CurrentCignaPolicy PSM024

Ustekinumab Intravenous Products Preferred Specialty Management Policy

Defines Cigna's coverage and prior authorization framework that encourages use of preferred intravenous ustekinumab products for inflammatory bowel disease (Crohn's disease and ulcerative colitis) and describes exception rules for non-preferred products. Applies to health benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyUstekinumab Intravenous Products Preferred Specialty Management Policy

Policy CodePolicy PSM024

Change TypeNew policyrevised to add unbranded ustekinumab to Preferred

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document trials of all Preferred Products before requesting a Non-Preferred intravenous ustekinumab.

SourceLink

POLICY UPDATE CHANGES

New policy created for intravenous ustekinumab preferred products.

Ustekinumab intravenous (unbranded Stelara [Janssen]) was added to the policy as a Preferred product.

4Preferred products listed

3Non-preferred products listed

Prior authAuthorization mechanism

2Named indications

Policy Summary

PayerCigna

PolicyUstekinumab Intravenous Products Preferred Specialty Management Policy

Policy CodePolicy PSM024

Change TypeNew policyrevised to add unbranded ustekinumab to Preferred

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and document trials of all Preferred Products before requesting a Non-Preferred intravenous ustekinumab.

SourceLink

On This Page

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Initial coverage and non-preferred product exceptions

Preferred product pathway and non-preferred exception logic

Preferred product coverage: Patient meets the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy.

Applies to all intravenous ustekinumab products; approvals provided for durations specified in the standard prior authorization policy.

Non-Preferred product exception (Otulfi, Steqeyma): Approve when BOTH A and B are met: A) patient meets the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy; AND B) patient meets BOTH i and ii: i) patient has tried ALL preferred products (Stelara/ustekinumab, Selarsdi, ustekinumab-ttwe, and Yesintek) [documentation required]; AND ii) patient cannot continue ALL preferred medications due to formulation differences in inactive ingredients (e.g., stabilizing agent, buffering agent, surfactant) that, per the prescriber, would cause a significant allergy or serious adverse reaction [documentation required].

Documentation may include chart notes, prescription claims records, or prescription receipts; a trial of Pyzchiva counts toward a trial of ustekinumab-ttwe.

Pyzchiva handling: Pyzchiva IV is not approved; requests for Pyzchiva IV may be reviewed for the preferred ustekinumab-ttwe product using the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy criteria.

A trial of Pyzchiva may be counted toward an ustekinumab-ttwe trial when evaluating exception criteria.

Any request for a non-preferred intravenous ustekinumab product that does not meet the policy’s specified non-preferred product exception criteria is considered not medically necessary. The policy directs prescribers to the Preferred Product pathway and requires documentation when requesting review of non-preferred agents; only requests meeting the exception rules described below may be approved.

Specifically, Pyzchiva IV is not approved under this policy and is considered not medically necessary; requests for Pyzchiva IV may instead be reviewed as a request for the Preferred product ustekinumab-ttwe using the standard prior authorization criteria. Other non-preferred products (for example, Otulfi IV and Steqeyma IV) will only be approved when the patient meets the standard Inflammatory Conditions – Ustekinumab Intravenous Products Prior Authorization Policy and meets BOTH of the following: (i) documentation that the patient has tried ALL Preferred Products (Stelara/ustekinumab, Selarsdi, ustekinumab-ttwe, and Yesintek IV), and (ii) documentation from the prescriber that the patient cannot continue ALL Preferred medications because formulation differences in inactive ingredients would cause a significant allergy or serious adverse reaction.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

All intravenous ustekinumab products require prior authorization under the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy.

Prior authorization required for ALL IV ustekinumab products
Reviews follow the standard Inflammatory Conditions prior authorization criteria

Step Therapy

Try Preferred Products First

This program encourages use of Preferred Products. Patient must try ALL Preferred Products before approval of a Non-Preferred Product; requests for Non-Preferred Products are reviewed under the Non-Preferred Product Exception Criteria.

Patient must try ALL Preferred Products (Stelara IV/ustekinumab IV, Selarsdi IV, ustekinumab-ttwe IV, Yesintek IV) before a Non-Preferred Product will be approved
If standard prior authorization criteria are met but Preferred Products have not been tried, the request may be reviewed for Preferred Products using the standard Inflammatory Conditions prior authorization criteria

Documentation Required

Documentation of Prior Product Trials

When documentation of prior product trials is required, the prescriber must provide written documentation supporting trials of the other products. Documentation may include chart notes, prescription claims records, and/or prescription receipts.

Prescriber must supply written documentation of trials for required products when noted as [documentation required]
Acceptable documentation: chart notes, prescription claims, prescription receipts

Denial Risk

Denied When Billed with Non-Covered Codes

Claims submitted without covered diagnosis and/or procedure codes, or for conditions not covered under this policy, will be denied as not covered.

Submit services with the appropriate covered diagnosis/procedure codes in accordance with the applicable Coverage Policy
Claims for services not accompanied by covered codes will be denied

Step Therapy Details

Step	Requirement	Notes
1	Patient must try ALL Preferred Products (Stelara/ustekinumab IV; Selarsdi IV; ustekinumab-ttwe IV; Yesintek IV) before a Non-Preferred product will be approved.	Documentation of trials is required (e.g., chart notes, prescription claims records, receipts). A trial of Pyzchiva counts toward a trial of ustekinumab-ttwe.
Non-Preferred exception	Approve a Non-Preferred product (Otulfi IV or Steqeyma IV) only if BOTH A and B are met: A) patient meets the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy; AND B) i) patient has tried ALL Preferred Products (documentation required); AND ii) patient cannot continue ALL Preferred medications due to formulation differences in inactive ingredients causing a significant allergy or serious adverse reaction (documentation required).	If the patient meets standard prior authorization criteria but not the exception (B), the request may be reviewed for Preferred Products instead.
Pyzchiva handling	Pyzchiva IV is not approved; requests may be reviewed for the Preferred product ustekinumab-ttwe using the standard prior authorization criteria.	A trial of Pyzchiva counts towards a trial of ustekinumab-ttwe when evaluating exceptions.

Definitions

Biosimilar — definition

DefinitionBiosimilar: product with no clinically meaningful differences in safety and effectiveness and the same mechanism of action, route of administration, dosage form, and strength as the reference product (Stelara); minor differences in inactive components are allowed.

Reference productStelara (ustekinumab) — the reference biologic to which multiple ustekinumab products were approved as biosimilars.

Scope of samenessIncludes same mechanism of action, route of administration, dosage form, and strength.

Clinical impactNo clinically meaningful differences in safety and effectiveness compared with the reference product.

Permitted differencesMinor differences in clinically inactive components are allowed.

OpenPayer

Ustekinumab Intravenous Products Preferred Specialty Management Policy

Coverage Criteria

Provider Actions and Requirements

Initial Therapy / Step Requirements

Step Therapy Details

Site of Care

Background

Definitions

Biosimilar Information