CurrentCareSourcePolicy N/A

Ustekinumab Intravenous Products — Induction Coverage Criteria (Crohn's disease and Ulcerative Colitis)

This policy governs prior authorization and medical benefit coverage for intravenous ustekinumab products (induction dosing) for adults with Crohn's disease or ulcerative colitis and identifies conditions not recommended for approval. It applies to CareSource-managed members in North Carolina.

Policy Summary

PayerCareSource

PolicyUstekinumab Intravenous Products — Induction Coverage Criteria (Crohn's disease and Ulcerative Colitis)

Policy CodePolicy N/A

Change TypeProduct additions and clarification of exclusions

Effective DateN/A

Next Review DateJul 24, 2024

Key ActionObtain prior authorization to approve a single IV induction dose when all indication-specific criteria, required prior therapies, prescriber specialty, and weight-based dosing limits are met.

SourceLink

POLICY UPDATE CHANGES

Multiple additional ustekinumab intravenous products (biosimilars and alternatives) were added to the policy so the same criteria apply to all listed ustekinumab IV products.

Concurrent use with another biologic or a targeted synthetic oral small molecule is not recommended.

A note was added that a trial of a mesalamine product does not count as a systemic agent for ulcerative colitis.

2FDA-approved indications covered (CD and UC)

30 daysTypical approval duration (single IV induction)

MultipleUstekinumab IV products listed

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Coverage Criteria for IV Ustekinumab (Induction)

FDA-Approved Indications - Induction criteria and dosing

Coverage of ustekinumab intravenous is recommended when ALL of the following for the indicated diagnosis are met:

Crohn's disease induction (approve single dose)

ONE of the following (i–iv)
- Patient has tried or is currently on a systemic corticosteroid, or systemic corticosteroid is contraindicated. (Examples: prednisone, methylprednisolone).
- Patient has tried one other conventional systemic therapy for Crohn's disease (examples: azathioprine, 6-mercaptopurine, methotrexate).
- Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas.
- Patient had ileocolonic resection to reduce the chance of Crohn's disease recurrence.
An exception to the requirement for trial of or contraindication to steroids or trial of one other conventional systemic agent can be made if the patient has already tried at least one biologic other than the requested medication; a biosimilar of the requested biologic does not count.
Exception

Ulcerative colitis induction (approve single dose)

ONE of the following (i–ii)
- Patient has tried one systemic therapy (examples include systemic corticosteroids such as prednisone or methylprednisolone). Note: a trial of a mesalamine product does not count as a systemic therapy for ulcerative colitis. A trial of one biologic other than the requested medication also counts as a trial of one systemic agent; a biosimilar of the requested biologic does not count.
- Pouchitis pathway: Patient has pouchitis; AND patient has tried an antibiotic, probiotic, corticosteroid enema, or mesalamine enema (both a and b required per policy wording). (Examples of antibiotics include metronidazole and ciprofloxacin; examples of corticosteroid enemas include hydrocortisone enema).

Dosing options for induction

For patients <= 55 kg: approve up to 260 mg IV.
For mid-weight category (approve up to 390 mg IV).
For patients >= 85 kg: approve up to 520 mg IV.

Coverage of ustekinumab intravenous is not recommended for indications outside the policy’s FDA‑approved inflammatory bowel disease uses. Examples explicitly listed include ankylosing spondylitis, plaque psoriasis, and psoriatic arthritis, where appropriate IV dosing or evidence for the IV formulation is unclear and other therapies are available. The policy states that coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria and will be updated as new data become available.

The policy states that concurrent administration of ustekinumab IV with another biologic or with a targeted synthetic oral small molecule for an inflammatory condition is not recommended. Combination use is discouraged because of a potentially higher rate of adverse events and a lack of controlled data demonstrating additive benefit; conventional immunomodulators (e.g., methotrexate, azathioprine, 6‑mercaptopurine, sulfasalazine) are not excluded by this statement.

Use of ustekinumab IV in combination with another biologic or a targeted synthetic oral small molecule is considered not recommended and may be treated as not medically necessary. The policy clarifies that combination therapy is generally not advised due to safety concerns and insufficient controlled clinical evidence to support additive efficacy; the exclusion does not apply to standard conventional agents used in combination with ustekinumab.

Product Listings, Dosing Categories, and Codes

Ustekinumab Intravenous Products (neutral)mixed

Not specified

Product listing — specific billing codes not provided in source. Products include Stelara (ustekinumab), Otulfil (ustekinumab-aauz), ustekinumab-ttwe, Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-aekn), Wezlana (ustekinumab-auub), Steqeyma (ustekinumab-stba), Yesintek (ustekinumab-kfce)

Dosing Categories

Weight-based Dosing Categories• For patients ≤55 kg (≤121 lbs): Approve up to 260 mg as an intravenous infusion. • For patients 55–85 kg (122–187 lbs): Approve up to 390 mg as an intravenous infusion. • For patients >85 kg (>187 lbs): Approve up to 520 mg as an intravenous infusion. Note: Dosing presented as weight-based induction dosing categories consistent with FDA‑approved indications. Specific clinical scenarios (e.g., ulcerative colitis induction) may reference a single-dose approval when all clinical criteria are met.

Prior Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: A prior authorization is required for ustekinumab intravenous. Approvals are typically for a single IV induction dose (30 days) when all indication-specific criteria and dosing are met. Requests for doses outside the dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).

Approve a single IV induction dose when ALL indication criteria and weight-based dosing are met
Requests for non-standard doses reviewed by clinician case-by-case

Documentation Required

Required Prescriber and Documentation

Required Prescriber and Clinical Documentation: Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with ustekinumab intravenous, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., gastroenterologist for Crohn's disease or ulcerative colitis). Provide clinical documentation to support: patient age, indication, that the medication will be used as induction therapy, prior therapy trials or contraindications (including specifics of conventional systemic agents or biologics tried), presence of disease features that meet criteria (e.g., fistulas, prior ileocolonic resection, pouchitis), and weight for dosing.

Clinical Background

Ustekinumab is a monoclonal antibody that targets the p40 subunit shared by interleukin‑12 and interleukin‑23. In the context of inflammatory bowel disease, IV ustekinumab is used as a single weight‑based induction infusion for adults with moderate to severe Crohn’s disease or ulcerative colitis, followed by subcutaneous maintenance dosing per product labeling. The policy specifies weight‑based induction dose caps (for example, up to 260 mg for the lowest weight category, up to 390 mg mid‑range, and up to 520 mg for the highest weight category) and requires prior authorization for the single IV induction dose.

Key Definitions

Induction therapy

Single IV dose useInduction consists of one weight-based IV infusion followed by subcutaneous maintenance per product labeling

Adult populationInduction dosing criteria apply to adults (≥18 years) with moderate to severe disease