Cigna ustekinumab SC Coverage Update Prior Auth

Coverage and Exception Criteria

Non-Preferred Product Exception Criteria

Ustekinumab subcutaneous non-preferred products are considered medically necessary only when the stated exception criteria are met.

Overall: Approve only if patient meets BOTH: (A) standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria; AND (B) the applicable exception criteria for the requested non-preferred product.

See product-specific branches for B.

Exception Group 1 (Imuldosa 69448, Otulfi, Pyzchiva 61314, Starjemza, etc.): B: Patient meets BOTH of the following: (i) documentation that patient meets standard prior authorization criteria; AND (ii) patient meets BOTH: (a) patient has tried ALL Preferred products as required by the step rules or as specified in the policy (trial/documentation required per product-level directions) OR for some products per policy a trial of ONE Preferred product may be sufficient (see product branch); AND (b) patient cannot continue to use ALL Preferred medications due to formulation differences in inactive ingredient(s) (e.g., stabilizing agent, buffering agent, surfactant) that, according to the prescriber, would result in a significant allergy or serious adverse reaction (documentation required).

Applies to Step 3 non-preferred product group; documentation required.

Exception Group 2 (Steqeyma, ustekinumab SC vial pharmacy requests, ustekinumab-aekn): B: For requests involving ustekinumab SC vial on the pharmacy benefit or products listed in this group, patient must meet BOTH: (i) documentation that patient has tried ustekinumab-ttwe and Yesintek subcutaneous (documentation required) ; AND (ii) patient cannot continue to use ALL Preferred medications (Stelara syringes, Selarsdi, ustekinumab-ttwe, Yesintek) because of formulation differences in inactive ingredients that would cause a significant allergy or serious adverse reaction per prescriber (documentation required).

Special handling when ustekinumab 45mg vial is requested for pharmacy benefit; vial is Step 2 on medical benefit only.

Alternate exception path (some non-preferred products): B: Approve if patient meets BOTH: (A) standard prior authorization criteria; AND (B) ONE of the following: (i) patient has tried ONE of Stelara syringe, Selarsdi, ustekinumab-ttwe, or Yesintek subcutaneous (documentation required) AND cannot continue the Preferred medication(s) due to inactive-ingredient formulation differences causing significant allergy or serious adverse reaction (documentation required); OR (ii) patient is currently taking Stelara subcutaneous 45mg vial (or ustekinumab 45mg vial where noted) and continuation on that vial formulation is the basis for the exception.

This alternate path appears in policy for selected non-preferred products and when continuing a vial formulation.

The following products are not covered on the pharmacy and medical benefits for Employer Plans: Imuldosa subcutaneous (NDCs starting with 51407), Pyzchiva subcutaneous (NDCs starting with 83457), ustekinumab-aauz subcutaneous, and Wezlana subcutaneous. Refer to the customer's benefit plan document for details of covered product(s).

In contrast, other ustekinumab subcutaneous products are managed within a three-tier step-therapy framework: Step 1 (Preferred), Step 2 (Non-Preferred directed to ONE Preferred product), and Step 3 (Non-Preferred directed to ALL Preferred products). Non-preferred product approvals are allowed only when the policy's exception criteria are satisfied and the member meets the standard Inflammatory Conditions prior authorization requirements.

Any request for a Non-Preferred ustekinumab subcutaneous product that does not meet the stated exception criteria is considered not medically necessary. Approvals for Non-Preferred products require that the patient meet BOTH: (A) the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria; AND (B) the product-specific exception criteria (for example, documented trial(s) of Preferred product(s) and documented inability to continue Preferred agents due to formulation differences, or continuation on a specified vial formulation).

NDCs and Product Codes

NDC groupings and product-specific codesNDC

NDCs starting with 69448	Imuldosa SC (Step 3 Non-Preferred)
NDCs starting with 61314	Pyzchiva SC (Step 3 Non-Preferred)
NDCs starting with 51407	Imuldosa SC (Non-Covered for Employer Plans)
NDCs starting with 83457	Pyzchiva SC (Non-Covered for Employer Plans)
Various product NDCs referenced in Appendix and revisions	Other product-specific NDC groupings (see Appendix/References)

Product-level codes (non-NDC identifiers noted in policy text)mixed

Imuldosa SC	Imuldosa (ustekinumab-srlf) - referenced with NDC groupings
Otulfi SC	Otulfi (ustekinumab-aauz) - listed as Step 3 Non-Preferred
Pyzchiva SC	Pyzchiva (ustekinumab-ttwe) - referenced with NDC groupings
Starjemza SC	Starjemza (ustekinumab-hmny) - listed as Step 3 Non-Preferred
Steqeyma SC	Steqeyma (ustekinumab-stba) - listed as Step 3 Non-Preferred
ustekinumab SC 45mg vial	Ustekinumab subcutaneous injection (Janssen Biotech) 45mg vial - Step 2 on medical benefit, Step 3 on pharmacy benefit
ustekinumab-aekn SC	ustekinumab-aekn SC - listed as Step 3 Non-Preferred
ustekinumab-aauz SC	ustekinumab-aauz SC - listed as Non-Covered for Employer Plans
Wezlana SC	Wezlana SC - listed as Non-Covered for Employer Plans

Provider Requirements and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for all ustekinumab subcutaneous products prescribed for inflammatory conditions. Requests will be evaluated using the Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria. approvals are provided for the duration specified in that standard prior authorization policy.

All ustekinumab SC products (preferred and non-preferred) require prior authorization under the inflammatory conditions prior authorization policy.
Approvals follow the duration and dosing rules in the referenced prior authorization policy.

Step Therapy

Step Therapy Directions

Step therapy requires prescribers to try Preferred Products before Non-Preferred Products except when an exception criterion is met and documented. The program is structured in sequential steps directing trials of specific preferred products first; requests for non-preferred agents must meet the stated exception criteria to be approved.

Step 1 (Preferred): Stelara SC 45mg syringe, Stelara SC 90mg syringe, Selarsdi SC, ustekinumab-ttwe SC, Yesintek SC — preferred-first requirement.

Clinical and Policy Background

Ustekinumab subcutaneous products (including the reference product Stelara and multiple biosimilars) are indicated for a variety of inflammatory conditions. Multiple ustekinumab biosimilars have been approved as clinically equivalent to Stelara and may differ only in inactive components. The policy directs use of Preferred Products first and permits exceptions when differences in inactive ingredients cause a documented significant allergy or serious adverse reaction or when medical-benefit vial formulations require continuation.

Key Definitions

Biosimilar — definition and relation to Stelara

DefinitionBiosimilar: a product with no clinically meaningful differences in safety and effectiveness and the same mechanism of action, route, dosage form, and strength as Stelara; minor differences in inactive components are allowed.

Regulatory implicationBiosimilars are approved as equivalent to Stelara in clinical performance (safety and effectiveness).

Clinical interchangeabilityBiosimilars share the same mechanism of action and route of administration as Stelara, supporting substitution when permitted by coverage rules.

Relation to StelaraBiosimilars are explicitly described as having no clinically meaningful differences compared to Stelara and therefore reference Stelara as the reference product.

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

Initial (Step 1) Therapy Requirements

Initial preferred therapy

Step 1 preferred initiation

Step 1 Preferred Products: Preferred Products: Stelara SC 45mg syringe and 90mg syringe; Selarsdi SC; ustekinumab-ttwe SC; Yesintek SC.

Patients are directed to these products first; trials of these products are required before Non-Preferred products per step therapy rules.

Continuation and Maintenance Therapy

Continuation therapy notes

Continuation/maintenance considerations

Continuation on vial formulation: Patient currently taking Stelara subcutaneous 45mg vial (or ustekinumab 45mg vial in clauses where noted) may be approved to continue that therapy as a basis for exception to Non-Preferred restrictions.

Ustekinumab 45mg vial is Step 2 on the medical benefit only; pharmacy benefit coverage may be Step 3—refer to product-specific rules and document continuation.

Step Designations and Product Listing

Step	Condition / Requirement	Trial requirement	Coverage status
Step 1 (Preferred)
Preferred Products are the first-line agents: Stelara SC 45mg syringe and 90mg syringe; Selarsdi SC; ustekinumab-ttwe SC; Yesintek SC.
No prior trial of preferred products required to start Preferred therapy; patients should be initiated on these agents per standard prior authorization policy.
Preferred

Step	Products / Note	Condition / Requirement	Coverage status
Step 2
Stelara SC 45mg vial; Ustekinumab subcutaneous injection (Janssen Biotech) 45mg vial
Directed to ONE Preferred Product (documentation required). Note: the Janssen 45mg vial is covered as a Step 2 product on the medical benefit only; when requested under the pharmacy benefit it is Step 3 (see Step 3 criteria). Trial of one Preferred product or current use of the vial formulation may satisfy exception paths per the standard prior authorization criteria and exception criteria.
Non-Preferred

Step	Non-Preferred products (pharmacy benefit)	Exception criteria / Trial requirement	Coverage status
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
Directed to ALL Preferred Products with documentation required. Approve only if patient meets both: (A) standard Inflammatory Conditions prior authorization criteria; AND (B) either (i) patient has tried ONE Preferred product (Stelara syringe, Selarsdi, ustekinumab-ttwe, or Yesintek SC) and cannot continue Preferred medications due to formulation differences in inactive ingredients causing a significant allergy or serious adverse reaction (documentation required), or (ii) patient is currently taking the specified 45mg vial formulation as noted in the policy. A trial of Pyzchiva counts toward ustekinumab-ttwe; a trial of ustekinumab counts toward Stelara; a trial of ustekinumab-aekn counts toward Selarsdi.
Non-Preferred

Benefit Type and Site-of-Care Differences

Note

Medical benefit vs pharmacy benefit coverage differs for vial formulations

Coverage differs by benefit type for certain formulations: the ustekinumab (Stelara) 45mg vial is covered as a Step 2 product on the medical benefit but is treated as a Step 3 non-preferred product on the pharmacy benefit.

Refer to the step table: 45mg vial = Step 2 on medical benefit; for pharmacy benefit it is Step 3.

Biosimilar Handling and Preferred Status