Epkinly (epcoritamab-bysp) — HCPCS J9321

CareCost Estimate · Billing Cheat Sheet

AbbVie / Genmab 4 mg/0.8 mL & 48 mg/0.8 mL single-dose vials SC injection (NOT IV) Reviewed: May 2, 2026 ASP: Q2 2026

Unit-basis trap — #1 J9321 biller error

J9321: 1 unit = 0.16 mg · 1 mg = 6.25 units · 48 mg = 300 units

Descriptor: "Injection, epcoritamab-bysp, 0.16 mg." The 48 mg full treatment dose bills as 300 units, NOT 48 units. Practices that bill "1 mg = 1 unit" by reflex (Lunsumio J9350, Columvi J9286) will under-bill by 252 units per dose — ~$14,343 lost reimbursement per administration. Validate billing software conversion before going live.

HCPCS unit

0.16 mg

= 1 unit (UNUSUAL)

48 mg dose

300 units

NOT 48 units

Route

NOT IV (vs Lunsumio/Columvi)

Admin CPT

96401

Chemo SC, non-hormonal

Medicare ASP+6%

$56.916

/unit · $17,074.80/48 mg

Codes & vials

HCPCS	`J9321` — "Inj, epcoritamab-bysp, 0.16 mg" (permanent)
NDC	Pull from AbbVie carton at billing time; N4 qualifier + ML UoM
Vials	4 mg/0.8 mL SDV (step-up) · 48 mg/0.8 mL SDV (treatment)
Manufacturer	AbbVie / Genmab (US: AbbVie commercializes)
Benefit	Medical (provider buy-and-bill)

Cycle frequency — weekly to q4wk taper

Phase	Schedule	Doses/cycle
C1 (step-up + first full)	D1: 0.16 mg · D8: 0.8 mg · D15: 48 mg · D22: 48 mg	4
C2–3 (weekly)	48 mg SC weekly (D1, 8, 15, 22)	4
C4–9 (q2wk)	48 mg SC every 2 weeks (D1, 15)	2
C10+ (q4wk, until prog)	48 mg SC every 4 weeks (D1)	1

Treatment continued until progression. NOT fixed-duration like Lunsumio (8–17 cycles) or Columvi (12 cycles).

Cycle 1 dose & units

Day	Dose	Units	Modifier
C1 D1	0.16 mg SC	1 unit	JW (24 units waste from 4 mg vial)
C1 D8	0.8 mg SC	5 units	JW (20 units waste from 4 mg vial)
C1 D15	48 mg SC (intermediate)	300 units	JZ
C1 D22	48 mg SC (first full)	300 units	JZ
C1 total: 606 units · ~$34,491 (Q2 2026 ASP+6%)

Premedication (all C1 doses)

30–120 min before each Cycle 1 dose (D1, D8, D15, D22):

Corticosteroid: prednisolone 100 mg PO/IV (or equivalent)
Antihistamine: diphenhydramine 50 mg PO/IV
Antipyretic: acetaminophen 650–1000 mg PO

May modify or discontinue from C2 if no Grade 2+ CRS.

Administration & modifiers

Code	When
`96401`	Chemo admin SC, non-hormonal — primary code
`96372`	Therapeutic SC injection — some payers accept; pays less
`96413/96415`	NOT applicable — IV codes for Lunsumio/Columvi
JZ on full 48 mg doses · JW on C1 D1 (24 units waste) and C1 D8 (20 units waste) step-up doses

ICD-10 — DLBCL family

Code	For
`C83.30–.39`	DLBCL (incl. NOS, arising from indolent lymphoma)
`C83.70–.79`	Burkitt — for high-grade B-cell lymphoma
`C83.80–.89`	Other non-follicular — high-grade B-cell, verify histology
`C85.20–.29`	Mediastinal LBCL — NOT labeled; verify per-payer

ICD-10 — Follicular lymphoma family

Code	For
`C82.00–.09`	FL grade 1
`C82.10–.19`	FL grade 2
`C82.20–.29`	FL grade 3
`C82.30–.49`	FL grade 3a / 3b
`C82.50–.69`	Diffuse follicle / cutaneous variants

Both DLBCL and FL covered. DLBCL: full approval May 2023. FL: accelerated approval June 2024. Both require ≥2 prior lines of systemic therapy.

IV vs SC bispecific landscape

Drug	HCPCS	Unit	Route	Indication
Epkinly	`J9321`	0.16 mg	SC	DLBCL + FL
Lunsumio	`J9350`	1 mg	IV	FL
Columvi	`J9286`	1 mg	IV	DLBCL
BCMA bispecifics (MM, REMS): Tecvayli (J9380, SC), Elrexfio (SC), Talvey (SC) — ALL use 1 mg = 1 unit, NOT 0.16 mg

Payer requirements (May 2026)

Payer	PA	Step / Documentation
UnitedHealthcare	Yes	DLBCL/FL Dx + IHC + ≥2 prior lines (CAR-T history typical for DLBCL)
Aetna	Yes	Site-of-care UM for oncology bispecifics; line of therapy ≥3
Cigna / eviCore	Yes	Aligned with FDA label + NCCN B-Cell Lymphoma Guidelines
BCBS plans	Yes	Plan-specific; most have site-of-care steering
Medicare Part B	No	MAC LCDs cover for label indication; no CMS site-of-care UM

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6% per unit (0.16 mg)	$56.916
ASP + 6% per mg (informational)	$355.73
0.16 mg priming dose (1 unit)	$56.92
0.8 mg step-up (5 units)	$284.58
48 mg full dose (300 units)	$17,074.80
Cycle 1 total (606 units)	~$34,491
Annual ongoing (C10+ q4wk, 13 doses)	~$221,972/yr

Site of care

Setting	POS	Notes
HOPD / extended OP (24-hr obs)	22	Common for C1 D15 first 48 mg dose
Outpatient infusion suite	22 / 11	C1 step-up encounters
Physician oncology office	11	OK for C2+ SC injections (CRS-capable)
Ambulatory infusion center	49	OK for C2+ SC injections
Patient home	12	Not appropriate — needs CRS-capable site

Patient assistance — AbbVie

Phone: 1-844-EPKINLY (1-844-375-4659)
myAbbVie Assist (PAP): free product for uninsured/underinsured
Co-Pay Card: $0 commercial copay (excludes Medicare/Medicaid/federal)
Foundations (Medicare): PAN, HealthWell, CancerCare, LLS — verify open lymphoma funds
Web: epkinly.com / abbviepatientassistancefoundation.org

BOXED WARNING — CRS + ICANS: Cytokine Release Syndrome (~51% any-grade, ~2.5% Gr 3+) and ICANS (~6% any-grade, <1% Gr 3+). Tocilizumab (Actemra) on hand. 24-hr observation post C1 D15 first 48 mg dose. No formal REMS, but site CRS/ICANS protocol mandatory.

Sources: AbbVie Epkinly PI (BLA 761324; DLBCL May 2023, FL Jun 2024), CMS ASP Q2 2026, NCCN B-Cell Lymphomas, UHC/Aetna/Cigna oncology policies, AbbVie Patient Assistance Foundation. Pending SME review. carecostestimate.com/drugs/epkinly