CurrentCignaPolicy N/A

Inflammatory Conditions - Ustekinumab Subcutaneous Products Preferred Specialty Management Policy

Defines preferred versus non-preferred ustekinumab subcutaneous products, prior authorization and exception requirements, and directs trials of preferred products before non-preferred approvals for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Ustekinumab Subcutaneous Products Preferred Specialty Management Policy

Policy CodePolicy N/A

Change TypeMaterial updates to preferred/non-preferred listings and exception rules

Effective DateN/A

Next Review DateJan 15, 2025

Key ActionObtain prior authorization and document trials of all Preferred ustekinumab products and provide written evidence if inactive-ingredient differences prevent use.

SourceLink

POLICY UPDATE CHANGES

Selarsdi, ustekinumab-ttwe, and Yesintek were added to the policy as Preferred ustekinumab subcutaneous products.

Otulfi and Steqeyma were added to the policy as Non-Preferred ustekinumab subcutaneous products.

For the non-preferred products, the option of approval allowing continuation of therapy was removed.

5Preferred ustekinumab SC products

7Non-Preferred ustekinumab SC products

Trials & exception support

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Coverage Criteria for Ustekinumab Subcutaneous Products

Non-Preferred Product Exception Criteria

Non-Preferred products are covered as medically necessary only when the specified exception criteria are met.

Otulfi/Steqeyma/Wezlana exception: Approve if the patient meets BOTH of the following (A and B): A) Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria; AND B) Patient meets BOTH of the following (i and ii): i) Patient has tried ALL of Stelara, Imuldosa, Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous [documentation required]; AND ii) Patient cannot continue to use ALL Preferred medications (i.e., Stelara, Imuldosa, Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous) due to formulation differences in the inactive ingredient(s) (e.g., differences in stabilizing agent, buffering agent, and/or surfactant) which, according to the prescriber, would result in a significant allergy or serious adverse reaction [documentation required]. Note: A trial of Pyzchiva counts towards a trial of ustekinumab-ttwe; a trial of ustekinumab counts towards a trial of Stelara; a trial of ustekinumab-aekn counts towards a trial of Selarsdi.trial of all Preferred products; documented inactive-ingredient allergy/serious adverse reaction

If standard prior auth criteria met but exception B not met, approve Preferred Products instead.

Pyzchiva SC is not approved. Offer to review for ustekinumab-ttwe using the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria.not applicable

Directed to ustekinumab-ttwe

Ustekinumab (generic) and Ustekinumab-aekn: Ustekinumab SC is not approved; offer to review for Stelara using the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria. Ustekinumab-aekn SC is not approved; offer to review for Selarsdi using the standard Prior Authorization with Dosing criteria.not applicable

Directed substitutions to Preferred products

Preferred Product Coverage

Covered when ALL of the following are met

Preferred product authorization: Patient must meet the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria; if criteria met but Preferred Products have not been tried, approval will be for the Preferred Products. All approvals are provided for the duration noted in the standard prior authorization policy.standard prior auth criteria

If standard prior auth criteria met but Preferred Products not tried, approval will be for Preferred Products.

The policy distinguishes Preferred and Non-Preferred ustekinumab subcutaneous products. Preferred Products include Stelara SC, Imuldosa SC, Selarsdi SC, ustekinumab-ttwe SC, and Yesintek SC. Several Non-Preferred products are directed to a Preferred alternative and may be covered only when the policy’s exception criteria are met; examples include Otulfi SC, Steqeyma SC, and Wezlana SC (exception pathway described below), while products such as Pyzchiva SC, Ustekinumab SC, and Ustekinumab-aekn SC are not approved as non-preferred and are directed to specific Preferred alternatives (Pyzchiva → ustekinumab-ttwe; Ustekinumab → Stelara; Ustekinumab-aekn → Selarsdi).

Any exception request for a Non-Preferred ustekinumab product that does not meet the defined exception criteria will be considered not medically necessary. If the standard prior authorization criteria are met but the exception requirements (e.g., documented trials of all Preferred products and documented inability to continue Preferred products due to inactive-ingredient-related allergy or serious adverse reaction) are not satisfied, authorization will be for Preferred Products instead.

Product and Coding Listings

Ustekinumab (Janssen) - Branded / Reference ProductHCPCSCovered

J3357	Injection, ustekinumab, 1 mg (example HCPCS code for reference - verify payer-specific billing code)
Stelara	Stelara (ustekinumab) subcutaneous injection - Janssen Biotech (brand)

Ustekinumab Subcutaneous Products - Other Manufacturers / Biosimilarsmixed

Ustekinumab SC	Ustekinumab subcutaneous injection (Janssen Biotech) - non-preferred directed to Stelara SC per policy
Ustekinumab-aekn	Ustekinumab-aekn subcutaneous injection (Alvotech/Teva) - directed to Selarsdi SC
Ustekinumab-ttwe	Ustekinumab-ttwe subcutaneous injection (Quallent/Sandoz) - listed as preferred or directed product per policy
Ustekinumab-srlf	Ustekinumab-srlf subcutaneous injection (Accord BioPharma - Imuldosa)
Ustekinumab-aauz	Ustekinumab-aauz subcutaneous injection (Formycon/Fresenius - Otulfi)
Ustekinumab-ttwe (Pyzchiva)	Pyzchiva (ustekinumab-ttwe) subcutaneous injection (Sandoz/Samsung) - non-preferred directed to ustekinumab-ttwe SC
Ustekinumab-stba	Ustekinumab-stba subcutaneous injection (Celltrion - Steqeyma)
Ustekinumab-auub	Ustekinumab-auub subcutaneous injection (Amgen - Wezlana)
Ustekinumab-kfce	Ustekinumab-kfce subcutaneous injection (Biocon - Yesintek)

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required

All ustekinumab subcutaneous products (Preferred and Non-Preferred) require prior authorization and will be reviewed under the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing; approvals follow that policy's duration.

Step Therapy

Preferred-first step requirement

Patients must try all Preferred ustekinumab products (Stelara, Imuldosa, Selarsdi, ustekinumab-ttwe, and Yesintek) before a Non-Preferred ustekinumab product will be approved; if Preferred products have not been tried, approval will be for the Preferred Products.

Documentation Required

Trial and exception documentation required

Definitions

Biosimilar (definition and implications)

DefinitionBiosimilar: no clinically meaningful differences in safety and effectiveness and the same mechanism of action, route of administration, dosage form, and strength as Stelara.

Allowed differencesMinor differences in clinically inactive (inactive) components are permitted.

Clinical implicationBiosimilarity denotes therapeutically equivalent safety and effectiveness to the reference product (Stelara).

Regulatory basisApproval as a biosimilar reflects demonstration of no clinically meaningful differences from Stelara in key clinical measures.

Most actionableTreat biosimilar ustekinumab products as having equivalent safety and effectiveness to Stelara for coverage considerations; note that minor inactive-ingredient differences may exist and can be relevant only when a patient has a documented allergy or serious adverse reaction to those inactive components.

Background

Ustekinumab subcutaneous products are indicated for multiple inflammatory conditions and include both originator and biosimilar formulations. The policy treats biosimilars as clinically acceptable alternatives to the reference product for the purposes of required trials when explicitly noted (for example, trials of Pyzchiva count toward a trial of ustekinumab-ttwe; ustekinumab counts toward Stelara; ustekinumab-aekn counts toward Selarsdi). All ustekinumab products (Preferred and Non-Preferred) require prior authorization under the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing, and approvals follow that policy’s duration. For Non-Preferred products that may be considered via exception (e.g., Otulfi, Steqeyma, Wezlana), approval requires both meeting the standard prior authorization criteria and documentation of trials of ALL Preferred Products plus documentation that formulation differences in inactive ingredients would cause a significant allergy or serious adverse reaction and therefore prevent continued use of Preferred medications.