Entyvio (vedolizumab) — HCPCS J3380

CareCost Estimate · Billing Cheat Sheet

Takeda Pharmaceuticals U.S.A. 300 mg single-dose vial (lyophilized) IV induction + q8wk maintenance Reviewed: May 2, 2026 ASP: Q2 2026

HCPCS

J3380

1 mg = 1 unit

Dose

300 units

300 mg q8wk · 1 vial

Modifier

Whole-vial; verify SDC list

Admin CPT

96365

Therapeutic IV (~30 min) — non-chemo

Medicare ASP+6%

$20.98

/mg · $6,294.00/dose

Codes & NDC

HCPCS (IV)	`J3380` — "Injection, vedolizumab, 1 mg" (permanent)
HCPCS (SC)	`J3590` unclassified biologic on medical benefit; usually pharmacy benefit
IV NDC	`64764-300-20` (10) / `64764-0300-20` (11) — N4 qualifier
SC NDCs	Pen `64764-108-21` · PFS `64764-107-11` (108 mg/0.68 mL)
Vial	300 mg lyophilized SDV; reconstitute to 60 mg/mL, dilute in 250 mL NaCl/LR
Benefit	Medical (provider buy-and-bill) for IV; pharmacy benefit dominant for SC pen

Dosing

IV induction: 300 mg IV at Week 0, Week 2, Week 6 (UC and CD)
IV maintenance: 300 mg IV every 8 weeks starting Week 14
Infusion ~30 minutes; 1 vial per dose; no loading dose beyond Wk 0/2/6
Dose intensification: q4wk maintenance permitted by some payers (PA req.)
SC maintenance: 108 mg SC q2wk after ≥2 IV induction doses (replaces next IV)
Year-1: 9 doses (3 induction + 6 maintenance) = 2,700 units
Steady-state: ~6.5 doses/yr = ~1,950 units/yr

Administration & modifiers

Code	When
`96365`	Therapeutic IV, ~30 min (primary) — non-chemo
`96366`	Rarely needed (infusion fits within first hour)
`96413`/`96415`	NOT appropriate — vedolizumab is non-chemo (legacy mapping bug)
JZ: 300 mg dose uses one full vial; expected modifier when J3380 is on CMS SDC list. JW rare (no routine waste).

Known coding error: some legacy systems map J3380 to chemo admin (96413/96415). Use 96365 — 96413 will trigger payer audits and recoupment.

SC Entyvio Pen — J3590, not J3380

108 mg SC q2wk maintenance after ≥2 IV induction doses
Medical benefit: J3590 + SC NDC (manual pricing)
Most plans route SC through pharmacy benefit (specialty pharmacy)
BCBSM (Mar 2024) removed PA on SC under medical benefit

Don't bill SC under J3380. J3380 pricing is tied to the IV product — SC NDC under J3380 = denial or overpayment.

ICD-10 — Ulcerative Colitis

Code	For
`K51.00 / K51.01x`	Ulcerative pancolitis
`K51.20 / K51.21x`	Ulcerative proctitis
`K51.30 / K51.31x`	Rectosigmoiditis
`K51.50 / K51.51x`	Left-sided colitis
`K51.80 / K51.81x`	Other UC
`K51.90 / K51.91x`	UC unspecified

ICD-10 — Crohn's Disease

Code	For
`K50.00 / K50.01x`	Crohn's small intestine
`K50.10 / K50.11x`	Crohn's large intestine
`K50.80 / K50.81x`	Crohn's both
`K50.90 / K50.91x`	Crohn's unspecified

Specify subcodes (.011 bleeding, .012 obstruction, .014 abscess) — supports medical-necessity. Avoid defaulting to K50.90 / K51.90.

Payer requirements (May 2026)

Payer	PA	Step / Site of care
UnitedHealthcare	Yes	TNFi step typical; HOPD steerage active
Aetna (CPB 0890)	Yes	TNFi step; site-of-care UM
Anthem / Carelon	Yes	UC may be first-line w/ TNFi contraindication
BCBS regional / BCBSM	Yes	BCBSM removed PA on SC under medical (Mar 2024)

TNFi step therapy is the dominant pattern. Document failure/intolerance of Humira, Remicade, or biosimilar before submission.

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6%	$20.98 / mg (effective 4/1 – 6/30/2026)
300 mg dose	$6,294.00 (300 × $20.98)
Year-1 (9 doses)	~$56,646
Steady-state (~6.5 doses/yr)	~$40,911/year

Site of care

Setting	POS	Notes
Physician office	11	~30-min infusion fits cleanly
Ambulatory infusion suite	49	Common
Hospital outpatient	19/22	UHC/Anthem disfavor — redirection at re-auth
Patient home (SC)	12	SC pen self-administered

Patient assistance — EntyvioConnect

Phone: 1-800-352-2236 (Takeda EntyvioConnect, M–F)
Fax: 844-595-6272
Commercial copay: as low as $5 for eligible patients
PAP: free product for eligible uninsured/underinsured
Foundation referral (Medicare/Medicaid) for copay help

NO Boxed Warning — gut-selective α4β7 mechanism avoids PML risk (unlike Tysabri). Warnings & Precautions: infusion reactions, infections, PML (rare), hepatotoxicity. No REMS required.

Sources: Takeda Entyvio FDA label (2024), CMS HCPCS J3380, CMS ASP Q2 2026 file, UHC/Aetna CPB 0890/Carelon/BCBS vedolizumab policies, EntyvioConnect, AAPC. carecostestimate.com/drugs/entyvio