CurrentCignaPolicy PSM024

Inflammatory Conditions – Ustekinumab Intravenous Products Preferred Specialty Management Policy - (PSM024)

Defines preferred, non-preferred, and non-covered ustekinumab IV products for inflammatory conditions, requirement to meet standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy, and exception criteria for approving non-preferred products after trials of preferred products with documentation.

Policy Summary

PayerCigna

PolicyInflammatory Conditions – Ustekinumab Intravenous Products Preferred Specialty Management Policy - (PSM024)

Policy CodePolicy PSM024

Change TypeNew and revised product classifications

Effective Date05/15/2026

Next Review Date

Key ActionAll ustekinumab IV products require meeting the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy criteria before approval.

SourceLink

POLICY UPDATE CHANGES

New policy created; Ustekinumab IV products grouped into Preferred, Non-Preferred, and Non-Covered.

Stelara/ustekinumab IV moved from Preferred to Non-Preferred and now shares exception criteria with other Non-Preferred agents.

Imuldosa (ustekinumab-srlf) moved between Non-Preferred and Preferred depending on NDC ranges; specific NDC ranges identified as Preferred (69448) vs Non-Covered (51407).

All non-preferred products require trials of ALL Preferred products with documentation; a trial of Imuldosa NDCs starting with 51407 also counts toward trial requirement.

3Preferred Products

5Non-Preferred Products

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Coverage Summary

Defines Preferred, Non-Preferred, and Non-Covered ustekinumab IV products for inflammatory conditions and requires that all ustekinumab IV requests meet the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy criteria. The program encourages use of Preferred Products and directs patients to try Preferred Products prior to approval of Non-Preferred Products; Non-Preferred products are approved only when the exception criteria (including documented trials of all Preferred products and documented inability to use Preferred products due to formulation-related intolerance) are met. Imuldosa IV NDC ranges determine Preferred vs Non-Covered status per the policy. Policy number PSM024. Effective and last review date: 05/15/2026.

Policy dates and status

Effective date2026-05-15

Last review date2026-05-15

Next review dateTBD

StatusCURRENT

Policy numberPSM024

General / Initial Authorization Criteria

General Requirement

All ustekinumab IV products (preferred and non-preferred) require meeting the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy criteria.

Patient meets the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy

Preferred Products Policy Direction

Program encourages use of Preferred Products; patients should try Preferred Products prior to approval of Non-Preferred Products. If standard PA criteria are met but Preferred Products have not been tried, request may be reviewed for Preferred Products using the standard PA criteria.

Preferred Products are approved when standard PA criteria are met and prescriber selects a Preferred product

If PA criteria met but Preferred Products not tried, the request may be reviewed for Preferred Products (Imuldosa NDCs starting with 69448, Selarsdi, Yesintek) using standard PA criteria

Non-Preferred Product Exception Criteria (Continuation / Exception)

Non-Preferred Product Exception Criteria (medically necessary only if exception met)

Approve non-preferred ustekinumab IV products only when ALL of the following are met:

ALL of the following

Patient meets the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy
B
- Patient has tried ALL preferred products: Imuldosa (NDCs starting with 69448), Selarsdi, and Yesintek intravenous
  Documentation required; a trial of Imuldosa NDCs starting with 51407 also counts
- Patient cannot continue to use ALL Preferred medications due to formulation differences in inactive ingredient(s) which, according to the prescriber, would result in a significant allergy or serious adverse reaction

Non‑Covered Products / Exclusions

Non-Covered Products

Listed products are not covered on pharmacy and medical benefits for Employer Plans and Individual and Family Plans; refer to customer's benefit document for exceptions.

Imuldosa IV (NDCs starting with 51407) - listed as Non-Covered

Wezlana IV - listed as Non-Covered

Preferred Product: A ustekinumab IV product that the program encourages use of and directs patients to try prior to non-preferred products (examples: Imuldosa IV NDCs starting with 69448, Selarsdi IV, Yesintek IV).

Non-Preferred Product: A ustekinumab IV product that requires exception criteria to be approved — specifically, trials of ALL Preferred products with documentation and documented inability to continue Preferred products due to formulation differences in inactive ingredients.

Non-Covered Product: A product not covered on pharmacy and medical benefits for Employer Plans and Individual and Family Plans (examples: Imuldosa IV NDCs starting with 51407, Wezlana IV).

Applicable Codes

Preferred Products (by product name / NDC start)NDC|mixedCovered

Imuldosa IV	NDCs starting with 69448 (Preferred)
Selarsdi IV	Preferred
Yesintek IV	Preferred

Non-Preferred Products (require exception criteria and documentation)mixed

Otulfi IV	Non-Preferred; directed to try ALL Preferred products first
Pyzchiva IV	Non-Preferred; directed to try ALL Preferred products first
Starjemza IV	Non-Preferred; directed to try ALL Preferred products first
Stelara IV / ustekinumab IV	Non-Preferred; directed to try ALL Preferred products first
Steqeyma IV	Non-Preferred; directed to try ALL Preferred products first

Non-Covered ProductsNDC|mixedNot Covered

Imuldosa IV	NDCs starting with 51407 - Non-Covered
Wezlana IV	Non-Covered

Provider Actions / Requirements

Prior Authorization

Standard Prior Authorization Required

All ustekinumab IV products require meeting the standard Inflammatory Conditions - Ustekinumab Intravenous Products Prior Authorization Policy criteria before approval.

Documentation Required

Documentation of Trials

Prescriber must provide written documentation showing trials of Preferred products when requesting a non-preferred product. Documentation may include chart notes, prescription claims records, and/or prescription receipts and must include patient-identifying information. Trials must demonstrate attempts of the Preferred products: Imuldosa intravenous with NDCs starting with 69448, Selarsdi IV, and Yesintek IV.

Acceptable documentation types: chart notes, prescription claims records, prescription receipts
All documentation must include patient-identifying information
Trials must show attempts of Preferred products: Imuldosa (NDCs starting with 69448), Selarsdi, Yesintek

Clinical Evidence & References

Prescribing information references: 10 prescribing information documents cited (Stelara, unbranded ustekinumab, Wezlana, Otulfi, Pyzchiva, Selarsdi, Steqeyma, Yesintek, Imuldosa, Starjemza) dated 2024–2026. The policy relies on prescribing information and on the regulatory determination that biosimilars have no clinically meaningful differences in safety and effectiveness and share mechanism of action, route, dosage form, and strength with Stelara. No trial metric cards are provided in the brief.

Background

Ustekinumab IV products treat a variety of inflammatory conditions; multiple biosimilar ustekinumab products exist and were approved as biosimilars to Stelara, sharing the same mechanism of action, route of administration, dosage form, and strength though minor differences in inactive ingredients are allowed. The purpose of this policy is to encourage use of Preferred Products and to manage utilization among biosimilars and branded ustekinumab IV products by directing patients to Preferred Products and applying exception criteria for Non-Preferred agents. The scope of the policy and non-coverage statements apply to Employer Plans and Individual & Family Plans, and customers' benefit documents may supersede the policy where applicable.

Revision History

04/15/2025initial_policy

Initial policy created and made effective; ustekinumab IV products were grouped into Preferred, Non-Preferred, and Non-Covered categories (new policy effective 04/15/2025).

09/01/2025classification_change

Imuldosa (ustekinumab-srlf) was added to the policy as a Non-Preferred product and documentation requirements for trials and formulation-difference intolerance were specified.

11/13/2025classification_change