Codes & NDC — reference + 7 biosimilars
| HCPCS | Product | Notes |
|---|
J3357 | Stelara SC (reference) | 1 mg/unit · 45 mg or 90 mg PFS |
J3358 | Stelara IV (reference) | 1 mg/unit · 130 mg/26 mL SDV (IBD induction) |
Q5137 / Q5138 | Wezlana (Amgen) SC / IV | 1 mg/unit · Interchangeable · only biosim w/ split codes |
Q9998 | Selarsdi (Alvotech/Teva) | ustekinumab-aekn · 1 mg/unit |
Q9996 | Pyzchiva (Samsung Bioepis) | ustekinumab-ttwe · CVS Cordavis private label |
Q9999 | Otulfi (Fresenius Kabi) | ustekinumab-aauz · Interchangeable |
Q5098 | Imuldosa (Accord/Dong-A) | ustekinumab-srlf |
Q5099 | Steqeyma (Celltrion) | ustekinumab-stba |
Q5100 | Yesintek (Biocon) | ustekinumab-kfce |
| NDC | Stelara 90 mg PFS 57894-0061-03 · IV 130 mg vial 57894-0054-01 · biosim NDCs vary |
PBM private labels: CVS distributes Pyzchiva as Cordavis; ESI distributes ustekinumab-ttwe as Quallent; OptumRx steers via Nuvaila. Same FDA biosim, different brand/NDC.
Dosing
| Indication | Induction | Maintenance |
|---|
| Plaque PsO / PsA | 45 or 90 mg SC wk 0 & wk 4 | SC q12wk (90 mg if >100 kg) |
| Crohn's (adult) | IV J3358 weight-tiered (see below) | 90 mg SC wk 8, then q8wk |
| UC (adult) | IV J3358 weight-tiered | 90 mg SC wk 8, then q8wk |
| Pediatric Crohn's (10-35 kg) | 2.5 mg/kg IV induction | Weight-based SC q8wk |
IBD IV induction (J3358) — weight tiers:
| Weight | Dose | Vials |
|---|
| ≤55 kg | 260 mg | 2 |
| 56–85 kg | 390 mg | 3 |
| >85 kg | 520 mg | 4 |
Admin & modifiers
| Code | When |
|---|
96365 | IV induction (J3358), ≥1 hour, non-chemo |
96366 | Each add'l hour (520 mg / 4-vial doses common) |
96372 | SC in-office (J3357) — rare |
JZ | Whole-vial / whole-PFS use, no waste |
JW | Discarded drug from SDV (occasional with weight-tiered IV) |
Hard error: never bill SC syringe under J3358, never bill IV vial under J3357. NDC-to-HCPCS mismatch will reject. Code follows the formulation administered.
ICD-10
| Indication | ICD-10 |
|---|
| Plaque psoriasis | L40.0 |
| PsA | L40.5x |
| Crohn's | K50.x (00/01/10/11/80/81/90/91) |
| UC | K51.x |
| Pediatric Crohn's (≥6, weight-based) | K50.x |
Payer / PBM — 2026
| PBM | Brand Stelara | Preferred biosimilar |
|---|
| CVS Caremark | At parity with Cordavis | Pyzchiva (Cordavis), Yesintek |
| Express Scripts | Removed by Jul 2026 | Selarsdi, Quallent (ttwe), Yesintek |
| OptumRx | Restricted | Nuvaila private label |
Each Big-3 PBM has captive biosimilar. PA + step therapy through preferred biosim required. IBD pathway more restrictive than dermatology — often requires prior anti-TNF failure.
Medicare reimbursement (Q2 2026)
| Code | ASP+6% | Per dose |
|---|
| J3357 (SC) | $155.883/mg | $14,029.47 / 90 mg |
| J3358 (IV) | $11.624/mg | $4,533.36 / 390 mg induction |
| Annual Crohn's maint. | ~6.5 doses/yr SC = ~$91,191 (J3357 only) |
SC and IV ASPs differ dramatically — separate AMP submissions, different distribution. Both are real Q2 2026 CMS values.
Site of care
| Setting | POS | Notes |
|---|
| Patient home (SC) | 12 | Default for J3357 maintenance — pharmacy benefit |
| Ambulatory infusion suite | 49 | IV induction (J3358 + 96365) |
| Physician office | 11 | SC in-office (J3357 + 96372) or IV induction |
| Hospital outpatient | 19/22 | UM disfavors |
Patient assistance — Janssen CarePath
- Janssen CarePath: 1-877-CarePath (1-877-227-3728) — benefits investigation, PA support, copay
- Stelara withMe Savings Program: commercial pts — copay as low as $5/dose (excl. Medicare/Medicaid/federal)
- Janssen Patient Assistance Foundation (JJPAF): free product for uninsured / income-qualifying
- Web: stelarahcp.com / janssencarepath.com
- Biosimilar manufacturers run separate copay programs
BOXED WARNING: (1) SERIOUS INFECTIONS — TB (latent + active), invasive fungal, opportunistic. TB screening required pre-initiation. (2) MALIGNANCY. Also W&P: hypersensitivity, PRES, non-infectious pneumonia.