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Stelara (ustekinumab) — HCPCS J3357 (SC) + J3358 (IV)

Janssen Biotech, Inc. · SC 45 mg / 90 mg PFS · IV 130 mg/26 mL SDV · Reference product (FDA-approved Sept 2009)

Stelara is Janssen's anti-IL-12/23 monoclonal antibody for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It uses two route-specific HCPCS codes — J3357 (SC) and J3358 (IV) — both at 1 mg per unit. The codes are mutually exclusive: never bill an IV vial under J3357 or an SC syringe under J3358. Q2 2026 Medicare reimbursement: $155.883/mg SC ($14,029.47 per 90 mg dose) and $11.624/mg IV ($4,533.36 per 390 mg induction). 7 FDA-approved biosimilars are now in market — Wezlana (interchangeable, the only biosimilar with split SC/IV codes), Selarsdi, Pyzchiva, Otulfi (interchangeable), Imuldosa, Steqeyma, and Yesintek — and CVS, Express Scripts, and OptumRx have all phased reference Stelara off preferred status in 2026 in favor of their captive private-label biosimilars.

✓ASP data:Q2 2026 (live)
✓Payer policies:verified May 2026
✓Manufacturer guide:Janssen 2025
✓FDA label:current revision
✓Page reviewed:

Instant Answer — the 5 things you need to bill Stelara

HCPCS
J3357
SC, 1 mg = 1 unit (J3358 for IV)
Maint. dose
90 units
90 mg SC q8wk (IBD) / q12wk (PsO)
Modifier
JZ
Whole-vial use; verify CMS list
Admin CPT
96365
IV induction (96372 for SC in office)
Medicare ASP+6%
$155.883
per mg SC, Q2 2026 · $14,029.47/90 mg dose
HCPCS descriptors
J3357 — "Ustekinumab, for subcutaneous injection, 1 mg" · J3358 — "Ustekinumab, for intravenous injection, 1 mg" Permanent
Effective date
Both codes effective January 1, 2018 (split from prior single ustekinumab code)
SC formulations
45 mg/0.5 mL prefilled syringe; 90 mg/1 mL prefilled syringe; 45 mg/0.5 mL single-dose vial
IV formulation
130 mg/26 mL (5 mg/mL) single-dose vial — weight-tiered induction only
Routes
Mutually exclusive. SC syringes ⇒ J3357. IV vial ⇒ J3358. Cross-billing is a hard error.
Benefit channel
SC (J3357): typically pharmacy benefit (specialty pharmacy + self-injection). IV (J3358): medical benefit (provider buy-and-bill).
Biosimilars
7 FDA-approved — Wezlana (Q5137 SC + Q5138 IV, interchangeable), Selarsdi (Q9998), Pyzchiva (Q9996), Otulfi (Q9999, interchangeable), Imuldosa (Q5098), Steqeyma (Q5099), Yesintek (Q5100)
Boxed warning
None. Section 5 W&P only: serious infections (TB, fungal, opportunistic), malignancy, hypersensitivity, PRES, non-infectious pneumonia
FDA approval
September 25, 2009 (BLA 125261) — first IL-12/23 inhibitor
Calculate patient estimate → Read full reference Compare 7 biosimilars →
ℹ️
Pharmacy benefit dominates SC; medical benefit covers IV induction. The 45 mg and 90 mg prefilled syringes are typically dispensed by specialty pharmacy and self-administered at home (pharmacy benefit, J3357 still applies on adjudication). The 130 mg IV vial used for Crohn's and ulcerative colitis induction is administered in an infusion suite and billed buy-and-bill on the medical benefit (J3358 + 96365). When SC maintenance is administered in-office (96372), it can be medical benefit if the practice acquires the syringe — verify benefit assignment with the payer for each patient.
⚠️
7 biosimilars in market — substitution is mandatory at most 2026 commercial plans. CVS Caremark places brand Stelara at parity with Pyzchiva (Cordavis private label) and Yesintek; Express Scripts removed brand Stelara IV from formulary January 2026 and is removing brand SC fully July 2026 (replacing with Selarsdi, ustekinumab-ttwe Quallent private label, and Yesintek); OptumRx is steering through Nuvaila private label. Pattern: each Big-3 PBM has its own captive biosimilar. See payer policy snapshot →
ℹ️
NO boxed warning. Stelara has Section 5 Warnings and Precautions only — serious infections (including TB, fungal, opportunistic infections), malignancy, hypersensitivity, posterior reversible encephalopathy syndrome (PRES), and non-infectious pneumonia. TB screening is required prior to initiation. This differs from other immunomodulators in the same therapeutic space — Humira (adalimumab) carries a boxed warning for serious infections and malignancy.
Phase 1 Identify what you're billing Two route-specific J-codes, four formulations, seven biosimilars — pick the right code first.

Stelara SC vs. IV — J3357 vs. J3358 CMS HCPCS verified May 2026

Same drug, two routes, two HCPCS codes. Mutually exclusive — never cross-bill.

Effective January 1, 2018, CMS split ustekinumab into two route-specific HCPCS codes: J3357 for the subcutaneous formulations (45 mg and 90 mg prefilled syringes, plus 45 mg vial) and J3358 for the intravenous formulation (130 mg single-dose vial used for IBD induction). Both codes describe 1 mg of ustekinumab per unit. The IV vial is only used for the one-time weight-tiered Crohn's or ulcerative colitis induction dose; all maintenance therapy — including the 90 mg q8wk maintenance dose for Crohn's and UC — is subcutaneous.

Stelara SCStelara IV
HCPCSJ3357J3358
HCPCS descriptor"Ustekinumab, for subcutaneous injection, 1 mg""Ustekinumab, for intravenous injection, 1 mg"
Code effectiveJanuary 1, 2018January 1, 2018
Formulations45 mg/0.5 mL PFS, 90 mg/1 mL PFS, 45 mg/0.5 mL SDV130 mg/26 mL (5 mg/mL) SDV
Indications usedPlaque psoriasis, PsA, Crohn's maintenance, UC maintenance, pediatricCrohn's induction, UC induction (adult); pediatric Crohn's induction (10-35 kg)
Typical doses45 mg, 90 mg (or 2.5 mg/kg pediatric)260 mg, 390 mg, 520 mg (weight-tiered)
Admin CPT96372 if in-office; no admin code if patient self-injects96365 (initial 1 hr) + 96366 (each add'l hr); ≥1 hr infusion
Benefit channelPharmacy benefit dominant (specialty Rx + self-inject)Medical benefit (buy-and-bill)
Q2 2026 ASP+6%$155.883/mg$11.624/mg
Mutually exclusive routes — never cross-bill. Billing the IV 130 mg vial under J3357 (SC code) is a hard error that will reject for NDC-to-HCPCS mismatch. Same for billing an SC syringe under J3358. The code follows the formulation administered, not the indication.
Why the per-mg ASP differs so dramatically: the SC and IV formulations have separate ASP calculations because they are separate NDCs with different unit economics. The SC PFS pricing reflects the prefilled-syringe convenience premium (and pharmacy-benefit channel); the IV vial is a high-volume, low- concentration vehicle for one-time induction. Both are real Q2 2026 CMS values.

The 7 ustekinumab biosimilars CMS HCPCS + FDA Purple Book verified May 2026

Wezlana, Selarsdi, Pyzchiva, Otulfi, Imuldosa, Steqeyma, Yesintek — the most-crowded biosimilar launch in U.S. history.

The Stelara biosimilar wave that began in late 2024 has produced seven FDA-approved ustekinumab biosimilars by mid-2026. Wezlana (Amgen) was the first interchangeable, designated October 2023. Otulfi (Formycon/Fresenius Kabi) became the second interchangeable in April 2025. The remaining five are biosimilar (not interchangeable) but most state pharmacy laws still permit substitution under standard biosimilar policies. Wezlana is the only biosimilar with split SC and IV HCPCS codes — all others have a single 1-mg-per-unit Q-code.

BrandGenericHCPCSManufacturerInterchangeable?Q2 2026 ASP+6%
Wezlana ustekinumab-auub Q5137 (SC) + Q5138 (IV) Amgen Yes (1st interchangeable, Oct 2023) $4.544/mg (IV)
Selarsdi ustekinumab-aekn Q9998 Alvotech / Teva No $11.754/mg
Pyzchiva ustekinumab-ttwe Q9996 (SC, 1 mg) Samsung Bioepis / Sandoz; CVS distributes as Cordavis private label No Pending publication
Otulfi ustekinumab-aauz Q9999 Formycon / Fresenius Kabi Yes (Apr 2025) $14.052/mg
Imuldosa ustekinumab-srlf Q5098 Accord / Intas (Samsung Bioepis manufactured) No Pending publication
Steqeyma ustekinumab-stba Q5099 Celltrion No $3.205/mg
Yesintek ustekinumab-kfce Q5100 Biocon No $3.354/mg
Wezlana is the only biosimilar with split SC/IV codes. Q5137 covers SC formulations, Q5138 covers the IV induction vial — the same architecture as the reference J3357 / J3358 split. Every other biosimilar uses a single 1 mg/unit code regardless of whether the SC or IV product is administered. For non-Wezlana biosimilars, route is captured by the NDC submitted with the claim.
Interchangeable ≠ automatic substitution. FDA interchangeable designation (Wezlana, Otulfi) means a pharmacist may substitute without prescriber intervention under most state laws. It does NOT mean payers automatically allow the substitution: PA criteria still apply, and most 2026 commercial plans steer to a specific biosimilar regardless of FDA interchangeability status. Confirm the payer-preferred product before dispensing.
Private-label / authorized-biosimilar dynamics: CVS distributes Pyzchiva as the Cordavis private label, Express Scripts distributes Pyzchiva as the Quallent private label, and OptumRx distributes through Nuvaila. The active ingredient is the same FDA-approved biosimilar — the brand name and labeler-NDC may differ from the manufacturer's own commercial NDC. Verify NDC against the dispensed product before submitting the claim.

Dosing — per indication FDA label current

From FDA prescribing information (BLA 125261).

Plaque psoriasis (adult, SC) — weight-tiered

  • ≤100 kg (~220 lb): 45 mg SC at week 0, week 4, then every 12 weeks
  • >100 kg: 90 mg SC at week 0, week 4, then every 12 weeks

Psoriatic arthritis (adult, SC)

  • 45 mg SC at week 0, week 4, then every 12 weeks
  • 90 mg if >100 kg with coexistent moderate-to-severe plaque psoriasis

Crohn's disease & ulcerative colitis (adult) — IV induction + SC maintenance

Step 1 — weight-tiered IV induction (single dose, J3358):

Patient weightIV induction dose130 mg vials needed
≤55 kg (~121 lb)260 mg2 vials
56 – 85 kg (~187 lb)390 mg3 vials
>85 kg520 mg4 vials

Step 2 — SC maintenance (J3357): 90 mg SC 8 weeks after IV induction, then 90 mg SC every 8 weeks thereafter.

Pediatric Crohn's disease (≥2 years) — weight-tiered

  • 10 – 35 kg: 2.5 mg/kg IV induction, then weight-based SC maintenance every 8 weeks
  • >35 kg: 90 mg IV induction (using 130 mg vial — partial use), then 90 mg SC every 8 weeks

Note: pediatric Crohn's is approved at ≥2 years. Pediatric plaque psoriasis and pediatric PsA are approved at ≥6 years. Pediatric UC is not approved.

Worked example — adult plaque psoriasis maintenance

# 90 mg SC dose (patient >100 kg)
Drug units billed: 90
HCPCS: J3357 (SC) · Modifier: JZ (whole-vial use) · PFS: 1 × 90 mg/1 mL
Admin: 96372 if in office, none if self-injected

# Maintenance schedule: q12wk (psoriasis / PsA)
# Year-1 dose count: 5 doses (week 0, 4, 16, 28, 40)
# Total year-1 J3357 units: 450 (5 × 90)

Worked example — adult Crohn's induction + first maintenance

# Patient 70 kg — weight tier 56-85 kg
Step 1 (IV induction): 390 units of J3358 · 3 × 130 mg vials
Admin: 96365 (1 hr) + 96366 if >1 hr

# Week 8: SC maintenance begins
Step 2 (first SC dose): 90 units of J3357 · 1 × 90 mg PFS
Admin: 96372 if in office

# Subsequent maintenance: 90 mg SC q8wk indefinitely

Pre-initiation requirements (per FDA label)

  • Tuberculosis screening required prior to first dose; treat latent TB before initiation
  • Evaluate for active infection; do not initiate during clinically important active infection
  • Update vaccinations per current immunization guidelines (live vaccines contraindicated during therapy)
  • Baseline malignancy risk assessment

NDC reference FDA NDC Directory verified May 2026

Janssen Biotech labeler 57894. Biosimilar NDCs vary by labeler — verify product on dispense.

NDC (11-digit)ProductPackageCode routes to
57894-061-03 Stelara SC PFS 90 mg/1 mL Single-dose prefilled syringe J3357 (SC)
57894-060-03 Stelara SC PFS 45 mg/0.5 mL Single-dose prefilled syringe J3357 (SC)
57894-060-02 Stelara SC vial 45 mg/0.5 mL Single-dose vial J3357 (SC)
57894-054-27 Stelara IV vial 130 mg/26 mL (5 mg/mL) Single-dose vial J3358 (IV)
11-digit NDC required on most claim forms. Janssen NDCs print in 10-digit form on labels; pad the appropriate segment with a leading zero for claim submission. Use the N4 qualifier in CMS-1500 Box 24A and UB-04 Box 43.
Biosimilar NDCs: each biosimilar has its own labeler/NDC. Private-label distributions (Cordavis, Quallent, Nuvaila) may use a re-labeled NDC distinct from the manufacturer's own commercial NDC for the same biosimilar. Always verify NDC against the dispensed package; the NDC drives J/Q-code routing and ASP price look-up.
Phase 2 Code the claim Build the line items: admin code (different for SC vs IV), modifiers, ICD-10, site of care.

Administration codes CPT verified May 2026

Stelara is non-chemotherapeutic — therapeutic IV codes for induction, SC injection code for in-office maintenance.

CodeDescriptionWhen to use
96365 IV infusion, for therapy/prophylaxis/diagnosis; initial, up to 1 hour Primary code for IV induction (J3358). Stelara IV infuses over at least 1 hour.
96366 IV infusion, for therapy/prophylaxis/diagnosis; each additional hour Bill if infusion exceeds 1 hour (common with the larger 520 mg / 4-vial doses).
96372 Therapeutic, prophylactic, or diagnostic injection; SC or IM Use for SC Stelara administered in-office. Not billable when patient self-injects.
96413 / 96415 Chemotherapy IV administration codes Not appropriate. Ustekinumab is non-chemotherapeutic.
No admin code Patient self-administers SC at home (typical psoriasis / PsA maintenance) Practice does not bill admin; specialty pharmacy dispenses; J3357 still applies on Rx adjudication.
Why not chemo: ustekinumab (anti-IL-12/23) is a non-chemotherapeutic biologic. Chemo admin codes (96413, 96415) are only appropriate for cytotoxic chemotherapy, monoclonal-antibody anti-cancer therapeutics in oncology contexts, and a narrow list of complex biologics. Stelara is none of these. Don't bill chemo admin codes for the higher reimbursement — documentation won't support it.

Modifiers CMS verified May 2026 — verify JZ list

JZ — whole-vial use, default expectation

Effective July 1, 2023, CMS requires JZ on all claims for single-dose container drugs when no drug is discarded — but only for codes on the CMS single-dose container list. Most Stelara doses use whole vials or the full PFS, so JZ is the expected modifier when no drug is wasted. Verify applicability at billing time against the current CMS single-dose container list.

JW — only when discard is documented

For weight-tiered IV induction, dosing rarely exhausts vials cleanly. A 70 kg adult on the 56-85 kg tier receives 390 mg = 3 × 130 mg vials = exact (no waste). A 90 kg adult on the >85 kg tier receives 520 mg = 4 × 130 mg vials = exact. Pediatric weight-based dosing (2.5 mg/kg) is more likely to leave residual drug; document any wastage and report on a separate JW line.

JZ/JW reporting tip: default behavior is to include JZ when no drug is wasted. If the dose leaves residual product (most common in pediatric weight-based IV induction), report the administered amount without JZ on the primary line and the wasted amount on a separate line with the JW modifier — per CMS billing guidance.

Modifier 25 — situational

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 or injection. Routine pre-administration screening is bundled.

340B modifiers (JG, TB)

For 340B-acquired Stelara, follow your MAC's current 340B modifier policy.

ICD-10-CM diagnosis codes FY2026 verified May 2026

Stelara's full diagnosis space spans dermatology, rheumatology, and gastroenterology.

Plaque psoriasis

ICD-10DescriptionStelara-eligible?
L40.0Psoriasis vulgaris (plaque psoriasis)Yes (primary indication)
L40.8Other psoriasisCase-by-case; payer policies vary
L40.9Psoriasis, unspecifiedOften rejected; specify L40.0

Psoriatic arthritis

ICD-10DescriptionStelara-eligible?
L40.50Arthropathic psoriasis, unspecifiedAcceptable; prefer specific L40.5x
L40.51Distal interphalangeal psoriatic arthropathyYes
L40.52Psoriatic arthritis mutilansYes
L40.53Psoriatic spondylitisYes
L40.54Psoriatic juvenile arthropathyYes (pediatric ≥6)
L40.59Other psoriatic arthropathyYes
M07.30 / M07.60Juvenile psoriatic arthropathy (alt coding)Used in pediatric rheum contexts

Crohn's disease

ICD-10DescriptionStelara-eligible?
K50.00 / K50.01xCrohn's of small intestine (without/with complications)Yes
K50.10 / K50.11xCrohn's of large intestine (without/with complications)Yes
K50.80 / K50.81xCrohn's of both small + large intestineYes
K50.90 / K50.91xCrohn's, unspecifiedYes

Ulcerative colitis

ICD-10DescriptionStelara-eligible?
K51.00 / K51.01xUlcerative pancolitis (without/with complications)Yes
K51.20 / K51.21xUlcerative proctitisYes
K51.30 / K51.31xUlcerative rectosigmoiditisYes
K51.40 / K51.41xPseudopolyposis of colonIf UC-related
K51.50 / K51.51xLeft-sided colitisYes
K51.80 / K51.81xOther ulcerative colitisYes
K51.90 / K51.91xUlcerative colitis, unspecifiedYes
PA pathways differ by indication. For psoriasis and PsA, most payers require documented inadequate response, intolerance, or contraindication to one or more conventional therapies (often including topicals, phototherapy for PsO; methotrexate or other DMARDs for PsA). For Crohn's and UC, payers typically require documented inadequate response, intolerance, or contraindication to a TNF inhibitor (e.g., infliximab, adalimumab) before approving ustekinumab. The IBD pathway is more restrictive than the dermatology pathway.

Site of care & place of service Verified May 2026

Stelara IV induction (J3358) requires an infusion suite for the ≥1-hour infusion. Stelara SC (J3357) is almost always self-administered at home after specialty pharmacy dispense; in-office SC administration is used when the patient is needle-averse, has dexterity issues, or per practice protocol. UHC, Aetna, and Cigna all run site-of-care UM programs that steer infused biologics away from hospital outpatient toward non-hospital infusion sites.

SettingPOSClaim formElectronicUsed for
Physician office11CMS-1500837PSC injection (96372); occasionally IV induction
Ambulatory infusion suite49CMS-1500837PIV induction (J3358 + 96365)
Hospital outpatient19 or 22UB-04 / CMS-1450837IIV induction (typically site-of-care UM target)
Patient home (pharmacy benefit)n/a (Rx claim)NCPDPD.0SC self-injection — specialty pharmacy
Patient home (medical benefit)12CMS-1500837PHome-infusion vendor for IV; rare for ustekinumab
Site-of-care programs target IV induction specifically. Because Stelara IV induction is a single dose per patient (then transitions to SC), the site-of-care steering effect is more limited than for chronic infused biologics — but UHC and Aetna still prefer non-hospital sites for the induction. SC maintenance is rarely a site-of-care target since most patients self-inject.

Claim form field mapping Verified May 2026

CMS-1500 / 837P (physician office, AIC; POS 11/49) for medical-benefit billing.

InformationCMS-1500 boxNotes
NPI17bRendering provider
NDC qualifier + 11-digit NDC + UoM + qty24A shaded areaSC PFS 90 mg: N457894061031ML1 · IV vial 130 mg: N457894054271ML26
HCPCS J3357 (SC) or J3358 (IV) + admin CPT24DEach on its own line; admin CPT differs by route (96365 IV vs 96372 SC)
Drug units24GSC: typically 45 or 90 (mg) · IV: 260, 390, or 520 (mg) for adult induction
ICD-1021L40.0 (PsO); L40.5x (PsA); K50.x (Crohn's); K51.x (UC)
PA number23Required by virtually all commercial payers

Form references: NUCC (CMS-1500).

Phase 3 Get paid PBM private-label biosimilars dominate 2026 — reference Stelara is being phased off most preferred lists.

Payer policy snapshot — PBM biosimilar substitution 2026 Reviewed May 2026

Each Big-3 PBM steers to its own captive private-label biosimilar. Brand Stelara is being phased out aggressively in 2026.

Payer / PBM2026 Stelara statusPreferred biosimilar(s)Action required
CVS Caremark
National formulary 2026		 Brand Stelara at parity with Cordavis private label and Yesintek Pyzchiva (Cordavis private label, Samsung Bioepis); Yesintek (Biocon) Brand may continue but biosimilar is operationally preferred at retail dispense
Express Scripts
National formulary 2026		 Brand IV removed Jan 2026; brand SC removed July 2026 Selarsdi (Alvotech/Teva); ustekinumab-ttwe (Quallent private label, Samsung Bioepis); Yesintek (Biocon) Mandatory transition to a preferred biosimilar at re-authorization or by July 2026
OptumRx
2026 formulary updates		 Heavy steerage to Nuvaila (private-label biosimilar) Nuvaila private-label distribution of an FDA-approved biosimilar Brand restricted; transition to Nuvaila at re-authorization
UnitedHealthcare
Combined ustekinumab policy		 Brand and biosimilars both covered; PA required OptumRx-aligned (Nuvaila preferred for OptumRx-managed plans) PA criteria focus on indication + step therapy
Aetna / CVS Health
CPB ustekinumab		 Aligned with CVS Caremark formulary Pyzchiva (Cordavis) / Yesintek PA required; biosimilar preferred at re-auth
Drug Channels (April 2026): the Big-3 PBMs have largely removed reference Stelara from preferred status by mid-2026. The dominant pattern is each PBM steering to its own captive private-label biosimilar — not necessarily the lowest-WAC product on the market. For a given patient, the "preferred" biosimilar depends on which PBM administers their pharmacy benefit, not on biosimilar clinical equivalence.
Key finding: 2026 is the year of mandatory ustekinumab biosimilar substitution at most commercial plans. Existing patients stable on brand Stelara are being transitioned at re-authorization; new starts are required to initiate on the payer-preferred biosimilar. Medicare Part D plans follow CMS formulary guidance, which still allows brand Stelara coverage but is increasingly tiered higher than biosimilars.

What to document for approval

  • Confirmed indication (PsO, PsA, Crohn's, UC) with appropriate ICD-10
  • For IBD: documented inadequate response, intolerance, or contraindication to a TNF inhibitor
  • For PsO/PsA: documented trial of conventional systemic therapy (or contraindication)
  • Negative TB screening (PPD, IGRA, or chest X-ray) — required by FDA label
  • Weight (drives dose tier for PsO >100 kg and IV induction tier)
  • For re-authorization: documented clinical response (PASI improvement, disease activity score, etc.)
  • Payer-preferred biosimilar attempt or contraindication if requesting brand Stelara on a plan that mandates biosimilar

Medicare reimbursement CMS Q2 2026 (live)

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

Q2 2026 payment snapshot — J3357 (SC, primary)

Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions

ASP + 6%
$155.883
per mg / per unit
90 mg dose
$14,029.47
90 units × ASP+6%
After sequestration
~$13,749
~2% reduction (actual paid)

Q2 2026 IV reimbursement — J3358

CodeASP+6% per mgCommon adult dosePer-dose payment
J3358$11.624260 mg (≤55 kg)~$3,022.24
J3358$11.624390 mg (56-85 kg)~$4,533.36
J3358$11.624520 mg (>85 kg)~$6,044.48

Biosimilar Q-codes — Q2 2026 ASP+6%

CodeBrandASP+6%/mgvs. brand
Q5138 (IV)Wezlana IV$4.544~61% lower than J3358 IV
Q5099Steqeyma$3.205~72% lower than J3358 IV
Q5100Yesintek$3.354~71% lower than J3358 IV
Q9998Selarsdi$11.754Near parity with J3358
Q9999Otulfi$14.052Slight premium to J3358 IV (early launch)
Q5137 Wezlana SC, Q9996 Pyzchiva, Q5098 Imuldosa not yet in MEDICARE_ASP file at time of publication.
Annualized Stelara cost example — adult plaque psoriasis >100 kg: 5 doses/year × $14,029.47 = ~$70,147/year before sequestration and copay assistance. Crohn's / UC year-1 (one IV induction + ~6 SC maintenance doses): ~$4,533 IV induction + ~$84,177 SC maintenance = ~$88,710 year 1; subsequent years ~$91,191 (6.5 SC maintenance doses/yr).

Coverage

No NCD specific to ustekinumab. Coverage falls under generic drug-coverage LCD framework (e.g., LCD L33394). All MACs cover J3357 and J3358 for FDA-approved on-label indications. Bill with appropriate ICD-10 (L40.0 for PsO, L40.5x for PsA, K50.x for Crohn's, K51.x for UC).

Code history

  • September 2009 — Stelara FDA approval; initially billed under unclassified codes
  • 2014 — ustekinumab assigned to a single J-code
  • January 1, 2018 — CMS split into J3357 (SC) and J3358 (IV) to reflect distinct ASP economics for each route
  • 2024 – 2026 — biosimilar Q-codes added: Q5137/Q5138 (Wezlana, 2024), Q9998 (Selarsdi), Q9996 (Pyzchiva), Q9999 (Otulfi), Q5098 (Imuldosa), Q5099 (Steqeyma), Q5100 (Yesintek)

Patient assistance — Janssen CarePath + foundations Janssen verified May 2026

  • Janssen CarePath: commercial copay assistance for eligible patients (excludes Medicare, Medicaid, federal program patients). Copay support varies by indication and plan year.
  • Janssen Patient Assistance Foundation (JJPAF): free product for eligible uninsured / underinsured patients. Income-based eligibility.
  • Janssen Compassionate Use Program: emergency / coverage gap support.
  • PAN Foundation: Crohn's, ulcerative colitis, psoriasis, and inflammatory bowel disease funds (open status varies)
  • HealthWell Foundation: dermatology and IBD funds (open status varies)
  • Patient Advocate Foundation: case management and copay relief for chronic conditions
  • Web: stelarainfo.com · janssencarepath.com/patient/stelara
Biosimilar copay programs: each manufacturer runs its own commercial copay program for the ustekinumab biosimilar it sells (Amgen for Wezlana, Teva for Selarsdi, Sandoz for Pyzchiva, etc.). For patients transitioning from brand Stelara to a biosimilar at re-authorization, evaluate the new program's eligibility separately — CarePath does not transfer.
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance, and OOP max? Run a CareCost Estimate — J3357 pre-loaded.
Phase 4 Fix problems Wrong route code (J3357 vs J3358), biosimilar substitution at re-auth, and TB screening gaps are the top three.

Common denials & how to fix them

Denial reasonCommon causeFix
NDC-to-HCPCS mismatch IV vial NDC (57894-054-27) billed under SC code J3357, or SC PFS NDC billed under IV code J3358 Re-submit with correct route code: J3357 for SC syringes/vial, J3358 for the 130 mg IV vial. Confirm NDC matches the formulation administered.
Biosimilar substitution required at re-auth 2026 PBM formulary phased brand Stelara off preferred status If patient is stable on brand, appeal with continuity-of-care + clinical response documentation. If transition is required, identify payer-preferred biosimilar (Pyzchiva for CVS, Selarsdi or ustekinumab-ttwe for ESI, Nuvaila for Optum) and re-initiate PA under the new product's HCPCS.
Missing TB screening FDA-required TB screening not documented prior to first dose Submit PPD / IGRA result, or chest X-ray + clinical exclusion. Required by FDA label and most payer PA criteria.
Wrong admin code (96365 for SC) IV admin code billed for an SC injection Resubmit with 96372 (SC injection) for in-office SC dose; do not bill admin if patient self-injects.
Wrong admin code (96413 chemo) Chemo admin code billed for non-chemo ustekinumab Resubmit with 96365 (initial 1 hr) for IV induction. Always 96365 for ustekinumab IV.
JZ/JW modifier dispute MAC interpretation of single-dose container list inconsistent Verify CMS list at billing time. Default: include JZ when no waste; report wasted amount on separate line with JW when applicable (most common in pediatric weight-based dosing).
Step therapy — missing TNF failure (IBD) Crohn's or UC PA submitted without documented TNF-inhibitor inadequate response/intolerance Submit prior TNF treatment history (infliximab, adalimumab, certolizumab). Most payers require this for the IBD indications.
Pediatric dose/age mismatch Pediatric Crohn's billed under age <2; pediatric PsO/PsA under age <6 Verify age at administration. Crohn's is approved ≥2 years; psoriasis and PsA ≥6 years; UC adults only. Off-label use requires manual medical-necessity review.
NDC format 10-digit NDC submitted; payer requires 11-digit Use 11-digit form with N4 qualifier. Pad appropriate segment with leading zero.
Weight-tier mismatch (IV induction) 390 mg billed for >85 kg patient (should be 520 mg) or vice versa Verify weight at induction; bill the correct tier. Document weight in note.

Frequently asked questions

What is the HCPCS code for Stelara?

Stelara (ustekinumab) uses two route-specific HCPCS codes, both effective January 1, 2018 and both billed at 1 mg = 1 unit. J3357 — "Ustekinumab, for subcutaneous injection, 1 mg" — covers the 45 mg and 90 mg prefilled syringes. J3358 — "Ustekinumab, for intravenous injection, 1 mg" — covers the 130 mg single-dose vial used for Crohn's and ulcerative colitis induction. The two codes are mutually exclusive: never bill an IV vial under J3357, and never bill an SC syringe under J3358.

How is Stelara dosed?

Plaque psoriasis and PsA (adult, SC): 45 mg SC at week 0, week 4, then every 12 weeks (90 mg if >100 kg). Crohn's and UC: a single weight-tiered IV induction dose (260 mg if ≤55 kg, 390 mg if 56-85 kg, 520 mg if >85 kg) followed 8 weeks later by 90 mg SC every 8 weeks for maintenance. Pediatric Crohn's (≥2 years): 2.5 mg/kg IV induction if 10-35 kg, 90 mg q8wk SC if >35 kg. Pediatric psoriasis and PsA approved at ≥6 years.

Is Stelara billed under pharmacy or medical benefit?

Both, depending on the formulation. The 45 mg and 90 mg prefilled syringes are typically dispensed by specialty pharmacy and self-administered — pharmacy benefit. The 130 mg IV induction vial is administered in an infusion suite and billed buy-and-bill on the medical benefit (J3358 + 96365 admin). When SC maintenance is given in-office (96372), it can be medical benefit if the practice acquires the syringe; most practices route SC through pharmacy.

What are the FDA-approved Stelara biosimilars?

Seven as of May 2026: Wezlana (ustekinumab-auub, Amgen — first interchangeable, October 2023, Q5137 SC + Q5138 IV); Selarsdi (ustekinumab-aekn, Alvotech/Teva, Q9998); Pyzchiva (ustekinumab-ttwe, Samsung Bioepis/Sandoz, Q9996; CVS distributes as Cordavis private label); Otulfi (ustekinumab-aauz, Formycon/Fresenius Kabi, Q9999 — interchangeable April 2025); Imuldosa (ustekinumab-srlf, Accord/Intas/Samsung Bioepis, Q5098); Steqeyma (ustekinumab-stba, Celltrion, Q5099); and Yesintek (ustekinumab-kfce, Biocon, Q5100). Wezlana is the only biosimilar with split SC and IV codes.

Does Stelara have a boxed warning?

No. Stelara does not carry a boxed warning. Section 5 (Warnings and Precautions) of the FDA label highlights serious infections (including tuberculosis, fungal, and other opportunistic infections), malignancy, hypersensitivity, posterior reversible encephalopathy syndrome (PRES), and non-infectious pneumonia. Tuberculosis screening is required prior to initiation. This differs from other immunomodulators in the same therapeutic space — Humira (adalimumab) does carry a boxed warning for serious infections and malignancy.

What is the administration code for Stelara?

For IV induction: CPT 96365 (initial up to 1 hour) plus 96366 for each additional hour — Stelara IV infuses over at least 1 hour. Ustekinumab is non-chemotherapeutic, so 96413 / 96415 (chemo administration) are NOT appropriate. For SC administration in office: CPT 96372 (therapeutic SC injection). When patients self-inject at home, no admin code is billed by the practice.

Are payers steering Stelara patients to biosimilars in 2026?

Yes — aggressively. Each Big-3 PBM has now phased reference Stelara off preferred status in favor of its own captive private-label biosimilar. CVS Caremark places brand Stelara at parity with Pyzchiva (Cordavis private label) and Yesintek. Express Scripts removed brand Stelara IV from formulary January 2026 and is removing brand SC fully July 2026, replacing with Selarsdi, ustekinumab-ttwe (Quallent private label), and Yesintek. OptumRx is steering through Nuvaila private label. By mid-2026, most commercial Stelara patients will be required to switch to a biosimilar at re-authorization.

What is the Medicare reimbursement for Stelara?

For Q2 2026, the Medicare Part B payment limit for J3357 (SC) is approximately $155.883 per mg (ASP + 6%), making a 90 mg maintenance dose approximately $14,029.47 before sequestration. J3358 (IV) is approximately $11.624 per mg, making a 390 mg induction dose approximately $4,533.36. The dramatic difference between SC and IV per-mg pricing is real and reflects the very different ASP economics of each formulation. Biosimilar Q-codes price substantially below brand. ASP refreshes quarterly.

What ICD-10 codes support Stelara coverage?

L40.0 (psoriasis vulgaris / plaque psoriasis), L40.50-L40.59 (psoriatic arthritis), K50.x family (Crohn's disease), K51.x family (ulcerative colitis), and M07.30 / M07.60 for juvenile psoriatic arthritis when applicable. Most commercial payers require documented inadequate response, intolerance, or contraindication to one or more conventional therapies (e.g., methotrexate, TNF inhibitor) before approving ustekinumab for the IBD indications, with somewhat more flexible criteria for plaque psoriasis.

Reference Sources & methodology Every claim on this page is sourced. Methodology and review history below.

Source documents

  1. DailyMed — STELARA (ustekinumab) Prescribing Information
    FDA-approved label (BLA 125261)
  2. Janssen — STELARA Prescribing Information PDF
    Manufacturer-hosted full prescribing information (no boxed warning; W&P only)
  3. CMS — Medicare Part B Drug ASP Pricing File
    Q2 2026 quarterly file, effective April 1 – June 30, 2026
  4. CMS — HCPCS quarterly update file (canonical J/Q-code source)
  5. FDA — Purple Book of licensed biological products
    Authoritative source for biosimilar approval and interchangeable designation
  6. AAPC — HCPCS J3357
  7. AAPC — HCPCS J3358
  8. FDA National Drug Code Directory
  9. FDA — First interchangeable biosimilar to Stelara approved (Wezlana, Oct 2023)
  10. Drug Channels — PBM Stelara biosimilar formulary analysis (April 2026)
    Independent PBM formulary tracking; private-label biosimilar dynamics
  11. CVS Caremark — 2026 national formulary (ustekinumab section)
  12. Express Scripts — 2026 national formulary updates (Stelara IV / SC removal schedule)
  13. OptumRx — 2026 formulary (Nuvaila private label)
  14. Janssen CarePath — Stelara patient support

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 — with extra cadence on biosimilar Q-codes and PBM formulary actions during the 2026 substitution wave.

Found an error? Email hello@carecostestimate.com.

Refresh cadence

ElementCadenceHow it's refreshed
Medicare ASP pricing (J3357, J3358, biosimilar Q-codes)QuarterlyAuto-bound to CareCost ASP layer; updates on CMS file release.
Payer policies (CVS, ESI, OptumRx, UHC, Aetna)Semi-annual + event-drivenManual review against published payer/PBM policy documents. Extra reviews during 2026 substitution wave.
HCPCS / CPT / modifier rules + CMS single-dose container listQuarterlyJZ/JW applicability verified each quarter.
NDC, dosing, FDA labelEvent-drivenTied to manufacturer document version + FDA label revision date.
Biosimilar landscapeQuarterlyFDA Purple Book + CMS HCPCS quarterly file; new approvals and interchangeable designations tracked.
PBM private-label distributionQuarterlyCordavis (CVS), Quallent (ESI), Nuvaila (Optum) brand assignments verified each quarter.

Reviewer

Pending SME review. This page is staff-authored from primary sources (FDA, CMS, manufacturer, payer documents — all linked above). Final review by our SME, Catherine Rose (CPC), is in progress. Until that review is complete, treat this as a draft reference and verify each cited source for high-stakes claims.

Change log

  • — Initial publication. ASP data: Q2 2026 (J3357 = $155.883/mg SC; J3358 = $11.624/mg IV). All 7 biosimilars catalogued (Wezlana Q5137/Q5138; Selarsdi Q9998; Pyzchiva Q9996; Otulfi Q9999; Imuldosa Q5098; Steqeyma Q5099; Yesintek Q5100). Payer policies: CVS, ESI, OptumRx 2026 formulary actions documented.

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 and from the Drug Channels independent PBM formulary analysis. We do not paraphrase from billing-software vendor blogs. When CMS guidance is ambiguous (as with the natalizumab single-dose container list), we surface the ambiguity rather than asserting a definitive answer. Biosimilar landscape is verified against the FDA Purple Book and the CMS HCPCS quarterly update file.

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