2021), HR+/HER2- mBC (Feb 2023), urothelial (verify current label status given 2024 partial withdrawal). Boxed warning + UGT1A1 testing called out prominently. Unusual 2.5 mg unit conversion flagged as primary biller error trap.
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list is verified against the current FDA label revision. We do not paraphrase from billing-software vendor blogs.