CurrentCignaPolicy N/A

Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy

Defines prior authorization and medical necessity criteria for ustekinumab intravenous products for FDA‑approved indications (Crohn's disease and ulcerative colitis) and lists non‑covered indications and combination therapy exclusions for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevisions (product additions; criteria clarifications)

Effective Date

Next Review Date07/23/2025

Key ActionPrior Authorization is recommended for ustekinumab intravenous; approvals are provided for 30 days and medication must be prescribed by or in consultation with a physician who specializes in the condition being treated.

POLICY UPDATE CHANGES

Policy name was changed to more generally list Ustekinumab Intravenous Products; multiple branded IV products were added over 2024-2025 with same criteria applied.

Conditions Not Covered: concurrent use wording updated to 'Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug' (previously listed differently).

Ulcerative Colitis approval options removed in 07/23/2025 annual revision: removed earlier options including trial of one systemic therapy and pouchitis-related options.

2Covered Indications (FDA-approved)

4Not Medically Necessary scenarios

Approval duration (days)

Coverage Summary

Ustekinumab intravenous is an IL‑12/23 p40 subunit monoclonal antibody indicated as an IV induction therapy in adults (≥18 years) with moderate to severe active Crohn's disease and ulcerative colitis; following IV induction, maintenance therapy is recommended with subcutaneous ustekinumab (90 mg SC at week 8 after the IV dose, then every 8 weeks).

Scope: This policy defines prior authorization and medical necessity criteria for ustekinumab intravenous products for the FDA‑approved indications (Crohn's disease and ulcerative colitis), specifies documentation and approval duration (30 days to allow one IV dose), and lists non‑covered indications and combination therapy exclusions for Cigna‑administered health benefit plans.

Covered Indications (FDA-approved)2

Explicit Not Covered Conditions / Scenarios listed4

Approval duration (days)30

Medical Necessity / Approval Criteria

FDA-Approved Indication: Crohn's Disease (Approve single dose)

Approve a single dose if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

Patient is ≥ 18 years of age
The medication will be used as induction therapy
Patient meets ONE of the following
- Patient has tried or is currently taking a systemic corticosteroid, or a systemic corticosteroid is contraindicated in this patient
- Patient has tried one other conventional systemic therapy for Crohn's disease
  Examples include azathioprine, 6-mercaptopurine, or methotrexate; mesalamine does NOT count as a systemic agent for Crohn's disease
- Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas

FDA-Approved Indication: Ulcerative Colitis (Approve single dose)

Approve a single dose if the patient meets ALL of the following (A, B, and C):

ALL of the following

Patient is ≥ 18 years of age
The medication will be used as induction therapy
The medication is prescribed by or in consultation with a gastroenterologist
Approval requires prescription by or in consultation with a gastroenterologist

General Prior Authorization / Approval Duration

ALL of the following

Prior Authorization is recommended for prescription benefit coverage of ustekinumab intravenous
Approvals are provided for 30 days
30 days is considered adequate duration for the patient to receive one IV dose
Medication must be prescribed by or in consultation with a physician who specializes in the condition being treated

Not Medically Necessary / Exclusions

Ustekinumab intravenous is considered not medically necessary for ANY other use(s) including the following:

ANY of the following

Ankylosing Spondylitis (AS)
Insufficient data to demonstrate efficacy; other biologics indicated in AS
Concurrent use with a biologic or with a targeted synthetic oral small molecule drug used for an inflammatory condition
Combination therapy with another biologic or targeted synthetic oral small molecule drug is not allowed; does NOT exclude conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine)
Plaque Psoriasis (IV formulation)
Ustekinumab SC is indicated for plaque psoriasis; appropriate IV dosing is unclear

Coding

Listed Ustekinumab intravenous product names in policymixed

Stelara®	ustekinumab intravenous infusion - Janssen Biotech (brand name listed)
Imuldosa®	ustekinumab-srlf intravenous infusion - Accord
Otulfi™	ustekinumab-aauz intravenous infusion - Formycon/Fresenius
Pyzchiva™	ustekinumab-ttwe intravenous infusion - Sandoz/Samsung
Selarsdi™	ustekinumab-aekn intravenous infusion - Alvotech/Teva
Steqeyma™	ustekinumab-stba intravenous infusion - Celltrion
Wezlana™	ustekinumab-auub intravenous infusion - Amgen
Yesintek™	ustekinumab-kfce intravenous infusion - Biocon
Ustekinumab intravenous infusion (unbranded Stelara)	Ustekinumab intravenous infusion (Janssen Biotech / unbranded)
Ustekinumab-ttwe intravenous infusion (Quallent)	Ustekinumab-ttwe intravenous infusion (Quallent)

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for ustekinumab intravenous. Approvals are provided for 30 days, which is considered an adequate duration for the patient to receive one IV dose. Ustekinumab IV must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Approval duration: 30 days
PA applies to ustekinumab IV

Documentation Required

Documentation of prior therapies or contraindications

For Crohn's disease, document that the patient is ≥ 18 years of age, that ustekinumab IV will be used for induction therapy, and that one of the following applies: the patient has tried or is currently taking a systemic corticosteroid (or a systemic corticosteroid is contraindicated), OR the patient has tried one other conventional systemic therapy for Crohn's disease, OR the patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas, OR the patient had ileocolonic resection to reduce recurrence risk. Approval requires the medication to be prescribed by or in consultation with a gastroenterologist.

Background & Evidence

Clinical context: Ustekinumab IV targets the p40 subunit of interleukin‑12 and interleukin‑23 and is administered as a single weight‑based IV dose for induction in adults with moderate to severe Crohn's disease or ulcerative colitis.

Following IV induction, recommended maintenance is with the subcutaneous formulation; the policy distinguishes the IV role for induction from the SC role for ongoing maintenance.

Prior authorization and gastroenterologist involvement are required; approvals are issued for 30 days to permit administration of the single IV induction dose.

Guideline citationsACG 2025 and AGA 2024 guidelines referenced for Crohn's disease and ulcerative colitis management

Revision History

09/11/2024revised

Policy name was changed to more generally list Ustekinumab Intravenous Products; Wezlana IV was added and the same criteria applied.

12/18/2024revised

Otulfi, Pyzchiva, Selarsdi, Steqeyma, and Yesintek IV were added to the policy; the same criteria apply for all ustekinumab intravenous products.

01/29/2025revised

Ustekinumab-ttwe intravenous was added to the policy; the same criteria apply as the other ustekinumab intravenous products.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevisions (product additions; criteria clarifications)

Effective Date

Next Review Date07/23/2025

On This Page

Patient had ileocolonic resection (to reduce the chance of Crohn's disease recurrence)

The medication is prescribed by or in consultation with a gastroenterologist

Approval requires prescription by or consultation with a physician who specializes in the condition being treated

Psoriatic Arthritis (IV formulation)

Ustekinumab SC is indicated for psoriatic arthritis; appropriate IV dosing is unclear

Conventional systemic therapy (Crohn's disease): examples include azathioprine, 6‑mercaptopurine, or methotrexate; a trial of mesalamine does not count as a systemic agent for Crohn's disease.

Concomitant therapies excluded: Concurrent administration with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition is not allowed; this does not exclude use of conventional synthetic DMARDs (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine).

Note: approvals require the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (typically a gastroenterologist) and are provided for 30 days to allow one IV dose.

Examples of conventional systemic therapies: azathioprine, 6-mercaptopurine, methotrexate
A trial of mesalamine does NOT count as a systemic agent for Crohn's disease

Denial Risk

Claims for non-covered indications will be denied

Ustekinumab intravenous is considered not medically necessary for any other uses listed in the policy and claims billed for those non‑covered indications will be denied. Examples of non‑covered uses include ankylosing spondylitis, concurrent use with another biologic or with a targeted synthetic oral small molecule drug for an inflammatory condition, and use of IV dosing for plaque psoriasis or psoriatic arthritis where appropriate IV dosing is unclear.

Ankylosing Spondylitis (AS)
Concurrent use with a biologic or with a targeted synthetic oral small molecule drug
Plaque psoriasis (IV formulation)
Psoriatic arthritis (IV formulation)

02/19/2025revised

Ustekinumab intravenous (unbranded Stelara) was added to the policy; the same criteria apply as the other ustekinumab intravenous products.

04/23/2025revised

Imuldosa IV was added to the policy; the same criteria apply for all ustekinumab intravenous products.

06/25/2025revised

Policy name was changed to more generally list Ustekinumab Intravenous Products; multiple branded IV products were added over 2024-2025 with the same criteria applied.

09/11/2024revised

Conditions Not Covered: concurrent use wording updated to 'Concurrent use with a Biologic or with a Targeted Synthetic Oral Small Molecule Drug' (previously listed differently).

07/23/2025revisedLatest

Ulcerative Colitis criteria simplified: removed earlier approval options (trial of one systemic therapy and pouchitis-related options); UC approval now requires age ≥18, induction intent, and gastroenterologist prescription/consultation.