Datroway (datopotamab deruxtecan-dlnk) — HCPCS J9011
CareCost Estimate · Billing Cheat Sheet
Daiichi Sankyo (w/ AstraZeneca)
100 mg single-dose lyophilized vial
6 mg/kg IV q21d
Reviewed: May 21, 2026
ASP: Q2 2026
Dose (75 kg)
450 units
450 mg = 6 mg/kg
Modifier
JZ + JW
Both — weight-based + 100 mg vial
Admin CPT
96413
+ 96415 first dose only (90 min)
Medicare ASP+6%
$51.516
/mg · $23,182/450 mg dose
DON'T CONFUSE WITH TRODELVY (J9317). Both are TROP-2 ADCs. J9011 = 1 unit/mg, 6 mg/kg q21d, deruxtecan payload. J9317 = 1 unit/2.5 mg, 10 mg/kg D1+D8 q21d, SN-38 payload. Verify HCPCS matches actual product dispensed.
Codes & NDC
| HCPCS | J9011 — "Datopotamab deruxtecan, 1 mg" (permanent, eff. 2026; pre-2026 used J3490/C9399) · 1 unit = 1 mg |
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| NDC | 65597-801-01 (10) / 65597-0801-01 (11) — N4 qualifier; carton-level |
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| Vial | 100 mg lyophilized · reconstitute w/ 5 mL Sterile Water → 20 mg/mL |
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| Diluent | 5% Dextrose only for infusion bag (saline causes aggregation) |
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| Manufacturer | Daiichi Sankyo, Inc. (co-developed with AstraZeneca) |
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| Benefit | Medical (provider buy-and-bill); not specialty pharmacy |
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Dosing & infusion
- 6 mg/kg IV on Day 1 of every 21-day cycle
- Continue until disease progression or unacceptable toxicity
- First infusion: 90 min (96413 + 96415 × 1); observe ≥60 min after
- Subsequent: 30 min (96413 alone); observe ≥30 min after each
- ~17 cycles/yr = 17 infusions; year-1 ~$394K ASP+6% (75 kg)
- Premed: antiemetics (moderate emetogenic); consider corticosteroid for stomatitis prophylaxis; preservative-free ocular lubricant throughout course
Unit math by weight (6 mg/kg)
| Weight | Dose | Vials | JZ units | JW units |
|---|
| 50 kg | 300 mg | 3 | 300 | 0 (JZ only) |
| 60 kg | 360 mg | 4 | 360 | 40 |
| 70 kg | 420 mg | 5 | 420 | 80 |
| 75 kg | 450 mg | 5 | 450 | 50 |
| 80 kg | 480 mg | 5 | 480 | 20 |
| 90 kg | 540 mg | 6 | 540 | 60 |
| 100 kg | 600 mg | 6 | 600 | 0 (JZ only) |
Reconcile: JZ + JW units = vials × 100 mg
Administration & modifiers
| Code | When |
|---|
96413 | Chemo IV, first hour (every Datroway infusion) |
96415 | Chemo IV, addl hour — first dose only (90 min); omit subsequent (30 min) |
96365 | NOT appropriate — Datroway is cytotoxic chemo (DXd payload) |
JZ | Administered units (mg admin) |
JW | Wasted units (mg discarded) — separate line |
JZ + JW both required on most claims. Weight-based dosing + 100 mg vials = partial-vial waste is the rule. Audit recurring 96415 on subsequent cycles — should only be on first dose.
ICD-10 by indication
| Code | Indication |
|---|
C50.x1 / C50.x2 | Breast (R/L by quadrant) — HR+/HER2- mBC |
Z17.0 / Z17.1 | ER+ / PR+ status (breast) |
C34.xx | Lung — EGFR-mutated NSCLC; EGFR mutation type (ex19del / L858R) in chart |
C77-C79 | Secondary metastatic sites per disease distribution |
NSCLC indication is accelerated approval (Jun 23, 2025). Confirmatory data still maturing; payer policy stable but verify before billing C34.x.
ILD/Pneumonitis monitoring
- Class effect for deruxtecan ADCs — same payload as Enhertu
- Baseline: pulmonary history + chest imaging (CT preferred); spirometry/DLCO if indicated
- Monitor for new/worsening cough, dyspnea, fever each cycle
- Any-grade suspected ILD: hold dose; eval w/ imaging + pulm consult; corticosteroids per label
- Grade 2+ confirmed ILD: permanently discontinue
- Document baseline pulmonary status in chart for PA submissions and appeals
Payer requirements (May 2026)
| Payer | PA | Focus |
|---|
| UnitedHealthcare | Yes | Line of therapy strict; biomarker (receptor/EGFR); pulmonary baseline; Optum site-of-care UM |
| Aetna | Yes | NCCN-aligned; ILD monitoring plan for appeals; HOPD steering after C1 |
| BCBS / Anthem | Yes | NCCN-aligned; baseline pulmonary docs for deruxtecan class |
| Medicare | No | MAC LCDs; biomarker documentation |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $51.516 / mg · 4/1 – 6/30/2026 |
| 450 mg dose (75 kg) | $23,182.20 (450 × $51.516) |
| 600 mg dose (100 kg) | $30,909.60 (600 × $51.516) |
| Per cycle | 1 dose every 21 days |
| Annual (~17 cycles) | ~$394,000 (75 kg, before sequestration) |
Site of care
| Setting | POS | Notes |
|---|
| Physician office | 11 | Preferred for cycle 2+ (30 min fits cleanly) |
| Ambulatory infusion suite | 49 | Preferred |
| Hospital outpatient | 19/22 | Common for first dose (90 min + obs); UHC/Aetna disfavor C2+ |
| Patient home | 12 | Rare — ILD monitoring favors clinic |
Patient assistance — DATROWAY4U
- Phone: 1-855-DATRO4U (1-855-328-7648)
- Commercial copay: as little as $0 per infusion (DATROWAY Patient Savings Program)
- PAP: free Datroway for uninsured/underinsured (income criteria) via Daiichi Sankyo Access Central
- Foundations (Medicare): PAN, HealthWell, CancerCare, Good Days — verify open breast + NSCLC funds quarterly
- Web: datroway4u.com / datrowayhcp.com
TOP DENIALS — (1) PA: sequence-of-therapy not documented (prior endocrine + chemo for mBC; prior EGFR TKI + platinum for NSCLC). (2) Missing JW line on weight-based doses. (3) Baseline ILD/pneumonitis assessment missing from chart. (4) Wrong HCPCS (J9317/J9358 cross-confusion).
Pending SME review. Verify high-stakes claims against current FDA label and payer policies before submission.