CareCost Prior authorization
Required
Check what the payer requires before you schedule Stelara.
29 payers, 502 rules, and 17 of them name a preferred ustekinumab product.
29 payer policy sets hold a ustekinumab policy · source-linked · reviewed August 2026
Aetna + Crohn’s disease is shown as a live example until you choose a payer.
This payer requires an approval on file before Stelara is purchased or infused for this member.
Precertification of ustekinumab products is required of all Aetna participating providers and members in applicable plan designs.
Covered under ICD-10 K50.
For treatment of moderately to severely active CD
What opens in CareCost
Aetna · Stelara · Crohn’s disease
For every requirement: the exact payer criteria, the source citation, a check-off, and a save to the patient’s chart.
In CareCost: check off each requirement · save to the patient · print for the chart
Aetna · Stelara · Crohn’s disease
You have already checked the policy, indication and covered dose. Open the remaining requirements and work them as a patient checklist.
CareCost tracks Stelara coverage requirements across 29 payer policy sets.
Aetna · Anthem / Elevance · Cigna · UnitedHealthcare · Kaiser Permanente WA · CareFirst BCBS · BCBS plans + more
Coverage clearance is only the first step.
CareCost carries the same patient through the entire workflow.
Finish this patient’s estimate →29 of 29 payers with a ustekinumab policy require prior authorization. Every payer in this corpus covers both ulcerative colitis and Crohn’s disease; what separates them is what has to happen before Stelara IV, not whether the diagnosis is covered. Step therapy, the preferred-product step, reauthorization timing and site-of-care rules vary by plan.
The 502 rules break out as 246 clinical prerequisites, 60 covered-indication rules (Stelara carries two ICD-10 families, each its own clearance key, each held by all 29 payers), 30 prior-authorization rules, 28 dosing rules, 26 step-external rules, 20 combination rules, 18 reauthorization rules, 18 billing-and-coding rules, 17 preferred-product rules, 14 quantity-limit rules, 14 contraindication exclusions and 11 site-of-care rules.
29 require PA · 29 have clinical criteria · 11 restrict site of care
All 29 of the payers CareCost has read require an approval on file before ustekinumab IV is covered. BCBS South Carolina’s step rule reads plainly: “Coverage of Ustekinumab is provided when the criteria below are met and there has been a trial and failure of preferred therapy (if applicable).” Every payer in this corpus works through that same clinical documentation before the induction infusion is paid.
Before Stelara IV is authorized, nearly every payer wants to see corticosteroids, immunomodulators or aminosalicylates tried and documented as ineffective, not tolerated or contraindicated. Florida Blue, for Crohn’s disease: “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.” BCBS Kansas asks for “a minimum 3-month* trial of corticosteroids or immunomodulators (e.g., azathioprine, 6- mercaptopurine, or methotrexate)” for Crohn’s disease, and a trial of “aminosalicylates, corticosteroids or immunomodulators” for ulcerative colitis. Arkansas BCBS documents the same idea more generally: “documented inadequate response (trial of greater than or equal to 3 months) to at least one conventional therapy option.”
17 of the 29 payers in this corpus name a specific ustekinumab product that has to be tried, or used, before the claim can carry a different one. BCBS Michigan: “Preferred ustekinumab products: Yesintek IV.” BCBS Mississippi: “Selarsdi, Steqeyma, and Yesintek are the ustekinumab formulary options effective 08/01/2025.” BCBS Nebraska routes the request through its own step numbering: “Formulary Preferred ustekinumab product (step 1a) Non-preferred ustekinumab product (step 3c) PDL10 Steqeyma, Yesintek, Selarsdi, Brand Stelara.” Arkansas BCBS is the strictest about sequencing: “Initial request must be for a preferred product. If initial request is not a preferred product, an administrative denial will be issued.” Two payers keep brand Stelara IV itself on the preferred list rather than routing around it — CareFirst: “PREFERRED PRODUCTS: ENTYVIO, ILUMYA, REMICADE, SIMPONI ARIA, STELARA IV”; BCBS Minnesota: “Stelara, unbranded ustekinumab, Steqeyma, Yesintek, and Selarsdi are the preferred ustekinumab products.” BCBS Louisiana instead moved brand Stelara out of the preferred column: “Moved Stelara to the section of the policy where the preferred ustekinumab alternatives must be tried and failed.”
Every IV dose ceiling in this corpus matches the label’s top band, because the drug is billed only once per course; the remaining limits describe the 90 mg subcutaneous maintenance syringe. Anthem: “Body weight more than 85 kg [max limit]: 4 vials (one time fill).” BCBS Kansas and Capital BlueCross both cap the top figure the same way: “520 billable units (520 mg) x 1 dose.” Kaiser writes it as a ceiling: “Quantity Limit: Max dose 520 mg.” The J3358 MUE is 520 units a day, matching the four-vial, over-85-kg band, with no allowance for a second infusion.
Florida Blue’s window is barely longer than the appointment itself: “CD, immune checkpoint inhibitor-related adverse effects, and UC - 1 month (to allow for one dose).” Cigna: “All approvals are provided for 30 days, which is an adequate duration…” BCBS HCSC shortens Crohn’s disease alone: 12 months for all indications except Crohn’s disease, 14 weeks. Once the patient moves to the subcutaneous maintenance syringe, renewal settles into an annual cycle: Arkansas BCBS grants “INITIAL AND CONTINUATION APPROVAL… for duration of the treatment course or 12 months (whichever comes first),” and BCBS Tennessee grants 12 months to members “using the requested medication for moderately to severely active ulcerative colitis and who achieve or maintain remission.”
11 of the 29 payers in this corpus set a location rule. Highmark BCBS treats it as strictly outpatient: “Ustekinumab (Stelara) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances.” Blue Shield of California specifies the opposite constraint: “ADMINISTRATION OF THIS DRUG IN THE HOSPITAL OUTPATIENT FACILITY SITE OF CARE,” keeping the dose inside a hospital outpatient department rather than a freestanding center. BCBS South Carolina allows either: the drug “may only be authorized to be administered in certain locations (sites of care), such as an infusion center or the patient’s home.” HCSC, BCBS Michigan and Cigna list J3358 in a site-of-care table; Excellus, Horizon, Regence and UHC point to a separate site-of-care policy rather than writing the restriction into the ustekinumab policy itself; Premera’s rule is an age threshold.
20 rules in this corpus bar Stelara alongside a second biologic. Arkansas BCBS spells out the list: “Individual is not using the medication in combination with any other biologic, including but not limited to: TNF inhibitor, IL-36 inhibitor, PDE4 inhibitor, any other IL inhibitor, or Janus kinase inhibitor.” BCBS Louisiana names specific products instead of drug classes: the requested drug must not be “used concurrently with other biologic products such as infliximab (Remicade, biosimilars), adalimumab (Humira, biosimilars), or vedolizumab.” BCBS Federal Employee Program folds a vaccine-timing rule into the same category: for Crohn’s disease, Stelara is “NOT given concurrently with live vaccines,” matching the label’s own caution against live vaccines during treatment. The combination rule governs concurrent use, not sequence — a patient can fail a TNF inhibitor and move to Stelara, but cannot run both at once.
14 rules name a specific reason Stelara IV cannot be started. BCBS Federal Employee Program: “Do not administer Stelara or its biosimilars to patients with active tuberculosis.” Florida Blue: “Do not start the ustekinumab product during any clinically important active infection.” Centene states the label’s own contraindication directly: “Clinically significant hypersensitivity to ustekinumab products or any of the excipients.” Highmark BCBS treats any other indication, or use alongside another biologic disease-modifying drug, as not medically necessary rather than as a formal contraindication.
Ustekinumab is an interleukin-12 and -23 antagonist, and the step-therapy question at most payers in this corpus is which ustekinumab product goes on the claim, not whether a different drug class is required first.
| Product | Code | Maker | Role in this corpus |
|---|---|---|---|
| Stelara (IV) | J3358 | Janssen (Johnson & Johnson) | This page |
| Yesintek (IV) | Q5100 | Biocon Biologics | Preferred product at BCBS Michigan, Mississippi, Nebraska and Minnesota; a required step at Independence and Highmark |
| Selarsdi | Q9998 | Teva | Preferred product at BCBS Mississippi, Nebraska, Minnesota and Arkansas |
| Steqeyma (IV) | Q5099 | Celltrion | Preferred product at BCBS Mississippi, Nebraska and Minnesota |
| Pyzchiva (IV) | Q9997 | Sandoz | Preferred product at BCBS Arkansas |
| Otulfi | Q9999 | Fresenius Kabi | Preferred product at Wellmark, which excludes Stelara from coverage otherwise |
| Wezlana (IV) | Q5138 | Amgen | One of four products UnitedHealthcare accepts in place of a non-preferred request |
| Imuldosa | Q5098 | Accord BioPharma | Non-preferred at some payers; BCBS Louisiana lists it among the products to use first in step-therapy tables |
CareCost reads 29 payer policies for ustekinumab. 17 of them name a specific preferred product, and 26 step-external rules route the request among these eight codes. Independence Blue Cross states the logic directly, calling Yesintek the preferred product, “less costly and at least as likely to produce equivalent therapeutic results as the nonpreferred…” UnitedHealthcare’s rule reads: “…non-preferred ustekinumab product will be required to change therapy to Starjemza, Steqeyma, Wezlana, or Yesintek.” Kaiser is the most demanding: for Crohn’s disease it wants failure of “≥ 2 TNF Inhibitors” and of “Two Ustekinumab biosimilars” before it will approve brand Stelara. Aetna’s non-preferred pathway reaches outside the ustekinumab family: for Crohn’s disease it wants a contraindication, intolerance or ineffective response to “all of the following available equivalent alternative targeted immune modulators (one-month trial each): Entyvio, Skyrizi…” and the rule, the same for Crohn’s disease and ulcerative colitis, applies only to a non-preferred ustekinumab product: one-month trials of Entyvio, Skyrizi, Pyzchiva or Stelara, Tremfya and an infliximab product.
Every payer in this corpus that covers Stelara still requires the covered-indication documentation below regardless of which product ends up on the claim; the preferred-product requirement decides the code, not whether ustekinumab is appropriate.
Ulcerative colitis and Crohn’s disease are billed under separate ICD-10 families in Stelara’s manifest, and all 29 payers in this corpus cover both. Each carries its own clearance key — ulcerative_colitis and crohns_disease — and a payer’s step-therapy language can differ between the two: Aetna’s non-preferred-product trial names the same alternatives for both, with Stelara itself among them.
| Indication | ICD-10 | Notes |
|---|---|---|
| Ulcerative colitis, moderately to severely active | K51.90 | Billable code; dxKey ulcerative_colitis, 29 of 29 payers |
| Crohn’s disease, moderately to severely active | K50.90 | Billable code; dxKey crohns_disease, 29 of 29 payers |
CareCost’s diagnosis picker above offers both. Verified against the NLM Clinical Table Search Service on 2026-09-21.
Medicare Part B covers Stelara IV as a physician-administered biologic under standard medical-necessity review: no coverage-with-evidence-development framework and no patient registry attaches to ustekinumab. This is the Original Medicare answer. Medicare Advantage plans deliver that same Part B benefit but are free to impose utilization-management steps of their own, such as a separate prior-authorization request or a site-of-care restriction. Confirm the specific plan’s rules directly, rather than presuming Original Medicare’s terms carry over.
Stelara IV is infused over at least one hour and billed with 96365 (therapeutic infusion, initial hour) alone, non-facility PFS $67.14; 96366 (each additional hour) applies only if the drip actually runs past 90 minutes, and 96413 (chemotherapy administration) is the wrong code family for an interleukin-12 and -23 antagonist. The J3358 MUE is 520 units per day, matching the top weight band — the four-vial, over-85-kg dose — with no waste and no room for a second infusion on the same claim.
Payer citation language above is drawn from CareCost’s own ustekinumab policy corpus (29 payers, 502 rules). Check the specific payer’s language →
It depends on the payer and plan. All 29 of the ustekinumab policies CareCost has read require prior authorization before Stelara IV is covered. Check this patient’s payer →
Almost always a conventional agent first: a documented three-month trial of corticosteroids, immunomodulators such as azathioprine or 6-mercaptopurine, or aminosalicylates, tried and failed, not tolerated or contraindicated. From there, 17 of 29 payers add a preferred-product step: the claim has to carry a named ustekinumab product, often Yesintek, Selarsdi or Steqeyma, before brand Stelara IV is approved, and Arkansas BCBS issues an administrative denial when the initial request is not for a preferred product. Check this patient’s payer →
It varies by payer, and the induction infusion is authorized separately from the subcutaneous maintenance dose that follows it. Florida Blue approves the infusion for one month, to allow for one dose, and Cigna’s approvals run for 30 days. BCBS HCSC renews most indications for 12 months but sets Crohn’s disease at 14 weeks. Once maintenance starts, most payers settle into a 12-month renewal cycle. Check this patient’s payer →
Yes, under Part B when the diagnosis and dosing match the FDA label; ustekinumab carries no national registry or evidence-development requirement. A Medicare Advantage plan is still bound by that Part B benefit design, but it can attach its own prior-authorization request or site restriction. See the Medicare detail →
Yes, at 11 of 29 payers. Highmark BCBS treats it as an outpatient procedure, covered as inpatient only in special circumstances. Blue Shield of California requires administration in the hospital outpatient facility site of care instead. Check this patient’s payer →
Data current: payer policies Aug 2026 · reviewed dates come from each payer
Payer medical and pharmacy policies · prior-authorization criteria · clinical coverage criteria. ICD-10 codes verified against the NLM Clinical Table Search Service. Medicare coverage and fee-schedule amounts from the CMS Medicare Coverage Database and the Medicare Physician Fee Schedule. Every CareCost requirement links back to its source policy.