Stelara (ustekinumab) — J3358

Stelara and the ustekinumab biosimilar family

Stelara IV (ustekinumab) bills under J3358, 1 mg per billing unit, from Janssen (Johnson & Johnson), an interleukin-12 and -23 antagonist for moderately to severely active Crohn's disease and ulcerative colitis. Seven ustekinumab biosimilars are priced this quarter, each with its own IV code.

Payers frequently steer the claim toward a specific product: 17 of the 29 commercial payers in the Clearance corpus name a preferred ustekinumab product, and 27 of 29 require some other product tried first (see Coverage & access).

Vial and NDC

One vial size supplies every adult band: two vials for 260 mg, three for the 390 mg worked example, four for 520 mg, all with nothing discarded (JZ). The pediatric 10 mg/kg dose is the exception: a 20 kg child draws 200 mg from two vials with 60 mg discarded, the only JW case.

All eight codes bill per 1 mg, so a patient's dose converts to the same unit count on any of them; only the rate changes. None of the seven biosimilars carries a manufacturer or foundation program record in this bundle.

This reference does not recommend one ustekinumab product over another. The payer's own preferred-product and step-therapy rules, not a clinical preference, decide which code a given patient's claim can carry (see Cost & financial access).

Stelara dosing

Ustekinumab's induction dose is one intravenous infusion set by body weight (260, 390 or 520 mg for adults, 10 mg/kg for children 10 kg to 25 kg), then a 90 mg subcutaneous syringe every 8 weeks. JZ applies at every adult band; JW applies only to the pediatric per-kilogram dose.

Hypersensitivity reactions

Stelara carries no boxed warning. Serious hypersensitivity reactions are the safety signal most relevant to the IV induction dose; the label's language:

Pre-treatment documentation

• Evaluate for tuberculosis before starting; treat latent TB before the first dose.
• Complete age-appropriate immunizations before starting; live vaccines are not given during treatment.
• Confirm the payer's step-therapy requirement (conventional therapy first, then often a specific preferred ustekinumab product) before scheduling the infusion (see Coverage & access).
• Most payers authorize the infusion itself as a one-time fill: Premera writes that it “may be approved for 30-days to allow for a one-time induction dose,” while the SC maintenance syringe is what gets reauthorized, typically every 12 months.

Need the units for a patient's dose? Convert dose to J3358 billing units →

Stelara billing reference

HCPCS

J3358 bills 1 mg per unit. The one-time induction dose is set by body weight: 260, 390 or 520 mg for adults (260, 390 or 520 units), or 10 mg/kg for children 10 kg to 25 kg.

NDC

One vial size, one code, for the IV induction dose. See the vial table in Drug & products above. The claim-form NDC is 57894-054-27 for the 130 mg/26 mL vial; the number of vials on the claim depends on the weight band (two, three or four).

Administration

A single code, not a choice: Stelara's induction dose is infused over at least one hour, billed with 96365 alone. CPT 96365–96366 carries the complete code definitions.

Modifiers

JZ: required when no drug is discarded. JW: required for documented waste.

The three adult bands (260, 390 and 520 mg) are exact multiples of the 130 mg vial, so JZ applies at every adult infusion; the pediatric 10 mg/kg dose is the only JW case (a 20 kg child draws 200 mg from two vials with 60 mg discarded). The billing-units calculator walks through that same vial math dose by dose.

Full unit, vial and modifier math for any dose: calculate Stelara billing units →

Claim form

CMS-1500 / 837P field map for a separately payable J3358 line.

Stelara coverage

The Clearance corpus carries 29 payers and 502 rules for ustekinumab. Both indications are covered widely: a Crohn's disease and an ulcerative colitis rule set exist at all 29 payers.

• 29 of 29 commercial payer policy sets require prior authorization
• 17 name a preferred ustekinumab product
• 27 of 29 payers require another product first — usually a conventional therapy trial, and increasingly a specific preferred ustekinumab product rather than a TNF inhibitor.
• 11 rules set site-of-care requirements at 11 payers.
• 18 rules set a reauthorization period, most commonly 12 months; the IV induction itself is authorized only once, and it is the SC maintenance dose that gets renewed.
• 20 rules prohibit combining ustekinumab with another biologic or a JAK inhibitor.

Prior authorization, step therapy and reauthorization

Most payers require a conventional therapy trial first: BCBS Florida's Crohn's disease criteria require “inadequate response to ONE conventional agent (i.e., 6- mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD after at least a 3-month duration”, and BCBS Kansas requires “Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month* trial of corticosteroids or immunomodulators (e.g., azathioprine, 6- mercaptopurine, or methotrexate)” for the same indication.

Once conventional therapy fails, several payers steer toward a specific ustekinumab product rather than a TNF inhibitor. BCBS Arkansas requires that the “Initial request must be for a preferred product. If initial request is not a preferred product, an administrative denial will be issued,” naming “Select products (e.g., Pyzchiva SC/IV, Selarsdi, and Yesintek SC/IV)” as preferred.

BCBS Michigan lists “Preferred ustekinumab products: Yesintek IV”, BCBS Mississippi states “Selarsdi, Steqeyma, and Yesintek are the ustekinumab formulary options effective 08/01/2025,” and BCBS Minnesota names “Stelara, unbranded ustekinumab, Steqeyma, Yesintek, and Selarsdi” as the preferred products. CareFirst runs the opposite direction: its preferred list is “PREFERRED PRODUCTS: ENTYVIO, ILUMYA, REMICADE, SIMPONI ARIA, STELARA IV,” so brand Stelara clears without an extra step there.

Reauthorization governs the maintenance syringe more than the one-time infusion. BCBS Arkansas grants “INITIAL AND CONTINUATION APPROVAL will be for duration of the treatment course or 12 months (whichever comes first),” and BCBS Florida limits the first approval to “…1 month (to allow for one dose).” Cigna approves the induction dose for “30 days, which is an adequate duration” for the one-time infusion.

ICD-10-CM by indication

Two codes, one per diagnosis, both covered at all 29 payers in the corpus.

Site of care and quantity limits

Eleven rules restrict where the infusion can be given. HMHS calls ustekinumab “typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances,” and Blue Shield of California requires “ADMINISTRATION OF THIS DRUG IN THE HOSPITAL OUTPATIENT FACILITY SITE OF CARE.” Premera's rule turns on age instead: “For site of service for medical necessity the age described in this policy is 13 years of age or older.”

Fourteen rules set a quantity limit, and most restate the label's 520 mg top band, which is also the J3358 MUE. Anthem authorizes “4 vials (one time fill)” for a patient over 85 kg; BCBS Kansas and Capital Blue both cap the claim at “520 billable units (520 mg) x 1 dose”; Kaiser's reads “Max dose 520 mg.”

Check the patient’s actual policy: See Stelara coverage by payer →

Stelara cost & financial access

Medicare ASP+6%: $10.249 / 1 mg · $3,997.11 / 390 mg. Administration (96365) allows $67.14 more, so the induction claim allows $4,064.25 total; at 20% coinsurance with the Part B deductible met, the patient owes $812.85 ($799.42 drug plus $13.43 infusion).

1 induction infusion per course (one weight-banded IV dose, 390 mg for a 55 to 85 kg adult, then 90 mg subcutaneously every 8 weeks under J3357 or the pharmacy benefit) at $4,064.25 per infusion — drug plus 96365 administration — total $4,064.25 before the sequester. That is the full cost of the one-time induction infusion, drug plus administration, before benefits or assistance; the SC maintenance syringe that follows is billed separately and is not priced here, since J3357 is unpriced this quarter.

The other adult bands price on the same $10.249 per mg rate: 260 mg (two vials) allows $2,664.74 for the drug line, and 520 mg (four vials) allows $5,329.48; add $67.14 for 96365 at any band. A pediatric 10 mg/kg dose at 20 kg draws 200 mg ($2,049.80) from two vials, with 60 mg ($614.94) discarded on a JW line.

Commercial plans pay a contracted rate that varies by payer and state; 37 of 37 payer price files carry a J3358 rate. Aetna's all-states commercial median is $12.56 per unit, above the $10.249 ASP-based Medicare rate. At 390 units, that prices the drug portion at $4,898.40, against Medicare's $3,997.11.

The bigger swing is which ustekinumab product the claim uses. At the worked-example dose (390 units), the induction infusion prices from $886.47 for Wezlana ($2.273 per mg) to $5,165.94 for Otulfi ($13.246 per mg), against $3,997.11 for brand Stelara ($10.249 per mg) — and 17 of the 29 payers in the Clearance corpus name a preferred ustekinumab product, so the payer's own policy, not the prescriber's choice, often decides which of those eight codes the claim can carry (see Coverage & access).

Patient cost

Patient responsibility = payer allowed rate − benefits adjustment − assistance. Because J3358 is billed once, the estimate turns on the patient's weight band, plan, remaining deductible and assistance — not on which visit in a repeating schedule the encounter is.

Calculate a Stelara patient estimate →

Copay & financial assistance

Janssen CarePath Savings Program covers a commercially insured patient's drug cost at $5 per dose, up to $20,000 a year; it covers the drug only, not the infusion administration, and it excludes Medicare, Medicaid, TRICARE, VA and other government plans. The same program covers both the IV induction dose and the subcutaneous maintenance syringe. Verified April 8, 2026; 877-227-3728.

The Johnson & Johnson Patient Assistance Foundation, a free-drug program, closed as of June 14, 2026. Of the foundation funds in the bundle that match J3358, HealthWell's ANCA-associated vasculitis fund ($6,000 a year) treats a different disease, not Crohn's or ulcerative colitis; HealthWell's AutoImmune Medicare Access fund ($2,800/year) and TotalAssist's Ulcerative Colitis fund, formerly PAN ($3,000/year) could apply (check each fund's current status on the funds list). No open inflammatory bowel disease fund is on file.

See current Stelara assistance programs →

Common Stelara errors & fixes