CurrentCareSourcePolicy N/A

Inflammatory Conditions Ustekinumab Intravenous Products Utilization Management Medical Policy

Defines prior authorization, coverage criteria, dosing, and exclusions for intravenous ustekinumab products for adults with Crohn's disease or ulcerative colitis; applies to medical benefit requests and prescribers (gastroenterologists) managing these indications.

Policy Summary

PayerCareSource

PolicyInflammatory Conditions Ustekinumab Intravenous Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeProduct additionsclarification on combination therapyprior therapy definition for UC

Effective DateN/A

Next Review DateJul 24, 2024

Key ActionObtain prior authorization for a single weight‑based IV induction dose and document age, indication, prior systemic therapy trials or contraindications, and patient weight.

SourceLink

POLICY UPDATE CHANGES

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

Concurrent use with a biologic or targeted synthetic oral small molecule was clarified/changed in the Conditions Not Recommended section.

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

2FDA‑approved indications covered (Crohn's disease, Ulcerative colitis)

30 daysTypical approval duration to allow one IV dose

Weight-basedDosing approach (three weight bands listed)

Concurrent biologic useExplicitly not recommended (combination therapy discouraged)

Coverage Criteria for Intravenous Ustekinumab

Initial therapy - Crohn's disease

Covered when ALL of the following are met:

Crohn's disease - overall

Prior therapy or clinical conditions (one required): Patient has tried or is currently on a systemic corticosteroid, or systemic corticosteroid is contraindicated; OR patient has tried one other conventional systemic therapy for Crohn's disease (examples include azathioprine, 6-mercaptopurine, or methotrexate); OR patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR patient had ileocolonic resection to reduce recurrence; OR exception: patient has already tried at least one biologic other than the requested medication (a biosimilar of the requested biologic does NOT count).
A trial of mesalamine does NOT count as a systemic agent for Crohn's disease.

Initial therapy - Ulcerative colitis

Covered when ALL of the following are met:

Ulcerative colitis - overall

Policy Summary

PayerCareSource

PolicyInflammatory Conditions Ustekinumab Intravenous Products Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeProduct additionsclarification on combination therapyprior therapy definition for UC

Effective DateN/A

Next Review DateJul 24, 2024

Key ActionObtain prior authorization for a single weight‑based IV induction dose and document age, indication, prior systemic therapy trials or contraindications, and patient weight.

SourceLink

On This Page

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Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for IV induction dosing of ustekinumab. Approvals are provided for a single weight-based IV induction dose for adults and are typically authorized for 30 days to allow administration of that dose. Requests for doses outside the dosing ranges documented in the policy will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist). Ustekinumab IV must be prescribed by or in consultation with a physician who specializes in the treated condition.

Approvals are for a single weight-based IV induction dose for adults.
Typical approval duration: 30 days to permit receipt of one dose.
Exceptions or doses outside policy dosing ranges require clinician review.

Documentation Required

Required Documentation for Prior Authorization

The provider must include specific documentation with the prior authorization request to support medical necessity. Incomplete documentation may result in denial or delay.

Patient age and weight.
Indication (e.g., Crohn's disease or ulcerative colitis) and statement that the IV ustekinumab is intended for induction therapy.
Clinical history demonstrating prior therapies tried, including dates and outcomes (e.g., trial of systemic corticosteroid, azathioprine, 6‑mercaptopurine, methotrexate, or prior biologics).
Documentation of reasons for contraindication or intolerance to required prior therapies when applicable.
Relevant surgical history when claimed (e.g., ileocolonic resection for Crohn's disease).
Confirmation that the medication is prescribed by or in consultation with a gastroenterologist (or other appropriate specialist).
Planned IV dose (weight-based) and rationale if requesting a dose different from policy-specified ranges.

Denial Risk

Combination Therapy Exclusion

Requests for concurrent use of ustekinumab intravenous with another biologic or with a targeted synthetic oral small molecule for an inflammatory condition are generally not recommended and may be denied.

Combination therapy (ustekinumab IV plus another biologic or targeted synthetic oral small molecule) is not recommended due to higher adverse event risk and lack of controlled data supporting added benefit.
This does not exclude use of conventional immunomodulatory agents (e.g., methotrexate, 6‑mercaptopurine, azathioprine, sulfasalazine) in combination with ustekinumab.
Refer to the policy appendix for examples of biologics and targeted synthetic oral small molecules.

OpenPayer

Inflammatory Conditions Ustekinumab Intravenous Products Utilization Management Medical Policy

Coverage Criteria for Intravenous Ustekinumab

Dosing Bands and Coding Notes

Provider Requirements and Authorization Actions

Definitions & Therapy Types

Background