Emrelis (telisotuzumab vedotin-tllv) — HCPCS J9326
CareCost Estimate · Billing Cheat Sheet
AbbVie Inc.
20 mg + 100 mg lyophilized vials
1.9 mg/kg IV q2w (max 190 mg)
Reviewed: May 21, 2026
ASP: Q3 2026
Dose (80 kg)
152 units
152 mg = 1.9 mg/kg
Modifier
JZ or JW
Weight-based + 20/100 mg vials
Admin CPT
96413
Chemo IV (30 min + filter)
Medicare ASP+6%
$146.060
/mg · $22,191/152 mg
DO NOT CONFUSE c-Met OVEREXPRESSION (J9326) WITH c-MET EXON 14 SKIPPING (Tabrecta / Tepmetko).
Emrelis = IHC SP44 ≥50% strong (3+). Tabrecta/Tepmetko = NGS exon 14 mutation. Two different biomarkers, two different drugs. PA for J9326 requires SP44 IHC, not the NGS mutation report.
Codes & NDC
| HCPCS | J9326 — "Telisotuzumab vedotin-tllv, 1 mg" (permanent) · 1 unit = 1 mg |
|---|
| NDC (20 mg) | 0074-1044-01 (10) / 00074-1044-01 (11) — N4 qualifier; carton-level, single-dose lyophilized vial |
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| NDC (100 mg) | 0074-1055-01 (10) / 00074-1055-01 (11) — N4 qualifier; carton-level, single-dose lyophilized vial |
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| Reconstitution | 20 mg vial: 1.1 mL SWFI · 100 mg vial: 5.2 mL SWFI → both yield 20 mg/mL |
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| Diluent | 0.9% Sodium Chloride for the IV bag; use 0.20 or 0.22 micron in-line filter (PES, PVDF, or polyamide) |
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| Manufacturer | AbbVie Inc. (development codename Teliso-V / ABBV-399) |
|---|
| Benefit | Medical (provider buy-and-bill); not specialty pharmacy |
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Dosing & infusion
- 1.9 mg/kg IV every 2 weeks, max 190 mg per dose
- Day 1 of every 14-day cycle; continue until progression or unacceptable toxicity
- Infusion: 30 min through 0.20 or 0.22 micron in-line filter (PES/PVDF/polyamide)
- No IV push or bolus
- ~26 doses/year of continuous therapy
- No required premed regimen on label; antiemetic per institution standard for ADCs
Unit math by weight (1.9 mg/kg, 190 mg cap)
| Weight | Dose | Vials (efficient) | Administered units | JW units |
|---|
| 50 kg | 95 mg | 1 × 100 mg | 95 | 5 |
| 60 kg | 114 mg | 1 × 100 mg + 1 × 20 mg | 114 | 6 |
| 70 kg | 133 mg | 1 × 100 mg + 2 × 20 mg | 133 | 7 |
| 80 kg | 152 mg | 1 × 100 mg + 3 × 20 mg | 152 | 8 |
| 90 kg | 171 mg | 1 × 100 mg + 4 × 20 mg | 171 | 9 |
| 100 kg | 190 mg (cap) | 2 × 100 mg | 190 | 10 |
| ≥110 kg | 190 mg (cap) | 2 × 100 mg | 190 | 10 |
Reconcile: Administered + JW units = mg drawn from vials · Cap at 190 mg regardless of weight-based calc
Administration & modifiers
| Code | When |
|---|
96413 | Chemo IV, first hour (every Emrelis infusion; 30 min fits) |
96415 | Not needed — routine 30 min infusion under 1 hr |
96365 | NOT appropriate — Emrelis is cytotoxic chemo (MMAE / vedotin payload) |
JZ | Administered units (mg admin) |
JW | Wasted units (mg discarded) — separate line |
JZ or JW both required on virtually every adult claim. Weight-based dose + 20/100 mg vials = partial-vial waste is the rule.
c-Met IHC biomarker (SP44) — PA gating
| Element | Value |
|---|
| Test | VENTANA MET (SP44) RxDx Assay (Roche Diagnostics) |
| Method | IHC on FFPE tumor tissue; SP44 rabbit monoclonal clone |
| Eligibility threshold | ≥50% tumor cells with strong (3+) membrane staining ("HIGH" c-Met overexpression) |
| Histology | Non-squamous NSCLC only (squamous excluded) |
| Pathology CPT | 88341 / 88342 — billed by lab, NOT by infusion site |
Order SP44 IHC BEFORE submitting Emrelis PA. Generic "c-Met positive" or "2+ staining" results will be denied.
ICD-10 by indication
| Code | Indication |
|---|
C34.x | Non-squamous NSCLC by site/laterality (e.g., C34.10/11/12 upper lobe; C34.30/31/32 lower lobe) |
C79.31 | Secondary malignant neoplasm of brain (NSCLC w/ brain mets) |
C79.51 | Secondary malignant neoplasm of bone |
C78.x | Secondary neoplasms (liver C78.7; mediastinum C78.1; pleura C78.2; contralateral lung C78.0x) |
Z51.11 | Encounter for antineoplastic chemotherapy (pair on every admin claim line) |
Squamous NSCLC is NOT a labeled indication; verify non-squamous histology in path report before billing.
Payer requirements (May 2026)
| Payer | PA | Focus |
|---|
| UnitedHealthcare | Yes | SP44 ≥50% 3+; non-squamous; prior platinum + PD-(L)1; Optum site-of-care UM |
| Aetna | Yes | NCCN-aligned; SP44 IHC; prior platinum + IO documented |
| BCBS / Anthem | Yes | SP44 IHC; some plans request c-MET exon 14 status attestation |
| Medicare | MAC LCDs | FDA label + NCCN; histology + biomarker documentation |
Medicare reimbursement (Q3 2026)
| Field | Value |
|---|
| ASP + 6% | $146.060 / mg · 4/1 – 6/30/2026 |
| 152 mg dose (80 kg) | $22,191.09 (152 × $146.060) |
| 190 mg dose (cap) | $27,738.86 (190 × $146.060) |
| Per cycle | 1 dose every 14 days (~26/yr) |
| Annual (80 kg) | ~$576,968 (before sequestration / JW) |
| Next update | July 1, 2026 (Q3 2026) |
Site of care
| Setting | POS | Notes |
|---|
| Physician office | 11 | Preferred after cycle 1–2 (30 min fits cleanly) |
| Ambulatory infusion suite | 49 | Preferred — filter setup + monitoring |
| Hospital outpatient | 19/22 | Common for cycle 1; UHC/Aetna steer away thereafter |
| Patient home | 12 | Not typical — filter + ADC monitoring favors clinic |
Patient assistance — AbbVie
- Emrelis Support Services: 1-844-900-2228 · emrelishcp.com (BI, PA, appeals, commercial copay)
- Patient Savings Program: commercial copay as low as $0 (excludes Medicare/Medicaid/federal)
- myAbbVie Assist (PAP): 1-800-222-6885 · fax 1-866-250-2803 · pap.my.site.com — free Emrelis for uninsured/underinsured meeting income criteria
- Foundations (Medicare): PAN, HealthWell, CancerCare, Good Days — verify open lung cancer funds quarterly
- Web: emrelis.com (patient) / emrelishcp.com (HCP)
TOP DENIALS — (1) SP44 IHC threshold not documented (need explicit ≥50% strong 3+, not "c-Met positive"). (2) Missing JW line on weight-based doses. (3) c-MET exon 14 NGS report submitted instead of SP44 IHC (wrong biomarker for J9326). (4) Squamous histology submitted (not a labeled indication). (5) Dose > 190 mg cap (must cap regardless of weight).
Reviewed by Erin Rose, CareCost Estimate founder. Every figure triangulated against FDA labeling, CMS ASP files & payer policy — see
methodology.