CurrentCignaPolicy PSM021

Inflammatory Conditions - Ustekinumab Subcutaneous Products Preferred Specialty Management Policy for Standard/Performance, Value/Advantage, and Total Savings Prescription Drug Lists - (PSM021)

Defines preferred, non-preferred, and non-covered ustekinumab subcutaneous products across pharmacy and medical benefits, required prior authorization and exception criteria directing trials of preferred products, documentation requirements, and product-specific NDC prefixes and routing between pharmacy vs medical benefits.

Policy Summary

PayerCigna

PolicyInflammatory Conditions - Ustekinumab Subcutaneous Products Preferred Specialty Management Policy for Standard/Performance, Value/Advantage, and Total Savings Prescription Drug Lists - (PSM021)

Policy CodePolicy PSM021

Change TypeNew policy with multiple step changes and product routing updates

Effective DateMay 1, 2026

Next Review Date

Key ActionAll ustekinumab products require meeting the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria; provide written documentation of trials and adverse reaction rationale as required.

SourceLink

POLICY UPDATE CHANGES

New policy created.

Tremfya subcutaneous added to Appendix A as a Preferred Non-Ustekinumab Product for Crohn's disease.

Ustekinumab and Ustekinumab-aekn were added as Non-Preferred subcutaneous products; requests directed to Stelara and Selarsdi respectively (later harmonized into same exception criteria).

Imuldosa moved from Step 3 Non-Preferred to Step 1 Preferred (NDCs starting with 69448).

Certain products designated as Non-Covered for Employer Plans (Imuldosa NDCs 51407, Pyzchiva NDCs 83457, ustekinumab-aauz SC, Wezlana SC).

Ustekinumab SC 45mg vial is covered as preferred on the medical benefit only; pharmacy benefit coverage follows table.

Appendix A updated with Non-Ustekinumab Preferred Products including addition of Sotyktu for psoriatic arthritis.

Coverage Summary

This policy defines Preferred, Non-Preferred, and Non-Covered ustekinumab subcutaneous products across the pharmacy and medical benefits and directs that all products require the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria. The program encourages use of Preferred Products first and requires documented trials of preferred agents or meeting exception criteria before approving Non-Preferred products. The policy also identifies specific product routing between pharmacy and medical benefits (including the 45mg vial medical-benefit handling) and lists NDC prefix–specific rules for preferred and non-covered designations.

Key dates and status

Policy numberPSM021

StatusCURRENT

Effective date05/01/2026

Last review date05/01/2026

Next review date

Preferred and Non-Preferred Product Steps (Stepped Access)

Preferred Products (Step 1)NDC|mixedCovered

Imuldosa SC	NDCs starting with 69448 (Preferred Imuldosa NDC prefix)
Selarsdi SC	Selarsdi subcutaneous product
ustekinumab-ttwe SC	ustekinumab-ttwe subcutaneous
Yesintek SC	Yesintek subcutaneous

Step 2 Non-Preferred (directed to ONE Preferred)mixed

Stelara SC

Stelara subcutaneous (requests directed to one Preferred Product)

Step 3 Non-Preferred (directed to ALL Preferred)mixed

Otulfi SC	Otulfi subcutaneous (non-preferred)
Pyzchiva SC	Pyzchiva subcutaneous (NDCs starting with 61314) - non-preferred
Starjemza SC	Starjemza subcutaneous (non-preferred)
Steqeyma SC	Steqeyma subcutaneous (non-preferred)
ustekinumab SC	ustekinumab subcutaneous (Janssen Biotech) - non-preferred except 45mg vial special handling
ustekinumab-aekn SC	ustekinumab-aekn subcutaneous (non-preferred)

Non-Covered ProductsNDC|mixedNot Covered

Imuldosa SC	NDCs starting with 51407 (non-covered)
Pyzchiva SC	NDCs starting with 83457 (non-covered)
ustekinumab-aauz SC	ustekinumab-aauz subcutaneous (non-covered)
Wezlana SC	Wezlana subcutaneous (non-covered)

Products listed in policy header / covered options (neutral listing)mixed

Stelara	ustekinumab subcutaneous injection - Janssen Biotech (listed in header)
Imuldosa (Accord)	ustekinumab-srlf subcutaneous injection - Accord
Otulfi (Formycon/Fresenius)	ustekinumab-aauz etc.
Pyzchiva (Sandoz/Samsung, Cordavis)	listed
Selarsdi (Alvotech/Teva)	listed
Starjemza (BioThera)	listed
Steqeyma (Celltrion)	listed
ustekinumab-aauz	listed
ustekinumab-aekn	listed
ustekinumab-ttwe	listed

1–10 of 12

1/2

General Program and Prior Authorization

This program directs use of Preferred Products first; all products require meeting the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria.

ALL of the following

Patient must meet the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria
Patient directed to try Preferred Product(s) prior to approval of a Non-Preferred Product; Non-Preferred requests reviewed using exception criteria
Continuation of therapy for a patient currently taking Stelara is allowed (per standard prior authorization policy duration)

Non-Preferred Product Exception Criteria

Exception Criteria — Ustekinumab SC 45 mg Vial (Medical Benefit Only)

Billing Rule

Product routing between pharmacy and medical benefit

Ustekinumab 45 mg subcutaneous vial (Janssen Biotech) is covered as a preferred product on the medical benefit only. Pharmacy benefit coverage follows the product/NDC table and NDC-specific rules in the policy. Providers should route requests and billing accordingly (medical benefit for 45 mg vial; pharmacy per NDC).

45 mg vial: preferred on medical benefit only
Pharmacy coverage: follows product table and NDC-specific rules

Alternate Review Path When Exception Criteria Not Met

Appendix A - Other (Non-Ustekinumab) Preferred Products by IndicationmixedCovered

Adalimumab Products	includes adalimumab-adbm/Cyltezo, Simlandi/adalimumab-ryvk (-ryvk NDCs starting with 82009)
Enbrel	etanercept
Otezla/Otezla XR	apremilast
Skyrizi SC	risankizumab subcutaneous
Sotyktu	deucravacitinib tablets
Taltz	ixekizumab
Tremfya SC	guselkumab subcutaneous (added to Appendix A as Preferred for Crohn's)
Zymfentra	listed for Crohn's
Omvoh SC	listed for Crohn's/UC
Velsipity	listed for UC

Provider Actions and Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for all ustekinumab subcutaneous products (preferred and non-preferred). Approvals are provided for the duration specified in the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy. Providers must submit PA requests per that standard policy.

All ustekinumab products require the standard prior authorization with dosing criteria
Approvals follow durations in the standard prior authorization policy

Documentation Required

Documentation of prior trials and adverse reaction rationale

When documentation is required to support trials of Preferred products or rationale for not using them due to formulation differences/adverse reactions, acceptable documentation includes chart notes, prescription claims records, and prescription receipts. All documentation must include patient-identifying information.

Applicable Codes

Preferred Products (Step 1)NDC|mixedCovered

Imuldosa SC	NDCs starting with 69448 (Preferred Imuldosa NDC prefix)
Selarsdi SC	Selarsdi subcutaneous product
ustekinumab-ttwe SC	ustekinumab-ttwe subcutaneous
Yesintek SC	Yesintek subcutaneous

Step 2 Non-Preferred (directed to ONE Preferred)mixed

Stelara SC

Stelara subcutaneous (requests directed to one Preferred Product)

Step 3 Non-Preferred (directed to ALL Preferred)mixed

Otulfi SC	Otulfi subcutaneous (non-preferred)
Pyzchiva SC	Pyzchiva subcutaneous (NDCs starting with 61314) - non-preferred
Starjemza SC	Starjemza subcutaneous (non-preferred)
Steqeyma SC	Steqeyma subcutaneous (non-preferred)
ustekinumab SC	ustekinumab subcutaneous (Janssen Biotech) - non-preferred except 45mg vial special handling
ustekinumab-aekn SC	ustekinumab-aekn subcutaneous (non-preferred)

Non-Covered ProductsNDC|mixedNot Covered

Imuldosa SC	NDCs starting with 51407 (non-covered)
Pyzchiva SC	NDCs starting with 83457 (non-covered)
ustekinumab-aauz SC	ustekinumab-aauz subcutaneous (non-covered)
Wezlana SC	Wezlana subcutaneous (non-covered)

Products listed in policy header / covered options (neutral listing)mixed

Stelara	ustekinumab subcutaneous injection - Janssen Biotech (listed in header)
Imuldosa (Accord)	ustekinumab-srlf subcutaneous injection - Accord
Otulfi (Formycon/Fresenius)	ustekinumab-aauz etc.
Pyzchiva (Sandoz/Samsung, Cordavis)	listed
Selarsdi (Alvotech/Teva)	listed
Starjemza (BioThera)	listed
Steqeyma (Celltrion)	listed
ustekinumab-aauz	listed
ustekinumab-aekn	listed
ustekinumab-ttwe	listed

1–10 of 12

1/2

Appendix A - Other (Non-Ustekinumab) Preferred Products by IndicationmixedCovered

Adalimumab Products	includes adalimumab-adbm/Cyltezo, Simlandi/adalimumab-ryvk (-ryvk NDCs starting with 82009)
Enbrel	etanercept
Otezla/Otezla XR	apremilast
Skyrizi SC	risankizumab subcutaneous
Sotyktu	deucravacitinib tablets
Taltz	ixekizumab
Tremfya SC	guselkumab subcutaneous (added to Appendix A as Preferred for Crohn's)
Zymfentra	listed for Crohn's
Omvoh SC	listed for Crohn's/UC
Velsipity	listed for UC

Background

Ustekinumab subcutaneous products include the originator (Stelara) and multiple biosimilars; biosimilars are approved as having no clinically meaningful differences in safety or effectiveness compared with Stelara but may have minor differences in clinically inactive components (e.g., stabilizers, buffers, surfactants). This policy is intended to encourage use of designated Preferred Products while managing access to Non-Preferred and biosimilar options through prior authorization, documentation of prior trials, and exception criteria.

Preferred Product: Products that the program directs patients to try first (Step 1 Preferred list), for example Imuldosa (NDCs starting with 69448), Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous.

Non-Preferred Product Exception Criteria: Conditions under which non-preferred ustekinumab products may be approved, which include meeting the standard prior authorization criteria plus documented trials of required Preferred products or prescriber documentation that formulation differences in inactive ingredients would cause a significant allergy or serious adverse reaction; additional exception pathways exist for patients currently taking Stelara or when the 45mg vial is requested under the medical benefit.

Revision History

04/15/2025added

New policy created (New, Date 04/15/2025).

05/15/2025added

Tremfya subcutaneous added to Appendix A as a Preferred Non-Ustekinumab Product for Crohn's disease.

09/01/2025revised

Ustekinumab and ustekinumab-aekn were added as Non-Preferred subcutaneous products; requests initially directed to Stelara and Selarsdi respectively (later harmonized into same exception criteria).