Codes & NDC
| HCPCS | J9359 — "Inj, loncastuximab tesirine-lpyl, 0.075 mg" (permanent, eff. 1/1/2022) |
|---|
| NDC | 73063-110-01 (10) / 73063-0110-01 (11) — N4 qualifier |
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| Vial | 10 mg lyophilized single-dose — reconstitute 2.2 mL SWFI → 5 mg/mL |
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| Dilute | 0.9% NaCl 50–100 mL; use immediately or refrig ≤24 hr; do not freeze, swirl don't shake |
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| Storage | Refrig 2–8°C, protect from light |
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| Benefit | Medical (provider buy-and-bill); not specialty pharmacy |
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Dosing (load → reduce)
| Cycle | Dose | Day | Duration |
|---|
| C1 | 150 mcg/kg IV | D1 | 30 min |
| C2 | 150 mcg/kg IV | D1 | 30 min |
| C3+ | 75 mcg/kg IV | D1 | 30 min |
Cycle 3 dose is HALF of C1–2. Common denial: billing C3+ at 150 mcg/kg level. Audit cycle counter on every claim.
Premed — mandatory dex protocol
| Day | Dex dose | Route |
|---|
| Day −1 | 4 mg BID | PO or IV |
| Day 0 (infusion) | 4 mg BID | PO or IV |
| Day +1 | 4 mg BID | PO or IV |
#1 DENIAL DRIVER. Dex 4 mg BID × 3 days starting day before infusion is FDA-label mandated. Document start/stop dates each cycle. IV dex bills J1100 (1 mg/unit). PO dex not billed under medical benefit.
JW waste — C1–2 (150 mcg/kg, 10 mg vials)
| Wt | Dose | Units | Vials | JW |
|---|
| 50 kg | 7.5 mg | 100 | 1 | 34 |
| 60 kg | 9 mg | 120 | 1 | 14 |
| 70 kg | 10.5 mg | 140 | 2 | 127 |
| 80 kg | 12 mg | 160 | 2 | 107 |
| 90 kg | 13.5 mg | 180 | 2 | 87 |
| 100 kg | 15 mg | 200 | 2 | 67 |
JW waste — C3+ (75 mcg/kg)
| Wt | Dose | Units | Vials | JW |
|---|
| 50 kg | 3.75 mg | 50 | 1 | 84 |
| 70 kg | 5.25 mg | 70 | 1 | 64 |
| 90 kg | 6.75 mg | 90 | 1 | 44 |
| 100 kg | 7.5 mg | 100 | 1 | 34 |
Units = mg ÷ 0.075 (round UP for JW waste). One of JZ or JW required on every claim (CMS 7/1/2023).
Administration
| Code | When |
|---|
96413 | Chemo IV initial — every cycle, 30-min infusion |
96415 | NOT NEEDED — 30 min fits in 96413 window |
J1100 | Dex 1 mg/unit (if IV premed) |
96365 | NOT appropriate — Zynlonta is ADC w/ PBD payload |
ICD-10 — R/R DLBCL
| Code | For |
|---|
C83.30 | DLBCL, unspecified site (most common) |
C83.31–C83.39 | DLBCL by site (head/neck, intrathoracic, abdominal, axilla, inguinal, pelvic, spleen, multiple, extranodal) |
C85.8x | HGBCL "double-hit" / other NHL — per label inclusion |
Z51.11 | Encounter for antineoplastic chemo (secondary) |
C85.20 | PMBCL — off-label |
C85.9x | NHL unspecified — insufficient; need DLBCL pathology |
DLBCL R/R salvage landscape
| Drug | HCPCS | Class | Line |
|---|
| Zynlonta | J9359 | CD19 ADC (PBD) | R/R 3L+ mono |
| Polivy | J9309 | CD79b ADC (MMAE) | 1L combo / 3L+ combo |
| Columvi | J9286 | CD20×CD3 bispecific | R/R 3L+ mono |
| Epkinly | J9321 | CD20×CD3 bispecific (SC) | R/R 3L+ mono |
Zynlonta competes head-to-head with bispecifics in post-CAR-T / post-2L space. Operationally simpler than bispecifics (no CRS, no step-up) but stricter premed.
Payer requirements (May 2026)
| Payer | PA | Key criteria |
|---|
| UnitedHealthcare | Yes | DLBCL pathology + ≥2 prior systemic + CD19+ + dex premed plan |
| Aetna | Yes | FDA-labeled only; NCCN-aligned; treatment history |
| BCBS plans | Yes | NCCN B-cell + FDA label; CD19+ confirmation often requested |
| Cigna | Yes | FDA-labeled R/R DLBCL after 2+ prior systemic |
| Medicare LCDs | No (FFS); MA yes | FDA-labeled indication |
Top 3 PA elements: CD19+ pathology, ≥2 prior systemic line documentation, dex premed plan. Adults only.
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $221.493 / unit (per 0.075 mg, eff. 4/1 – 6/30/2026) |
| C1–2 dose 70 kg (140 units) | $31,009.02 |
| C3+ dose 70 kg (70 units) | $15,504.51 |
| JW C1–2 waste 70 kg (127 u) | ~$28,129.61 |
Site of care
| Setting | POS | Notes |
|---|
| HOPD (comprehensive cancer ctr) | 22 | Common |
| HOPD (off-campus PBD) | 19 | Common |
| Physician oncology office | 11 | OK w/ chemo infrastructure |
| Freestanding infusion suite | 49 | OK w/ ADC monitoring capability |
| Patient home | 12 | Not appropriate |
Patient assistance — ADC Therapeutics
- Phone: 1-855-690-0340 (ADC Therapeutics Patient Support, M–F 8 AM–8 PM ET)
- Commercial copay: Zynlonta Co-Pay Assistance Program (commercially-insured only)
- Patient Assistance Program: free product for uninsured/underinsured ≤500% FPL
- Foundations (Medicare): PAN, HealthWell, CancerCare, LLS Co-Pay
- Web: zynlontahcp.com/patient-support
TOP DENIALS: (1) dex premed not documented (3-day course), (2) CD19+ not confirmed in pathology, (3) cycle 3+ billed at C1 dose level, (4) <2 prior systemic lines documented, (5) JW waste line missing or fractional units rounded wrong.
NO Boxed Warning, but W&P include: edema/effusions (3rd-space fluid, PBD-payload driven), myelosuppression, serious infection, hepatotoxicity (LFT monitoring), cutaneous reactions, embryo-fetal toxicity. Adults only — no pediatric indication. Accelerated approval (LOTIS-2, Apr 2021); LOTIS-7 is the confirmatory trial.