Imjudo (tremelimumab-actl) — HCPCS J9347

Dosing by indication — HIMALAYA STRIDE and POSEIDON FDA label BLA 761289

Imjudo has two FDA-approved indications. The dose math is regimen-specific — 300 mg as a one-time priming dose in HCC vs five 75 mg doses in NSCLC. Verify the regimen against the encounter note before generating the claim.

Imjudo (tremelimumab-actl) is AstraZeneca's anti-CTLA-4 monoclonal antibody, approved in October-November 2022 for two combination regimens: hepatocellular carcinoma (HCC, HIMALAYA trial) and metastatic non-small cell lung cancer (NSCLC, POSEIDON trial). In both cases, Imjudo is paired with Imfinzi (durvalumab) and the regimens are not interchangeable — the HCC STRIDE regimen uses a single 300 mg priming dose while the NSCLC POSEIDON regimen uses five 75 mg doses. Imjudo is never given as monotherapy.

Worked example — HCC HIMALAYA STRIDE Day 1 (one-time priming)

Worked example — NSCLC POSEIDON full Imjudo course (5 doses)

Imfinzi combination billing — same-day sequencing AZ Access 360 verified May 2026

Both drugs are billed on separate claim lines with separate HCPCS, NDC, modifier, and units. CPT admin codes pair an initial 96413 with sequential 96417 for the second drug.

CTLA-4 inhibitor class comparison Reviewed May 2026

Imjudo and Yervoy are the only two FDA-approved CTLA-4 inhibitors. They are not interchangeable.

Anti-PD-(L)1 reference (for combo context)

NDC reference FDA NDC Directory verified May 2026

Administration codes CPT verified May 2026

Imjudo is billed as chemotherapy administration despite being immunotherapy (anti-CTLA-4 mAb) — consistent with all other immune checkpoint inhibitors.

Modifiers — JZ / JW with worked examples CMS verified May 2026

JZ — required when zero discard (the HCC STRIDE default)

Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The HCC HIMALAYA 300 mg STRIDE priming dose uses exactly one 300 mg single-dose vial — JZ applies to every HCC STRIDE Imjudo claim (zero waste). Same logic for the POSEIDON 75 mg dose if built from three 25 mg single-dose vials with no waste.

JW — report the discarded portion when any vial waste occurs

JW reports the discarded portion of a single-dose vial. For Imjudo, JW use is uncommon because both approved doses (300 mg HCC; 75 mg NSCLC) are designed to use whole vials with zero waste when the standard vial strengths are stocked. JW would apply only if a site stocked only the 300 mg vial and drew a 75 mg POSEIDON dose from it (225 mg wasted) — that practice is inefficient and uncommon, but the waste must be reported on a separate JW claim line if it occurs.

HCC STRIDE single-dose loading — worked JW/JZ example

NSCLC POSEIDON weight-based vs flat dose — worked example

Modifier 25 — same-day E/M

Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the infusion. Routine pre-infusion clinical assessment is bundled. Day 1 of STRIDE often warrants a significant E/M (treatment kickoff visit, irAE counseling, baseline labs review) — document the work and append modifier 25 if it meets the threshold.

340B modifiers (JG, TB)

For 340B-acquired Imjudo, follow your MAC's current 340B modifier policy. AstraZeneca Access 360 does not provide 340B-specific instructions; defer to your MAC's published guidance.

ICD-10-CM by indication FY2026 verified May 2026

Two indications. Use the most specific code supported by the encounter documentation. PA submissions require histology, staging, line-of-therapy, and combo-partner documentation.

Site of care & place of service Verified May 2026

UnitedHealthcare, Aetna, and most major BCBS plans run site-of-care UM for immune checkpoint inhibitors. Aetna CPB steers ICIs out of HOPD after the first 3 months unless on active chemo combo or active toxicity management. For Imjudo specifically, the dominant clinical context is the first 12 weeks of treatment (Day 1 STRIDE for HCC, or cycles 1-4 q3w combo for POSEIDON) — this period is generally allowed in HOPD due to the chemo concurrency or irAE-monitoring intensity.

Claim form field mapping AZ Access 360 Apr 2026

From the AstraZeneca Access 360 Imjudo coding guide.

HIMALAYA STRIDE Day 1 — CMS-1500 example

Payer policy snapshot Reviewed May 2026

All major payers require prior authorization for Imjudo and indication-specific clinical documentation. Get histology, staging, and biomarker / Child-Pugh notes packaged with the PA before submission.

Biomarker testing

Imjudo does not require a PD-L1 biomarker test for either FDA-approved indication. PA submissions are gated on histology (HCC), staging (HIMALAYA: unresectable; POSEIDON: 1L metastatic), prior therapy history, and combo-partner availability. For POSEIDON, document EGFR and ALK status (a negative result supports the IO+chemo combo selection; a positive result would steer to a targeted therapy first).

Step therapy

Step therapy from alternative regimens (e.g., Yervoy+Opdivo in HCC, atezolizumab+bevacizumab in HCC, Keytruda+chemo in NSCLC) is plan-dependent. NCCN guidelines list HIMALAYA STRIDE and POSEIDON as Category 1 / preferred options alongside the alternatives, so step-therapy denials are appealable on NCCN grounds in most cases. Document NCCN reference number in the appeal letter.

Medicare reimbursement CMS Q2 2026 (live)

Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.

Coverage

No NCD specific to tremelimumab-actl. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J9347 for FDA-approved on-label combo indications (HIMALAYA HCC; POSEIDON metastatic NSCLC) with appropriate ICD-10 and clinical documentation, when paired with J9173 on the same date of service.

Code history

• Pre-2024: billed under unclassified J3490 (or transitional C9399 in HOPD) following October 2022 FDA approval, with manufacturer NDC documentation
• January 1, 2024: J9347 — permanent code, "Injection, tremelimumab-actl, 1 mg"

Patient assistance — AstraZeneca Access 360 AZ verified May 2026

• AstraZeneca Access 360: 1-844-275-2360 / myaccess360.com — benefits investigation, prior authorization assistance, appeal support, claims help. Single point of contact for both Imjudo and Imfinzi (handled together for STRIDE / POSEIDON patients).
• Imjudo Co-pay Program: commercial copay support for eligible commercially-insured patients — $0 first dose assistance; ongoing copay assistance up to program annual cap (excludes Medicare, Medicaid, federal program patients per Anti-Kickback Statute). Verify current limits via AZ Access 360.
• AstraZeneca Patient Assistance Foundation (AZ&Me Prescription Savings): free product for uninsured / underinsured patients meeting income requirements (administered through 501(c)(3)) — azandmeapp.com
• Foundations for Medicare patients: refer to PAN Foundation, HealthWell Foundation, CancerCare, Patient Advocate Foundation Co-Pay Relief — verify open oncology funds quarterly (liver, lung, hepatobiliary)

Immune-mediated adverse reactions (irAEs) FDA W&P verified May 2026

Imjudo has no formal Boxed Warning, but the FDA W&P irAE profile should be treated as a Boxed analog operationally — CTLA-4 toxicity is materially heavier than PD-(L)1 monotherapy.

HIMALAYA STRIDE — CTLA-4-driven endocrine + colitis profile

The STRIDE regimen front-loads the CTLA-4 toxicity on Day 1 (single 300 mg priming dose). Expect higher rates of immune-mediated colitis, hepatitis, and endocrine events than with Imfinzi monotherapy. Most events occur within 12 weeks of the priming dose. Baseline and pre-each-cycle (Imfinzi cycles) workup: TSH/free T4, AM cortisol, ACTH, LFTs, glucose, basic chemistry. Document baseline values and any symptom-driven workup in the chart for both clinical and audit-defensibility purposes.

POSEIDON — combined CTLA-4 + PD-L1 + chemo toxicity

POSEIDON layers Imjudo CTLA-4 toxicity on top of Imfinzi PD-L1 toxicity and platinum doublet chemo toxicity for 4 cycles plus a 5th Imjudo dose at week 16. Hospitalization rates for grade 3+ irAEs and chemo-related toxicity are higher than with chemo + Imfinzi alone. Pre-cycle labs are essential. Steroid escalation per label (prednisone 1–2 mg/kg/day) for grade 2+ irAEs, permanent discontinuation for most grade 3-4 events.

Practical billing implication

irAE workup is separately billable: relevant E/M with modifier 25 if same-day as infusion; chest CT (CPT 71250 / 71260 with contrast) for pneumonitis; LFTs, TSH, cortisol, ACTH, glucose panels per encounter documentation. ICD-10: T80.52XA (anaphylactic reaction), T88.7XXA (unspecified adverse effect of drug), or specific irAE diagnosis codes (e.g., J70.2 acute drug pneumonitis, K52.81 eosinophilic colitis, K71.x drug-induced hepatitis, E03.9 hypothyroidism, E27.49 primary adrenocortical insufficiency, E23.0 hypopituitarism). Document irAE attribution explicitly in the chart for both clinical and audit-defensibility purposes, and for any subsequent PA renewals.

Common denials & how to fix them

Frequently asked questions

What is the HCPCS code for Imjudo?

Imjudo (tremelimumab-actl) is billed under HCPCS J9347 — "Injection, tremelimumab-actl, 1 mg." Each milligram equals one billable unit. The HCC HIMALAYA STRIDE regimen uses a single 300 mg priming dose on Day 1 (billed as 300 units of J9347), then the patient continues on Imfinzi (durvalumab, J9173) maintenance only. The NSCLC POSEIDON regimen uses 75 mg q3w for 5 doses. J9347 is a permanent code effective January 1, 2024 — pre-2024 claims used unclassified J3490 with manufacturer NDC documentation.

Imjudo vs Yervoy — when to choose?

Both are anti-CTLA-4 monoclonal antibodies but they are different molecules from different manufacturers with different indications and dosing. Yervoy (ipilimumab, J9228, Bristol Myers Squibb) is approved in melanoma monotherapy and in dual-checkpoint combos with Opdivo across multiple tumors. Imjudo (tremelimumab-actl, J9347, AstraZeneca) is approved only as a combo with Imfinzi — HCC HIMALAYA (single 300 mg priming dose) and metastatic NSCLC POSEIDON (75 mg q3w × 5 with Imfinzi + platinum chemo). They are not interchangeable: each has indication-specific FDA labeling, NCCN positioning, and its own HCPCS, NDC, and ASP.

How do I bill the STRIDE regimen for HCC?

STRIDE (Single Tremelimumab Regular-Interval Durvalumab) is the HIMALAYA HCC regimen. On Day 1 of cycle 1, bill BOTH drugs on separate claim lines: J9347 (Imjudo) 300 units + JZ (single 300 mg vial, zero waste) AND J9173 (Imfinzi) 150 units + JZ (1,500 mg in three 500 mg vials, zero waste). Use 96413 for the initial drug infusion and 96417 for the second sequential drug infusion. From Day 29 forward, the patient continues on Imfinzi 1,500 mg q4w only — no further Imjudo billing for this regimen.

Can Imjudo be billed as monotherapy?

No. Imjudo is FDA-approved only in combination with Imfinzi (durvalumab) — HCC HIMALAYA and metastatic NSCLC POSEIDON. A claim for J9347 without a paired J9173 line on the same date of service will be flagged by all major commercial payers and by Medicare LCDs. There is no labeled monotherapy use and NCCN guidelines do not list Imjudo as a monotherapy option.

Single dose vs multi-cycle Imjudo?

It depends on the indication. HIMALAYA HCC STRIDE = a single 300 mg priming dose on Day 1 only; the patient then continues on Imfinzi 1,500 mg q4w maintenance with no further Imjudo. POSEIDON metastatic NSCLC = five 75 mg doses q3w (cycles 1-4 with chemo + Imfinzi, plus a 5th dose at week 16). Reflexively scheduling "cycle 2 Imjudo" for a HIMALAYA patient on Day 22 will produce a denial — verify the regimen identification in the encounter note.

NSCLC POSEIDON combo billing?

On each POSEIDON cycle 1-4, bill Imjudo + Imfinzi + the platinum doublet chemo regimen on separate drug lines. Imjudo: J9347 75 units + JZ (three 25 mg vials, zero waste). Imfinzi: J9173 150 units + JZ (1,500 mg, zero waste). Chemo: HCPCS / NDC per the chosen regimen (e.g., carboplatin J9045 + pemetrexed J9305 for non-squamous; carboplatin + nab-paclitaxel for squamous). Admin codes: 96413 for initial drug, 96417 for each sequential drug (typically 2-3 sequential drugs per cycle), 96415 for any chair hour beyond the first. At cycle 5 (week 13) the regimen drops chemo and continues Imjudo + Imfinzi at week 16, then Imfinzi maintenance only from week 17 onward.

Pediatric eligibility?

Imjudo is not approved for pediatric patients (under 18). The FDA label states safety and effectiveness have not been established in pediatric patients for either the HIMALAYA HCC indication or the POSEIDON metastatic NSCLC indication. Pediatric off-label use will not be covered by commercial payers and is not aligned with NCCN guidance. Refer pediatric oncology cases to age-appropriate protocols.

PD-L1 testing for NSCLC?

PD-L1 IHC testing is not required for the POSEIDON metastatic NSCLC indication. POSEIDON enrolled regardless of PD-L1 expression and the FDA label does not include a PD-L1 cut-off. By contrast, Keytruda 1L NSCLC monotherapy requires PD-L1 22C3 IHC documentation. For POSEIDON PA, document EGFR-wildtype and ALK-negative status (a positive EGFR or ALK result would steer the patient to a targeted therapy first); PD-L1 documentation is helpful for regimen-selection appeals but not gating.

What is the Medicare reimbursement for J9347?

For Q2 2026, the Medicare Part B payment limit for J9347 is $143.228 per mg (ASP + 6%). The HCC STRIDE single 300 mg priming dose reimburses at approximately $42,968.40 (300 units × ASP+6%) — a one-time charge per patient. A single 75 mg POSEIDON dose reimburses at approximately $10,742.10; the full 5-dose POSEIDON Imjudo course reimburses at approximately $53,710.50. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS.

Source documents

1. AstraZeneca Access 360 — Imjudo Coding & Billing HCP page
   Document footers: AZ Codes & Coverage 2026
2. DailyMed — IMJUDO (tremelimumab-actl) Prescribing Information
   FDA-approved label, BLA 761289 (Oct 21, 2022 HIMALAYA HCC; Nov 10, 2022 POSEIDON NSCLC; latest label rev Jul 2024)
3. DailyMed — IMJUDO (tremelimumab-actl) current label (SetID 6690679c-be2f-4588-a2e4-89fff74dd6be, rev Jul 2024)
4. FDA — Tremelimumab + durvalumab approval for unresectable HCC (Oct 21, 2022)
5. FDA — Tremelimumab + durvalumab + platinum chemo approval for metastatic NSCLC (Nov 10, 2022)
6. HIMALAYA trial publication — NEJM (Abou-Alfa et al.)
   STRIDE: tremelimumab single 300 mg priming + durvalumab in unresectable HCC
7. POSEIDON trial publication — Journal of Clinical Oncology (Johnson et al.)
   Tremelimumab 75 mg q3w × 5 + durvalumab + platinum doublet chemo in 1L metastatic NSCLC
8. DailyMed — IMFINZI (durvalumab) Prescribing Information
   Combo partner reference; BLA 761069
9. CMS — Medicare Part B Drug ASP Pricing File
   Q2 2026 quarterly file, effective April 1 – June 30, 2026
10. SEER CanMED — HCPCS J9347 reference
11. NCCN Guidelines — Hepatobiliary Cancers, Non-Small Cell Lung Cancer
    HIMALAYA STRIDE and POSEIDON listed as Category 1 / preferred options
12. UnitedHealthcare — Oncology Medication Clinical Coverage Policy
13. Aetna CPB 0892 — Immune Checkpoint Inhibitors (covers Imjudo + Imfinzi + class)
14. AstraZeneca Access 360 — benefits investigation, PA assistance, copay program
    1-844-275-2360
15. FDA National Drug Code Directory

About this page

We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

Reviewer

Change log

• May 22, 2026 — SME audit: corrected FDA BLA reference from 761270 to 761289 (verified via FDA DISCO HCC approval announcement and DailyMed SetID 6690679c-be2f-4588-a2e4-89fff74dd6be). ASP data: Q2 2026 ($143.228/mg). Manufacturer source: AZ Access 360 (Apr 2026). FDA label: BLA 761289 (Oct 21, 2022 HIMALAYA HCC; Nov 10, 2022 POSEIDON metastatic NSCLC; latest label rev Jul 2024). Both regimens documented: HCC STRIDE single 300 mg priming dose + Imfinzi maintenance; NSCLC POSEIDON 75 mg q3w × 5 with Imfinzi + platinum chemo. Cross-referenced with Imfinzi (J9173) combo billing reference and Yervoy (J9228) CTLA-4 class comparison.

Methodology

Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list and regimen schedules are verified against the current FDA label revision and the HIMALAYA + POSEIDON trial publications. We do not paraphrase from billing-software vendor blogs.