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: Q2 2026

HCPCS

J9326

1 unit = 1 mg

Dose (80 kg)

152 units

152 mg = 1.9 mg/kg

Modifier

JZ + JW

Weight-based + 20/100 mg vials

Admin CPT

96413

Chemo IV (30 min + filter)

Medicare ASP+6%

$145.994

/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
NDC (100 mg)	`0074-1055-01` (10) / `00074-1055-01` (11) — N4 qualifier; carton-level, single-dose lyophilized vial
Reconstitution	20 mg vial: 1.1 mL SWFI · 100 mg vial: 5.2 mL SWFI → both yield 20 mg/mL
Diluent	0.9% Sodium Chloride for the IV bag; use 0.20 or 0.22 micron in-line filter (PES, PVDF, or polyamide)
Manufacturer	AbbVie Inc. (development codename Teliso-V / ABBV-399)
Benefit	Medical (provider buy-and-bill); not specialty pharmacy

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)	JZ 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: JZ + 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 + 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 (Q2 2026)

Field	Value
ASP + 6%	$145.994 / mg · 4/1 – 6/30/2026
152 mg dose (80 kg)	$22,191.09 (152 × $145.994)
190 mg dose (cap)	$27,738.86 (190 × $145.994)
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).

Pending SME review. Verify high-stakes claims against current FDA label and payer policies before submission.

Sources: FDA label (Emrelis, BLA 761384, approved 5/14/2025), CMS ASP Q2 2026, CMS HCPCS J9326, AbbVie Emrelis HCP + myAbbVie Assist 2026, UHC/Aetna/BCBS oncology policies, NCCN NSCLC, Roche VENTANA MET (SP44) RxDx Assay. carecostestimate.com/drugs/teliso-v