CurrentCignaPolicy PSM021

Ustekinumab Subcutaneous Products Preferred Specialty Management Policy for Standard/Performance, Value/Advantage, and Total Savings Prescription Drug Lists

Cigna coverage policy governing prior authorization, step therapy, and preferred/non-preferred status for ustekinumab subcutaneous products across specified pharmacy and medical benefit prescription drug lists; applies to Cigna-administered health benefit plans and providers requesting coverage.

Policy Summary

PayerCigna

PolicyUstekinumab Subcutaneous Products Preferred Specialty Management Policy for Standard/Performance, Value/Advantage, and Total Savings Prescription Drug Lists

Policy CodePolicy PSM021

Change TypeNew policymaterial revisions (step assignments, product designations)

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit documentation of trials of required Preferred products or of formulation-related allergy/serious adverse reaction to support exceptions.

SourceLink

POLICY UPDATE CHANGES

New policy created for management of ustekinumab subcutaneous products with preferred and non-preferred designations and exception criteria.

Stelara was moved from Preferred to a newly created Step 2 Non-Preferred category with specific exception options including continuation of therapy.

Several ustekinumab biosimilars and brands were added as Non-Preferred products and some products designated Non-Covered on certain employer plans.

Different handling for ustekinumab 45 mg vial: covered as Step 2 on the medical benefit but Step 3 Non-Preferred on the pharmacy benefit.

3step therapy steps defined (Preferred; Step 2 Non-Preferred; Step 3 Non-Preferred)

>10

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Non-Preferred Ustekinumab Products

Non-Preferred Product Exception Criteria

Non-Preferred ustekinumab products are considered medically necessary only when the listed exception criteria are met; otherwise they are not covered.

Imuldosa, Otulfi, Pyzchiva, Starjemza, Steqeyma, ustekinumab SC (pharmacy)

A: Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria
Documentation required per prior authorization policy
B: i. Patient has tried ALL of Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous [documentation required]; AND ii. Patient cannot continue to use ALL Preferred medications due to formulation differences in inactive ingredient(s) that, per the prescriber, would result in a significant allergy or serious adverse reaction [documentation required]. Note: A trial of Pyzchiva counts toward ustekinumab-ttwe; a trial of ustekinumab-aekn counts toward Selarsdi.

The following ustekinumab subcutaneous products are designated as Non-Covered for Employer Plans and are not approved for coverage under this policy: Imuldosa SC (NDCs starting with 51407), Pyzchiva SC (NDCs starting with 83457), ustekinumab-aauz SC, and Wezlana SC. Requests for these products should be redirected to Preferred Products per the patient’s benefit plan document.

Any exception request for Non-Preferred ustekinumab subcutaneous products that does not meet the specified non-preferred product exception criteria (including the requirements of the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy and the additional trial or continuation conditions) is considered not medically necessary and will not be approved.

Initial Therapy (Preferred Products)

Initial therapy requirements

Preferred products must be tried before Non-Preferred products unless exception criteria are met.

Step 1 Preferred: Patient should be started on one of Selarsdi, ustekinumab-ttwe, or Yesintek subcutaneous [documentation of trial required when used to support exception]

Preferred (Step 1) requirement per step therapy

Continuation Therapy

Continuation therapy

Continuation of therapy is allowed in specified situations; documentation per the standard prior authorization policy is required.

Continuation on Stelara: Approve continuation if the patient is currently taking Stelara subcutaneous (ustekinumab 45 mg vial); applies when requested on the medical benefit (45 mg vial covered as Step 2 on medical benefit). Documentation required per the standard prior authorization policy.

Continuation option for patients already on Stelara; medical benefit/pharmacy benefit distinction applies

Step Therapy Table and Assignments

Step	Products (examples)	Direction / Trial requirement	Coverage status
Step 1	Selarsdi SC; ustekinumab-ttwe SC; Yesintek SC	Preferred products; patient should be started on one of these prior to Non-Preferred products (documentation required when used to support exception)	Covered as Preferred
Step 2	Stelara SC; (ustekinumab subcutaneous 45 mg vial covered as Step 2 on the medical benefit only)	Non-Preferred Step 2 products are directed to ONE Preferred product; approval requires meeting standard prior authorization criteria AND either trial of ONE Preferred product plus inability to continue due to formulation-related allergy/serious adverse reaction (documentation required) OR patient currently taking Stelara (continuation)	Non-Preferred (exceptions allowed per criteria); coverage depends on meeting exception criteria; Stelara continuation allowed (medical benefit 45 mg vial)
Step 3	Imuldosa SC (NDCs starting with 69448); Otulfi SC; Pyzchiva SC (NDCs starting with 61314); Starjemza SC; Steqeyma SC; ustekinumab SC; ustekinumab-aekn SC	Non-Preferred Step 3 products are directed to ALL Preferred products; approval requires meeting standard prior authorization criteria AND trials of ALL Preferred products plus inability to continue due to formulation-related allergy/serious adverse reaction (documentation required)	Non-Preferred (coverage only if exception criteria met)
Non-Covered	Imuldosa SC (NDCs starting with 51407); Pyzchiva SC (NDCs starting with 83457); ustekinumab-aauz SC; Wezlana SC	These products are non-covered for Employer Plans and requests should be directed to Preferred Products; refer to customer benefit plan document	Not covered

NDC Ranges, Step Assignment, and Coding

Preferred Products (Step 1)NDCCovered

82009	Selarsdi SC and related NDCs starting with 82009 — Preferred
ustekinumab-ttwe	ustekinumab-ttwe SC — Preferred
Yesintek	Yesintek SC — Preferred

Non-Preferred Products (Step 2)NDC

Stelara

Stelara SC — directs to ONE Preferred Product (documentation required)

Non-Preferred Products (Step 3)NDCNot Covered

Imuldosa	Imuldosa SC (NDCs starting with 69448) — Step 3 Non-Preferred
Otulfi	Otulfi SC — Step 3 Non-Preferred
Pyzchiva	Pyzchiva SC (NDCs starting with 61314) — Step 3 Non-Preferred
Starjemza	Starjemza SC — Step 3 Non-Preferred
Steqeyma	Steqeyma SC — Step 3 Non-Preferred
ustekinumab	ustekinumab SC (including Janssen product) — Step 3 Non-Preferred for pharmacy benefit; medical benefit may differ
ustekinumab-aekn	ustekinumab-aekn SC — Step 3 Non-Preferred

Non-Covered ProductsNDCNot Covered

Imuldosa	Imuldosa SC (NDCs starting with 51407) — Non-covered
Pyzchiva	Pyzchiva SC (NDCs starting with 83457) — Non-covered
ustekinumab-aauz	ustekinumab-aauz SC — Non-covered
Wezlana	Wezlana SC — Non-covered

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization Required — follow the standard prior authorization policy and obtain approval per the Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy. Approvals are provided for the duration specified in that standard policy. If the patient meets the standard prior authorization criteria but has not tried the Preferred Products, consider review under the standard prior authorization policy for the Preferred Products.

Refer to the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy for full dosing and duration requirements.
All requests for Non-Preferred Products will be reviewed using the Non-Preferred Product exception criteria (see criteria section).

Step Therapy

Step Therapy Requirements

Step therapy is required: patients must try Preferred Products before Non-Preferred Products. Step sequencing is defined in the policy: Step 1 = Preferred Products (Selarsdi SC, ustekinumab-ttwe SC, Yesintek SC); Step 2 = directed Non-Preferred (Stelara SC directed to ONE Preferred Product); Step 3 = other Non-Preferred products directed to ALL Preferred Products. Non-covered products listed in the policy are not eligible for benefit.

Benefit-specific Site of Care / Benefit Handling

Note

Benefit-specific handling for ustekinumab 45 mg vial

Coverage differs by benefit for the ustekinumab 45 mg vial: it is covered as a Step 2 product on the medical benefit but is a Step 3 Non-Preferred product on the pharmacy benefit.

If requesting coverage under the medical benefit for the 45 mg vial, the product is Step 2 and may allow continuation per the policy.
For pharmacy benefit requests the 45 mg vial is Step 3 Non-Preferred and must meet Step 3 criteria.

Biosimilar and Stelara Designation

Billing Rule

Stelara and biosimilars — preferred/non-preferred designations

Biosimilars are included; products are designated Preferred, Non-Preferred, or Non-Covered per the Step table (Step 1 Preferred; Step 2 Stelara; Step 3 Non-Preferred; specific Non-Covered products listed).

Preferred examples: Selarsdi, ustekinumab-ttwe, Yesintek.
Step 2 example: Stelara SC (directed to one Preferred product for approval).
Non-Covered examples for Employer Plans: Imuldosa (NDCs starting with 51407), Pyzchiva (NDCs starting with 83457), ustekinumab-aauz SC, Wezlana SC.

Definitions

Definition of 'Biosimilar'

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

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

Clinical implicationBiosimilars are considered therapeutically comparable to Stelara for indications where approved.

Background

Ustekinumab subcutaneous products include the reference product (Stelara) and multiple biosimilars and branded subcutaneous ustekinumab injections. The policy groups products into steps for preferred management: Step 1 (Preferred) includes Selarsdi SC, ustekinumab-ttwe SC, and Yesintek SC; Step 2 includes Stelara SC (non-preferred on pharmacy benefit but covered as Step 2 on the medical benefit for the 45 mg vial); and Step 3 (Non-Preferred) includes several biosimilars and other ustekinumab products (e.g., Imuldosa SC, Otulfi SC, Pyzchiva SC, Starjemza SC, Steqeyma SC, ustekinumab SC, ustekinumab-aekn SC). Non-preferred products may be approved only when the policy’s exception criteria are met (standard prior authorization criteria plus required trials of Preferred products or documented inability to continue Preferred medications), and the policy directs prescribers to follow the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy for documentation and approval durations.