ModifiedCignaPolicy IP0686

Ustekinumab Intravenous Products Prior Authorization Policy

Defines prior authorization, coverage criteria, dosing, and coding for intravenous ustekinumab products for inflammatory bowel disease (Crohn's disease and ulcerative colitis) for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyUstekinumab Intravenous Products Prior Authorization Policy

Policy CodePolicy IP0686

Change TypeMaterial updates — expanded product listcoding and criteria revisions

Effective Date03/15/2026

Next Review DateN/A

Key ActionObtain prior authorization and submit appropriate HCPCS/J-codes; approvals are provided for 30 days to permit one weight‑based IV induction dose.

SourceLink

POLICY UPDATE CHANGES

New policy created and expanded from Stelara-specific to include multiple ustekinumab intravenous products.

Note that Imuldosa intravenous (NDCs starting with 51407) and Wezlana intravenous are not covered on certain plan types.

Crohn's disease initial therapy approval options were removed (specific prior trial requirements were removed).

HCPCS/JCoding entries updated with multiple Q-codes and J3358 added.

2FDA indications

30 daysApproval duration

3Weight bands

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Coverage Criteria

Initial (Induction) Therapy - FDA Indications

Ustekinumab intravenous products are considered medically necessary when ONE of the following is met (1 or 2):

1. Crohn's Disease

A) Patient is ≥ 18 years of age;
B) The medication will be used as induction therapy;
C) The medication is prescribed by or in consultation with a gastroenterologist.
Dosing: Approve ONE weight-based IV dose: A) ≤55 kg: up to 260 mg; B) >55 to ≤85 kg: up to 390 mg; C) >85 kg: up to 520 mg.

2. Ulcerative Colitis

A) Patient is ≥ 18 years of age;
B) The medication will be used as induction therapy;
C) The medication is prescribed by or in consultation with a gastroenterologist.
Dosing: Approve ONE weight-based IV dose: A) ≤55 kg: up to 260 mg; B) >55 to ≤85 kg: up to 390 mg; C) >85 kg: up to 520 mg.

The policy specifies that use of ustekinumab intravenous products for indications other than the FDA‑approved inflammatory bowel disease induction indications is not medically necessary. Examples listed include ankylosing spondylitis (AS), plaque psoriasis (IV dosing unclear), and psoriatic arthritis (IV dosing unclear). Concurrent administration of ustekinumab IV with another biologic or a targeted synthetic oral small‑molecule therapy for an inflammatory condition is also not permitted under this policy.

The appendix provides product and mechanism summaries for multiple biologic and targeted therapies and lists examples of indications for each product. These appendix entries do not include additional explicit exclusions or separate "not medically necessary" statements beyond those in the main Conditions Not Covered section; they serve as reference material for drug classes, mechanisms of action, and example indications.

Policy language states that ustekinumab IV products for any use beyond the specified FDA‑approved Crohn's disease and ulcerative colitis induction indications are considered not medically necessary. The policy explicitly cites ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis as examples where IV dosing is unclear and therefore not covered, and it prohibits concurrent use with another biologic or a targeted synthetic oral small‑molecule drug for inflammatory conditions.

Initial (Induction) Therapy Criteria

Initial Therapy (Induction) — initial induction dosing and prescriber requirement

Crohn's Disease Induction: Patient ≥ 18; medication used as induction therapy; prescribed by or in consultation with a gastroenterologist; approve single weight-based IV dose per policy dosing bands.≤55 kg: up to 260 mg; >55 to ≤85 kg: up to 390 mg; >85 kg: up to 520 mg

Approval duration: 30 days to permit one dose.

Ulcerative Colitis Induction: Patient ≥ 18; medication used as induction therapy; prescribed by or in consultation with a gastroenterologist; approve single weight-based IV dose per policy dosing bands.≤55 kg: up to 260 mg; >55 to ≤85 kg: up to 390 mg; >85 kg: up to 520 mg

Approval duration: 30 days to permit one dose.

Maintenance and Continuation Criteria

Maintenance — maintenance strategy criteria for continuation of ustekinumab IV

Maintenance strategy

Maintenance: Following induction with IV ustekinumab, recommended maintenance is ustekinumab subcutaneous 90 mg given 8 weeks after the initial IV dose, then every 8 weeks thereafter.

Approvals may be extended if patient continues to meet criteria and dosing.

Coding and Dosing

Considered Medically Necessary HCPCS/J-codesHCPCSCovered

C9399	Unclassified drugs or biologicals.
J3358	Ustekinumab, for intravenous injection, 1 mg.
J3490	Unclassified drugs.
J3590	Unclassified biologicals.
Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg.
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg.
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg.
Q9997	Injection, ustekinumab-ttwe (Pyzchiva), intravenous, 1 mg.
Q9998	Injection, ustekinumab-aekn (Selarsdi), 1 mg.
Q9999	Injection, ustekinumab-aauz (Otulfi), biosimilar, 1 mg.

inv-06: Weight-based IV dosing — adult weight bands and corresponding mg limits

≤55 kg (≤121 lbs)Approve up to 260 mg as an intravenous infusion.

>55 kg to ≤85 kg (>121 to ≤187 lbs)Approve up to 390 mg as an intravenous infusion.

>85 kg (>187 lbs)Approve up to 520 mg as an intravenous infusion.

inv-16: USTEKINUMAB IV dosing — intravenous induction dosing summary

PurposeUsed as induction therapy followed by subcutaneous maintenance (90 mg SC at 8 weeks then every 8 weeks).

Prescriber requirementMedication must be prescribed by or in consultation with a gastroenterologist for CD or UC induction dosing.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of ustekinumab intravenous. Approval is granted only when the request meets the Criteria and Dosing in this policy. All approvals are provided for 30 days (sufficient for one dose). Requests for doses outside the dosing documented in this policy will be reviewed on a case‑by‑case basis by a clinician (Medical Director or Pharmacist).

Prior authorization required for coverage of ustekinumab intravenous (see Criteria and Dosing sections).
Approvals provided for 30 days; extended approvals allowed if patient continues to meet Criteria and Dosing.
Non‑standard dosing requests reviewed case‑by‑case by clinician.

Denial Risk

Coding and Criteria Compliance Required for Reimbursement

Claims must be billed with covered diagnosis and/or procedure codes consistent with this Coverage Policy. Reimbursement will not be provided for services billed for conditions or diagnoses not covered by this policy. Providers must use the most appropriate codes as of the submission effective date. Claims submitted without covered codes under this policy will be denied as not covered.

Step Therapy / Product Selection

Step	Requirement	Notes / Reference
1	Use preferred ustekinumab intravenous products before non-preferred ustekinumab intravenous products.	Refer to the Inflammatory Conditions - Ustekinumab Intravenous Products Preferred Specialty Management Policy for preferred product sequencing and exceptions.

Quantity Limits

inv-21: ustekinumab IV — single dose per approval (up to weight-based mg specified)

Quantity limit per approvalSingle IV dose per approval — weight-based maximum per band (≤55 kg: up to 260 mg; >55–≤85 kg: up to 390 mg; >85 kg: up to 520 mg).

Approval durationApprovals are provided for 30 days to permit one IV dose.

Site of Care

Note

Site of care not specified in this policy section

Site of care requirements are not specified in this section of the policy; follow the coverage policy and payer plan documents for any site-specific billing or coverage rules.

Refer to the customer's benefit plan document for details of covered products and site restrictions.

Biosimilars and Related Products

Billing Rule

Use preferred ustekinumab IV products before non-preferred

The policy requires use of preferred ustekinumab IV products before non-preferred products per the Preferred Specialty Management Policy; when billing or requesting authorization, ensure the preferred product sequencing is followed.

Preferred biosimilar and branded IV products are listed in the policy coding section (see HCPCS/Q-codes).
Exceptions and sequencing rules are in the separate Preferred Specialty Management Policy.

Background

Ustekinumab intravenous is a monoclonal antibody that targets the p40 subunit of interleukin‑12 and interleukin‑23. The policy identifies IV ustekinumab as indicated for induction therapy in adults with moderate to severe Crohn's disease and moderate to severe ulcerative colitis, with a single weight‑based IV induction dose followed by subcutaneous maintenance dosing.