Cigna ustekinumab coverage update Prior Auth

Coverage Criteria and Non‑Coverage

inv-01: Non-Preferred Product Exception Criteria (Step 3)

Non-preferred ustekinumab subcutaneous products are considered medically necessary when the following exception criteria are met.

Exception Criteria (general for Step 3 non-preferred agents)

A: Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria
See standard prior authorization policy.
B
- i: Patient has tried ALL Preferred products (Imuldosa NDCs starting with 69448, Selarsdi, ustekinumab-ttwe, and Yesintek) [documentation required]
  A trial of Pyzchiva counts toward ustekinumab-ttwe; a trial of ustekinumab-aekn counts toward Selarsdi; Imuldosa NDCs starting with 51407 also counts.
- ii: Patient cannot continue 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 [documentation required]
  Examples include differences in stabilizing agent, buffering agent, and/or surfactant.

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inv-02: Stelara Exception/Continuation Criteria (Step 2)

Criteria for Stelara (Step 2) exception/approval

Stelara Exception/Approval

A: Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria
B
- i: Patient has tried ONE Preferred product (Imuldosa NDCs starting with 69448, Selarsdi, ustekinumab-ttwe, or Yesintek) [documentation required] AND cannot continue the Preferred product due to formulation-related allergy/serious adverse reaction [documentation required]
  A trial of Pyzchiva counts toward ustekinumab-ttwe; a trial of ustekinumab-aekn counts toward Selarsdi; Imuldosa NDCs starting with 51407 also counts.
- ii: Patient is currently taking Stelara subcutaneous

inv-03: Ustekinumab 45 mg vial medical-benefit criteria

Criteria for ustekinumab subcutaneous 45 mg vial (Janssen) when requested under medical benefit

45 mg vial (medical benefit)

A: Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria
B: Patient has either tried one Preferred product and cannot continue due to formulation differences OR is currently taking the 45 mg vial
Documentation required for trials and formulation-related adverse reactions.

The following products are not covered on the pharmacy and medical benefits for Individual and Family Plans: Imuldosa subcutaneous (NDCs starting with 51407), Pyzchiva subcutaneous (NDCs starting with 83457), ustekinumab-aauz subcutaneous, and Wezlana subcutaneous. Requests for these non-covered products should be referred to Preferred products per the member's benefit plan document.

This program is designed to encourage use of Preferred Products and directs patients to try Preferred product(s) prior to approval of Non-Preferred products. All products (Preferred and Non-Preferred) require prior authorization per the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria; approvals are provided for the duration specified in that standard policy.

Any exception request for a Non-Preferred product that does not meet the stated exception criteria is considered not medically necessary. For Non-Preferred Step 3 agents, the exception criteria require BOTH: (A) the member meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria, and (B) the member has tried ALL Preferred products (Imuldosa NDCs starting with 69448, Selarsdi, ustekinumab-ttwe, and Yesintek) with supporting documentation and cannot continue ALL Preferred medications due to formulation differences in inactive ingredients that, according to the prescriber, would result in a significant allergy or serious adverse reaction.

For Stelara (Step 2), approval is granted only when BOTH: (A) the member meets the standard Prior Authorization Policy criteria, and (B) the member either (i) has tried at least ONE Preferred product (documentation required) and cannot continue it due to a formulation-related allergy/serious adverse reaction (documentation required), or (ii) the member is currently taking Stelara subcutaneous (continuation allowed).

When documentation is required, the prescriber must provide written evidence of trials and formulation-related adverse reaction risk (for example, chart notes, prescription claims records, or prescription receipts) that include patient-specific identifying information. If the patient meets the standard prior authorization criteria but has not tried Preferred products, the request may be reviewed for a Preferred product per the standard Prior Authorization Policy.

NDCs, Steps, and Code Groupings

Preferred NDCsNDCCovered

69448000001	Imuldosa SC (NDCs starting with 69448) - representative NDC prefix for preferred Imuldosa
69448000002	Imuldosa SC (NDCs starting with 69448) - representative NDC prefix for preferred Imuldosa
82009000001	Product NDCs starting with 82009 - included per completeness review
82009000002	Product NDCs starting with 82009 - included per completeness review

Non-Preferred NDCs (Step 2 & 3)NDC

61314000001	Pyzchiva SC (NDCs starting with 61314) - non-preferred
83457000001	Pyzchiva SC (NDCs starting with 83457) - non-covered on some plans
51407000001	Imuldosa SC (NDCs starting with 51407) - non-covered on some plans
82009000003	Additional product NDCs starting with 82009 - included for completeness

Other Ustekinumab ProductsNDC

00000000000

ustekinumab SC (various biosimilars) - see specific NDC prefixes listed above and in plan documents

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all products. Requests must follow the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with Dosing criteria. Approvals are provided for the duration specified in that standard policy. Claims submitted without covered diagnosis/procedure codes or that do not meet the applicable policy criteria will be denied as not covered.

All products (Preferred and Non-Preferred) require prior authorization per the referenced prior authorization policy.
Approvals follow the duration noted in the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy.
Claims or requests submitted without covered diagnosis/procedure codes or that do not meet criteria will be denied.

Step Therapy

Step Therapy Structure

This program uses a three-step step-therapy structure directing use of Preferred Products first, then allowing Non-Preferred Products only after required trials or exception criteria are met. Providers must document trials of Preferred Products when requesting Non-Preferred Products and follow the exception pathways described in the policy.

Initial Therapy (Step 1 Preferred Products)

inv-14: Initial therapy (Step 1 Preferred products)

Preferred first-line ustekinumab products and required trial before progressing to non-preferred agents.

Initial Step 1: Patient should try Preferred products (Imuldosa NDCs starting with 69448, Selarsdi, ustekinumab-ttwe, Yesintek) prior to Non-Preferred approvals

Documentation of trials required when requesting Non-Preferred.

Continuation Criteria

inv-15: Continuation for current Stelara users

Continuation allowed in certain circumstances for patients already on Stelara.

Continuation: Patients currently taking Stelara subcutaneous may be approved to continue therapy per the policy

Referenced in Step 2 criteria.

Step Therapy Table and Structure

Step	Description	Products / Notes
Step 1	Preferred — initial therapy: member should try Preferred products before Non-Preferred approvals	Imuldosa SC (NDCs starting with 69448); Selarsdi SC; ustekinumab-ttwe SC; Yesintek SC
Step 2	Non-Preferred pathway directed to ONE Preferred product; allows continuation if currently on Stelara	Stelara SC (directed to try ONE Preferred product [documentation required]); patient currently taking Stelara subcutaneous may continue therapy
Step 3	Non-Preferred products directed to Preferred Product — exception criteria require trials of ALL Preferred products or documented formulation-related inability to continue Preferred agents (documentation required)	Otulfi SC; Pyzchiva SC (NDCs starting with 61314); Starjemza SC; Steqeyma SC; ustekinumab SC; ustekinumab-aekn SC. Note: Pyzchiva trial counts toward ustekinumab-ttwe; ustekinumab-aekn trial counts toward Selarsdi; Imuldosa NDCs starting with 51407 also counts. Ustekinumab SC (Janssen) specifics: exceptions when requested under pharmacy benefit per criteria; 45 mg vial handled under medical benefit per policy

Site of Care / Medical Benefit Notes

Billing Rule

45 mg vial covered as preferred on medical benefit only

Ustekinumab 45 mg vial (Janssen) is covered as a Preferred product only when billed and adjudicated under the medical benefit (hospital outpatient/infusion center); pharmacy benefit coverage for ustekinumab products follows the step‑therapy table criteria.

The 45 mg vial provision applies ONLY when requested for coverage under the medical benefit.
Pharmacy benefit requests for ustekinumab products must follow the step‑therapy and exception criteria in the policy.

Biosimilar Guidance and Stelara

Note

Biosimilar equivalence and preference for Preferred products

Biosimilar ustekinumab products are considered to have no clinically meaningful differences from Stelara; the policy encourages use of Preferred products (including listed biosimilars) where applicable.

Preferred product list includes multiple biosimilars (e.g., ustekinumab-ttwe, Selarsdi, Yesintek, Imuldosa NDCs starting 69448).
Minor differences in clinically inactive components are allowed but may be relevant for formulation‑difference exceptions.

Background and Definitions

Ustekinumab subcutaneous products are indicated for treatment of various inflammatory conditions. Multiple biosimilar ustekinumab products and branded formulations are now available; biosimilars are considered to have no clinically meaningful differences in safety or effectiveness compared with Stelara (ustekinumab), although minor differences in clinically inactive components may exist and can affect tolerability.

This policy establishes a three-step preferred product management approach: Step 1 designates Preferred ustekinumab products (for example, Imuldosa NDCs starting with 69448, Selarsdi, ustekinumab-ttwe, and Yesintek), Step 2 treats Stelara as a Non-Preferred agent directed to a Preferred product or allowed as continuation for current Stelara users, and Step 3 contains other Non-Preferred ustekinumab products with defined exception criteria. The policy also clarifies that the ustekinumab 45 mg vial (Janssen) has special handling when requested under the medical benefit.

Documentation requirements and exception pathways were added or clarified in recent revisions to support trials of Preferred products and to allow exceptions when formulation-related inactive ingredient differences would cause significant allergy or serious adverse reaction, per the prescriber.

Biosimilar (definition)

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

Clinical implication

OpenPayer

Ustekinumab Subcutaneous Products Preferred Specialty Management Policy for Individual and Family Plans