CurrentCignaPolicy PSM022

Ustekinumab Subcutaneous Products Preferred Specialty Management Policy for Legacy Prescription Drug List Plans

Defines Cigna's preferred and non-preferred ustekinumab subcutaneous products, prior authorization and exception criteria for legacy prescription drug list plans; affects prescribers and pharmacists requesting pharmacy benefit coverage for ustekinumab products.

Policy Summary

PayerCigna

PolicyUstekinumab Subcutaneous Products Preferred Specialty Management Policy for Legacy Prescription Drug List Plans

Policy CodePolicy PSM022

Change TypeNew policy and product preference updates

Effective DateSep 1, 2025

Next Review Date

Key ActionPrescriber must document trials of all Preferred Products and reasons for inability to continue them when requesting approval for a Non-Preferred ustekinumab product.

SourceLink

POLICY UPDATE CHANGES

New policy created and effective 09/01/2025 covering ustekinumab subcutaneous products with a preferred products program.

Ustekinumab and ustekinumab-aekn were added as non-preferred subcutaneous products and directed to preferred equivalents.

Ustekinumab 45mg subcutaneous vial is covered as preferred on the medical benefit only; for pharmacy benefit refer to pharmacy criteria.

4Preferred ustekinumab subcutaneous products listed

6+Non-preferred ustekinumab and related products listed

Required

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Coverage Criteria for Ustekinumab Subcutaneous Products

Non-Preferred Product Exception Criteria

Applies when a non-preferred ustekinumab subcutaneous product is requested. Approve only when ALL of the following are met:

Exception approval requirements

Base prior authorization: Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria
See standard prior authorization policy
Preferred product trial and intolerance: Patient has tried ALL Preferred products (Stelara, Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous) and cannot continue ALL Preferred medications due to formulation differences in inactive ingredient(s) that, according to the prescriber, would result in a significant allergy or serious adverse reaction; documentation required
A trial of Pyzchiva counts toward ustekinumab-ttwe; a trial of ustekinumab counts toward Stelara; a trial of ustekinumab-aekn counts toward Selarsdi. Documentation may include chart notes, prescription claims records, or receipts.

Product-specific coverage stance

Directives and not-approved statements for specific ustekinumab products:

Product directives and not approved statements: Pyzchiva SC: Pyzchiva SC is not approved for coverage as a non-preferred product; a request for the Preferred product ustekinumab-ttwe may be reviewed. Ustekinumab SC (Janssen) 45mg vial: when requested under the prescription drug benefit, Ustekinumab SC is not approved; a request for the Preferred product Stelara may be reviewed. Ustekinumab-aekn SC: not approved; a request for the Preferred product Selarsdi may be reviewed.

Preferred and Non-Preferred product mapping and notes are in the Preferred and Non-Preferred Products table; the 45mg vial is preferred on the medical benefit only.

Any request for a non-preferred ustekinumab subcutaneous product that does not meet the listed exception requirements is considered not medically necessary. The policy directs use of Preferred Products (Stelara SC, Selarsdi SC, ustekinumab-ttwe SC, and Yesintek SC) and requires documentation when a Non-Preferred Product is requested. Specific Non-Preferred products (for example, Pyzchiva SC, Ustekinumab SC, and Ustekinumab-aekn SC) are either explicitly not approved under the prescription drug benefit or are directed to a Preferred equivalent; exceptions are only permitted when the Non-Preferred Product Exception Criteria are fully met.

Prescribers must provide written documentation supporting trials of all Preferred Products and the clinical reasons they cannot be continued. The policy requires that the patient has tried ALL Preferred products (Stelara, Selarsdi, ustekinumab-ttwe, and Yesintek) with supporting documentation (e.g., chart notes, prescription claims, receipts). If a Non-Preferred exception is requested, documentation must also show that the patient cannot use the Preferred options due to formulation differences in inactive ingredients that, per the prescriber, would cause a significant allergy or serious adverse reaction.

If the required documentation and trial history are not provided, or the exception criteria are not met (including failure to trial all Preferred Products), the request will be considered not medically necessary and may be denied. Additionally, a trial of Pyzchiva counts toward a trial of ustekinumab-ttwe; a trial of ustekinumab counts toward Stelara; and a trial of ustekinumab-aekn counts toward Selarsdi—document these trials as applicable.

Referenced Product Identifiers and Codes

Referenced product identifiersNDC

NDCs mentioned in Appendix (e.g., Humira starting with 00074)

Reference to specific NDC series for some non-ustekinumab preferred products

Provider Actions, Prior Authorization and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for all ustekinumab products. Members must meet the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy, including dosing criteria, for both Preferred and Non-Preferred products. Approvals follow the duration specified in the standard prior authorization policy. If the member meets the standard prior authorization criteria but has not tried Preferred Products, the request may be reviewed as a Preferred Product per the standard policy.

All ustekinumab products require prior authorization under the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy (includes dosing criteria).
Approvals are granted for the duration specified in the standard prior authorization policy.
If standard prior authorization criteria are met but Preferred Products have not been tried, a Preferred Product request may be reviewed under the standard prior authorization policy.

Step Therapy

Preferred-First Requirement

This program requires that the patient try ALL Preferred Products before a Non-Preferred Product will be approved. Requests for Non-Preferred Products are reviewed using the Non-Preferred Product Exception Criteria; any other exception is not medically necessary.

Background on Ustekinumab Subcutaneous Products

Ustekinumab subcutaneous products are indicated for multiple inflammatory conditions and include both branded products and biosimilars. Several ustekinumab products are approved as biosimilars to Stelara with no clinically meaningful differences in safety and effectiveness; however, inactive components may differ. The policy encourages use of Preferred Products (listed as Stelara SC, Selarsdi SC, ustekinumab-ttwe SC, and Yesintek SC) and establishes a preferred-first approach for coverage determination.

Key Definitions

Biosimilar — definition and scope

DefinitionBiosimilar: no clinically meaningful differences in safety and effectiveness compared with Stelara; same mechanism of action, route of administration, dosage form, and strength; minor differences in inactive components allowed.

Clinical implicationBiosimilars may be used as therapeutically equivalent alternatives to Stelara when policy permits, since safety and effectiveness are not meaningfully different.

Permitted differencesMinor variations in clinically inactive ingredients (formulation components) are acceptable and do not preclude biosimilarity.

ScopeApplies to multiple ustekinumab subcutaneous products approved as biosimilars to Stelara referenced in this policy.

Initial Therapy and Preferred-First Requirements

Initial therapy and preferred-first

Initial therapy approach — preferred-first requirement:

Initial: Patient must meet the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with dosing criteria and must try ALL Preferred Products prior to consideration of a Non-Preferred Product approval

Documentation of trials and reasons for inability to continue Preferred products is required; approvals follow durations in the standard prior authorization policy.

Step Therapy Requirements and Trials

Step	Requirement	Documentation
1
Patient must try ALL Preferred ustekinumab subcutaneous products (Stelara, Selarsdi, ustekinumab-ttwe, and Yesintek) prior to approval of a Non-Preferred ustekinumab subcutaneous product
Prescriber must provide written documentation supporting trials of all Preferred products (e.g., chart notes, prescription claims records, receipts).

Site of Care / Benefit Assignment

Note

45 mg ustekinumab vial covered as preferred on medical benefit only

Ustekinumab subcutaneous injection (Janssen Biotech) 45 mg vial is covered as a Preferred Product on the medical benefit only; pharmacy benefit coverage for the 45 mg vial follows the pharmacy criteria in this policy.

Biosimilar Guidance

Note

Policy encourages use of Preferred ustekinumab products (biosimilars and branded)

Several ustekinumab products are approved as biosimilars to Stelara and the program encourages use of Preferred Products, which include both the branded reference (Stelara) and preferred biosimilar options.

Preferred Products listed include Stelara SC, Selarsdi SC, ustekinumab-ttwe SC, and Yesintek SC.