Imjudo (tremelimumab-actl) — HCPCS J9347

CareCost Estimate · Billing Cheat Sheet

AstraZeneca 25 mg/1.25 mL & 300 mg/15 mL single-dose vials (20 mg/mL) IV infusion · ~60 min · Anti-CTLA-4 mAb · Combo-only with Imfinzi Reviewed: May 22, 2026 ASP: Q2 2026

HCPCS

J9347

1 mg = 1 unit

HCC STRIDE

300 units

Single 300 mg priming Day 1 only

Modifier

JZ / JW

JZ for SDV zero-waste (default)

Admin CPT

96413

+96417 sequenced w/ Imfinzi

Medicare ASP+6%

$143.228

/mg · $42,968.40 / 300 mg STRIDE

COMBO-ONLY DRUG. J9347 must always appear on the claim alongside J9173 (Imfinzi) on the same date of service. Bare J9347 lines = #1 denial. No labeled monotherapy use.

Codes & NDC

HCPCS	`J9347` — "Inj., tremelimumab-actl, 1 mg" (permanent 1/1/24)
NDC (25 mg)	`00310-1320-25` — 25 mg / 1.25 mL single-dose vial; N4 qualifier; POSEIDON 75 mg uses 3 vials
NDC (300 mg)	`00310-1320-30` — 300 mg / 15 mL single-dose vial; HCC STRIDE 300 mg = 1 vial, zero waste
Combo partner	Imfinzi (durvalumab, `J9173`, 10 mg/unit) — required on every J9347 claim. See carecostestimate.com/drugs/imfinzi.
Class	Anti-CTLA-4 mAb (the other CTLA-4: Yervoy / ipilimumab, J9228, BMS — different drug, not interchangeable)

Dosing — STRIDE vs POSEIDON

Indication / Trial	Regimen
Unresectable HCC (HIMALAYA STRIDE)	300 mg IV single dose Day 1 → then Imfinzi 1,500 mg q4w only. No further Imjudo.
Metastatic NSCLC (POSEIDON)	75 mg IV q3w × 4 doses with chemo + Imfinzi cycles 1-4, plus 1 additional dose at week 16 (5 total). Patients <30 kg: 1 mg/kg.
Pediatric	Not approved — safety/efficacy not established <18 yr

STRIDE Day 1 unit math: J9347 = 1 mg/unit (300 mg = 300 units); J9173 = 10 mg/unit (1,500 mg = 150 units). Easy trap.

Administration & modifiers

Code	When
`96413`	Chemo IV admin, up to 1 hr — initial drug (typically Imjudo first per STRIDE/POSEIDON protocol)
`96415`	Each additional hr (uncommon for the Imjudo 60-min infusion alone)
`96417`	Each sequential drug (Imfinzi after Imjudo, chemo after Imfinzi) — the key combo admin code
`96365`	Not appropriate — ICIs bill chemo admin per AMA
`JZ`	Required: HCC 300 mg (1 vial, no waste) and POSEIDON 75 mg (3 × 25 mg vials, no waste)
`JW`	Only if any partial-vial waste occurs — line-itemed separately

ICD-10 by indication

Code	For
`C22.0`	HCC (hepatocellular) — HIMALAYA STRIDE; pair with Child-Pugh A docs
`C34.x`	NSCLC (lobe-specific 4th char; both squamous + non-squamous) — POSEIDON; pair with EGFR/ALK status
`C78.7`	Secondary liver (metastatic HCC)
`C78.0` / `C79.31` / `C79.51`	Common NSCLC mets (lung, brain, bone)

CTLA-4 class — Imjudo vs Yervoy

Drug	HCPCS	Mfr	Indications
Imjudo	`J9347`	AstraZeneca	HCC + NSCLC only, combo-only with Imfinzi
Yervoy	`J9228`	BMS	Melanoma mono + multi-tumor Opdivo combos

Different molecules. Not interchangeable. Each has its own indications, NCCN positioning, NDC, and ASP.

Top denials (May 2026)

Reason	Fix
J9347 without paired J9173	Resubmit with both drugs on same DOS; FDA label permits no mono use
PA missing HCC histology / Child-Pugh A	Submit path report + Child-Pugh score + unresectability imaging
PA missing EGFR/ALK status (POSEIDON)	Submit molecular pathology confirming wildtype/negative
Wrong unit math (300 mg as 30 units)	J9347 = 1 mg/unit. 300 mg = 300 units, not 30.
STRIDE "cycle 2 Imjudo" scheduled	STRIDE = single Day 1 dose only. Cancel. Re-verify regimen.
irAE management docs insufficient (renewal)	Submit pre-cycle labs (LFTs, TSH, cortisol, glucose) + symptom screen

Medicare reimbursement (Q2 2026)

Field	Value
ASP + 6%	$143.228 / mg (4/1 – 6/30/2026)
HCC STRIDE (300 mg, one-time)	$42,968.40 (300 units)
POSEIDON per dose (75 mg)	$10,742.10 (75 units)
POSEIDON full course (5 × 75 mg)	$53,710.50 (375 units)

Patient assistance — AZ Access 360

Phone: 1-844-275-2360 (single contact for Imjudo + Imfinzi)
Imjudo Co-pay Program: commercial $0 first dose; ongoing copay assistance to annual cap (no Medicare / Medicaid / federal)
AZ Patient Assistance Foundation (AZ&Me): free drug for uninsured/underinsured
Medicare patient foundations: PAN, HealthWell, CancerCare, PAF Co-Pay Relief — check open liver/lung funds quarterly
Web: myaccess360.com / azandmeapp.com

irAE WARNINGS (Boxed analog): immune-mediated colitis/diarrhea, hepatitis, endocrinopathies (adrenal insufficiency, hypophysitis, hypothyroidism, T1DM), pneumonitis, nephritis, dermatologic (SJS/TEN/DRESS), infusion reactions; rare myocarditis/encephalitis/GBS. CTLA-4 toxicity is materially heavier than PD-(L)1 mono — baseline + pre-cycle labs (LFTs, TSH, AM cortisol, ACTH, glucose) and steroid algorithm critical.

Sources: FDA label (BLA 761270, Oct 21, 2022 HIMALAYA HCC + Nov 10, 2022 POSEIDON NSCLC), CMS ASP Q2 2026, NCCN (Hepatobiliary, NSCLC), AstraZeneca Access 360, UHC/Aetna oncology policies, HIMALAYA NEJM + POSEIDON JCO publications. carecostestimate.com/drugs/imjudo