Currentculinary health fundPolicy N/A

Ustekinumab Intravenous Products Utilization Management

Defines prior authorization, approval criteria, dosing, and non‑coverage conditions for ustekinumab intravenous products used as induction therapy for adult Crohn's disease and ulcerative colitis; applies to medical benefit claims and prescribing clinicians (gastroenterologists).

Policy Summary

Payerculinary health fund

PolicyUstekinumab Intravenous Products Utilization Management

Policy CodePolicy N/A

Change TypeMultiple additions and revisions (material)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for a single weight‑based IV induction dose (30‑day approval) and document age, indication, prescriber specialty, and prior therapy per criteria.

SourceLink

POLICY UPDATE CHANGES

Multiple branded and biosimilar ustekinumab intravenous products (e.g., Otulfi, Pyzchiva, Selarsdi, Steqeyma, Yesintek, Starjemza, Wezlana, Imuldosa, Ustekinumab-ttwe, and unbranded ustekinumab IV) were added to the policy with the same criteria as Stelara IV.

Ulcerative colitis approval options were narrowed by removing prior options such as 'patient has tried one systemic therapy' and certain pouchitis-related trial requirements.

Conditions Not Recommended: concurrent use with another biologic or with a targeted synthetic oral small molecule drug clarified/updated.

Approval duration is provided for 30 days to allow administration of a single IV induction dose.

2FDA‑approved indications (CD and UC)

30 daysTypical approval duration

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multipleProducts listed

Coverage and Medical Necessity Criteria

Initial Therapy (Crohn's disease and Ulcerative Colitis)

Covered when ALL of the following are met for the respective indication

Crohn's disease - initial approval

A: Patient is ≥ 18 years of age
B: The medication will be used as induction therapy
C: Patient meets ONE of the following
Options: i. Tried or currently taking a systemic corticosteroid, or corticosteroid contraindicated; OR ii. Tried one other conventional systemic therapy for Crohn's disease (examples: azathioprine, 6-mercaptopurine, methotrexate; note: mesalamine does not count); OR iii. Has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR iv. Had ileocolonic resection.
D: Medication prescribed by or in consultation with a gastroenterologist
Dosing: Approve ONE weight-based dose: ≤ 55 kg up to 260 mg; >55–85 kg up to 390 mg; >85 kg up to 520 mg (single IV infusion)

Ulcerative colitis - initial approval

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

Coverage of ustekinumab intravenous is not recommended for certain indications where evidence, dosing, or approved IV regimens are lacking. Specifically, use is not recommended for ankylosing spondylitis given limited and inconclusive data; for plaque psoriasis and psoriatic arthritis because appropriate IV dosing is unclear; and for other circumstances not listed in the Recommended Authorization Criteria. Requests for these indications may be declined unless new published data or guidance supporting IV use become available.

Administration of ustekinumab IV in combination with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not recommended. Combination therapy is discouraged because of a potentially higher rate of adverse events and lack of controlled clinical data demonstrating additive benefit. This restriction does not apply to concurrent use of conventional agents (for example, methotrexate, 6-mercaptopurine, azathioprine, or sulfasalazine) when used per standard practice.

Dosing and Code-related Details

Weight-based dosing tiers

≤55 kg (≤121 lbs)Up to 260 mg (single IV infusion)

>55–85 kg (>121–≤187 lbs)Up to 390 mg (single IV infusion)

>85 kg (>187 lbs)Up to 520 mg (single IV infusion)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for ustekinumab intravenous. Approvals are provided for a single weight‑based induction dose and are granted for 30 days to allow administration of that dose. Ustekinumab intravenous must be prescribed by or in consultation with a gastroenterologist or a physician who specializes in the condition being treated.

All approvals: 30 days (one induction dose).
Prescriber: specialist in the treated condition; for Crohn's disease, prescriber or consult must be a gastroenterologist.

Step Therapy

Step Therapy for Crohn's Disease

For Crohn's disease, step-therapy requirements must be met before approval of ustekinumab intravenous for induction: the patient must be ≥18 years of age, the request is for induction therapy, and the prescriber is a gastroenterologist. In addition, the patient must meet ONE of the following step criteria: trial of systemic corticosteroid (or documented contraindication), trial of one other conventional systemic therapy (e.g., azathioprine, 6-mercaptopurine, methotrexate), presence of enterocutaneous or rectovaginal fistulas, or history of ileocolonic resection to reduce recurrence. An exception to the steroid/conventional agent requirement may be made if the patient has previously tried at least one biologic other than the requested medication (a biosimilar does not count). A trial of mesalamine does not satisfy the systemic agent requirement.

Clinical Background

Ustekinumab IV is an anti–IL-12/23 monoclonal antibody used as a single weight-based IV induction dose in adults with moderate-to-severe Crohn’s disease and ulcerative colitis, followed by subcutaneous maintenance dosing. The policy advises against IV use in certain conditions (see exclusions) where evidence or dosing guidance is insufficient, and it specifically discourages concurrent administration with other biologics or targeted synthetic oral small molecules due to safety and evidence concerns.

Key Definitions

Induction therapy (definition)

DefinitionInduction therapy is the initial IV single weight‑based dose of ustekinumab intended to induce remission prior to maintenance subcutaneous (SC) therapy.

AdministrationGiven as a single weight‑based IV infusion for Crohn's disease or ulcerative colitis.

Maintenance follow-upAfter IV induction, recommended maintenance is ustekinumab 90 mg SC administered 8 weeks after the initial IV dose, then every 8 weeks.

Policy Summary

Payerculinary health fund

PolicyUstekinumab Intravenous Products Utilization Management

Policy CodePolicy N/A

Change TypeMultiple additions and revisions (material)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for a single weight‑based IV induction dose (30‑day approval) and document age, indication, prescriber specialty, and prior therapy per criteria.

SourceLink

On This Page

Patient age: ≥ 18 years.
Induction therapy only.
ONE of: trial of systemic corticosteroid (or contraindication), trial of one other conventional systemic agent (azathioprine, 6‑mercaptopurine, methotrexate), enterocutaneous or rectovaginal fistulas, or prior ileocolonic resection.
Exception: prior trial of ≥1 other biologic (non‑biosimilar) may substitute for conventional agent/steroid trial.

Documentation Required

Required Clinical Documentation

Documentation must demonstrate the patient meets the Recommended Authorization Criteria: age ≥18, indication (Crohn's disease or ulcerative colitis where applicable), intent for induction therapy, specialty of prescribing clinician (gastroenterologist for Crohn's disease), and evidence supporting step‑therapy criteria or documented contraindications. Requests for dosing outside the dosing specified in the policy will be reviewed case‑by‑case by a clinician.

Show age, indication, and that use is for induction therapy.
Show prescriber specialty or consult (gastroenterologist for Crohn's disease).
Provide documentation of trials of therapies or contraindications per step‑therapy rules.
Requests for non‑standard dosing require clinician review.

Denial Risk

Triggers for Denial

Requests for indications not listed in the Recommended Authorization Criteria (for example ankylosing spondylitis, plaque psoriasis, psoriatic arthritis) or for concurrent use with another biologic/targeted synthetic oral small molecule are not recommended for approval. Combination use with other biologics or targeted synthetic oral small molecules is generally not allowed due to safety concerns and lack of supporting data.

Not recommended: ankylosing spondylitis, plaque psoriasis, psoriatic arthritis.
Not recommended: concurrent use with another biologic or targeted synthetic oral small molecule (does not exclude conventional immunomodulators such as methotrexate, azathioprine, 6‑mercaptopurine, sulfasalazine).
Coverage not recommended for circumstances outside the Recommended Authorization Criteria.