Cigna ustekinumab subcutaneous Coverage Update

Coverage Criteria for Ustekinumab Subcutaneous Products

Non-Preferred Product Exception Criteria

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

Exception criteria for certain Non-Preferred agents (Otulfi SC, Pyzchiva SC (NDCs starting with 61314), Starjemza SC, Steqeyma SC, ustekinumab SC*, ustekinumab-aekn SC): Approve if the patient meets BOTH of the following (A and B): A) Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria; AND B) Patient meets BOTH of the following (i and ii): i. Patient has tried ALL of Stelara syringe, Imuldosa (NDCs starting with 69448), Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous [documentation required]; AND ii. Patient cannot continue to use ALL Preferred medications (Stelara syringe, Imuldosa [NDCs starting with 69448], Selarsdi, ustekinumab-ttwe, and Yesintek subcutaneous) due to formulation differences in the inactive ingredient(s) (e.g., stabilizing agent, buffering agent, and/or surfactant) which, according to the prescriber, would result in a significant allergy or serious adverse reaction [documentation required]. Note: A trial of Pyzchiva counts towards a trial of ustekinumab-ttwe; a trial of ustekinumab counts towards a trial of Stelara; a trial of ustekinumab-aekn counts towards a trial of Selarsdi; a trial of Imuldosa (NDCs starting with 51407) also counts.

*ONLY applies when ustekinumab SC injection (Janssen Biotech) is requested for pharmacy benefit coverage; 45mg vial has separate medical-benefit placement.

Alternate/less-restrictive exception for some Non-Preferred agents (e.g., Stelara SC 45mg vial requests): Approve if the patient meets BOTH A and B: A) Patient meets the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria; AND B) Patient meets ONE of the following (i or ii): i. Patient meets BOTH of the following (a and b): a) Patient has tried ONE of Stelara syringe, Imuldosa (NDCs starting with 69448), Selarsdi, ustekinumab-ttwe, or Yesintek subcutaneous [documentation required]; AND b) Patient cannot continue to use the Preferred medications (Stelara syringe, Imuldosa [NDCs starting with 69448], Selarsdi, ustekinumab-ttwe, or Yesintek subcutaneous) due to formulation differences in the inactive ingredient(s) which, according to the prescriber, would result in a significant allergy or serious adverse reaction [documentation required]; OR ii. Patient is currently taking Stelara subcutaneous 45mg vial (continuation option).

Applies when Stelara 45mg vial or ustekinumab 45mg vial is requested under the medical benefit (placement differs by benefit).

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).

Requests for any of these non-covered products should be reviewed against the member’s specific benefit plan; if the plan identifies the product as non-covered for that member, the product is not approved and the provider should pursue covered alternatives per the member’s benefit document.

Non-Preferred ustekinumab subcutaneous product requests that do not meet the published exception criteria are considered not medically necessary and will not be approved. The policy requires that Non-Preferred products meet the stated exception criteria in addition to the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy criteria.

If the patient meets the standard prior authorization criteria but fails to satisfy the exception criteria (for example, lacking required documented trials of Preferred Products or documented inability to use Preferreds due to inactive-ingredient intolerance/allergy), the request for the Non-Preferred product is not medically necessary and may be denied.

Coding and NDC Information

NDC code notes and product-specific NDC rangesNDC

NDCs starting with 69448	Imuldosa SC (Preferred product NDC range)
NDCs starting with 51407	Imuldosa SC (non-covered NDC range for Employer Plans)
NDCs starting with 61314	Pyzchiva SC (listed as Non-Preferred in some rows)
NDCs starting with 83457	Pyzchiva SC (non-covered NDC range for Employer Plans)
NDCs starting with 82009	Simlandi/adalimumab-ryvk (Preferred adalimumab NDC mentioned in appendix)
NDCs starting with 00074	Humira (Preferred adalimumab NDC mentioned in appendix)

Non-Covered NDCs and productsNDCNot Covered

NDCs starting with 51407	Imuldosa SC (non-covered on pharmacy and medical benefits for Employer Plans)
NDCs starting with 83457	Pyzchiva SC (non-covered on pharmacy and medical benefits for Employer Plans)
ustekinumab-aauz SC	ustekinumab-aauz subcutaneous (non-covered on pharmacy and medical benefits for Employer Plans)
Wezlana SC	Wezlana subcutaneous (non-covered on pharmacy and medical benefits for Employer Plans)

Coding accuracy reminder — use most appropriate codes as of date of service

Coding requirementWhen billing, providers must use the most appropriate codes as of the effective date of the submission.

Denial riskClaims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered.

Considerations at date of serviceReview the terms of the applicable benefit plan document in effect on the date of service and any applicable laws/regulations when selecting codes.

Supporting materialsRefer to relevant Coverage Policies and collateral source materials to determine covered codes for the service.

Clinical judgmentMedical directors may exercise clinical judgment for individual coverage determinations, but coding must still reflect the most appropriate codes as of the submission date.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for all ustekinumab subcutaneous products (Preferred and Non-Preferred). Members must meet the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy with dosing criteria. All approvals follow the duration specified in that standard prior authorization policy.

All requests (Preferred and Non-Preferred) governed by the standard Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy
Approvals provided for the duration noted in the standard prior authorization policy
If PA criteria are met but Preferred Products have not been tried, the request may be reviewed under the standard Prior Authorization Policy

Step Therapy

Step Therapy Direction

This program requires step therapy: members must try Preferred Products before Non-Preferred Products. The step direction defines which products should be tried first and what documentation is required to progress to subsequent steps.

Initial Therapy (Step 1 Preferred) Requirements

Initial therapy (Step 1 Preferred)

Preferred products must be tried before Non-Preferred products per the step therapy program.

Step 1 Preferred products: Patient must try Preferred products: Stelara SC 45mg syringe, Stelara SC 90mg syringe; Imuldosa SC (NDCs starting with 69448); Selarsdi SC; ustekinumab-ttwe SC; Yesintek SC.

Trials must be documented. The program may direct a trial of ONE or ALL Preferred products depending on the Non-Preferred step requested.

Step Therapy Table and Rules

Step	Products (examples)	Requirement before Non-Preferred approval	Documentation expected
Step 1 (Preferred)	Stelara SC 45mg syringe, Stelara SC 90mg syringe; Imuldosa SC (NDCs starting with 69448); Selarsdi SC; ustekinumab-ttwe SC; Yesintek SC	Preferred products must be tried prior to approval of Non‑Preferred products.	Standard prior authorization documentation per Inflammatory Conditions - Ustekinumab Subcutaneous Products Prior Authorization Policy.
Step 2 (Non‑Preferred)	Stelara SC 45mg vial; ustekinumab SC 45mg vial (medical benefit only for vial)	Directed trial of ONE Preferred Product required prior to approval of Step 2 Non‑Preferred agents.	Documentation of trial of ONE Preferred product and prescriber statement if inability to continue Preferreds due to inactive‑ingredient formulation differences (chart notes, prescription records, receipts acceptable).
Step 3 (Non‑Preferred)	Otulfi SC; Pyzchiva SC (NDCs starting with 61314); Starjemza SC; Steqeyma SC; ustekinumab SC; ustekinumab‑aekn SC	Directed trial of ALL Preferred Products required prior to approval of Step 3 Non‑Preferred agents.	Documentation of trials of ALL Preferred products OR prescriber documentation that patient cannot continue Preferreds due to formulation differences in inactive ingredients (significant allergy or serious adverse reaction).

Comparison	Step 2 expectation	Step 3 expectation	Documentation notes
Directed trial scope	Trial of ONE Preferred Product is required before Step 2 Non‑Preferred approval.	Trial of ALL Preferred Products is required before Step 3 Non‑Preferred approval.	Documentation must show which Preferred product(s) were tried and outcomes; acceptable evidence includes chart notes, prescription claims, and receipts.
Exception conditions	May approve if patient meets prior authorization criteria AND (has tried ONE Preferred product AND cannot continue Preferreds due to inactive ingredient formulation differences) OR is currently taking Stelara 45mg vial when applicable.	May approve only if patient meets prior authorization criteria AND (has tried ALL Preferred products AND cannot continue Preferreds due to inactive ingredient formulation differences) OR other specified continuation allowances per criteria.	Prescriber must document inability to use Preferreds due to formulation differences (e.g., stabilizer, buffer, surfactant) per prescriber statement; trials may substitute per policy notes (e.g., trial of Pyzchiva counts toward ustekinumab‑ttwe).
Benefit/setting differences	Ustekinumab 45mg vial may be covered as Step 2 on the medical benefit only; for pharmacy benefit the same product may be Step 3.	Step placement and required trials may differ by pharmacy vs medical benefit; follow the step definitions relevant to the benefit.	Refer to benefit‑specific notes in the prior authorization policy and include documentation of current therapy if claiming continuation (e.g., currently taking Stelara 45mg vial).

Continuation / Maintenance Therapy Criteria

Continuation therapy

Continuation/maintenance scenarios that may allow ongoing coverage of specified vial formulations or existing therapy.

Continuation option: Approval option exists for patients currently taking Stelara subcutaneous 45mg vial or ustekinumab subcutaneous 45mg vial (where applicable).

Applies when patient is already on the product; specific step/benefit notes: Stelara 45mg and 90mg syringes remain Step 1 Preferred; Stelara 45mg vial and ustekinumab 45mg vial have distinct Step placements and may be covered as continuation on the medical benefit.

Site of Care and Benefit Distinctions

Note

Medical‑benefit vs pharmacy‑benefit distinctions for certain vial presentations

Coverage differences exist between pharmacy and medical benefits for certain product presentations: for example, the ustekinumab (Janssen) 45mg vial is designated as a Step 2 product on the medical benefit but is Step 3 Non‑Preferred under the pharmacy benefit; confirm benefit-specific coverage when ordering for infusion/medical‑benefit settings.

Stelara SC 45mg vial may be covered as Step 2 on the medical benefit only; under the pharmacy benefit ustekinumab subcutaneous injection is Step 3 Non‑Preferred.
Refer to benefit-specific criteria and the Step table when requesting coverage for infusion center or medical‑benefit administration.

Biosimilar Positioning

Note

Biosimilars: no clinically meaningful differences; grouped by preference

Biosimilars are recognized as having no clinically meaningful differences from Stelara; the policy groups various ustekinumab biosimilars among preferred, non‑preferred, and non‑covered lists for step placement and coverage determinations.

Biosimilars share the same mechanism, route, dosage form, and strength as Stelara though inactive components may differ.
Refer to the policy's preferred/non‑preferred listing to determine which biosimilars are preferred or non‑preferred for step therapy.

Background

Ustekinumab subcutaneous products (originator and multiple biosimilars) are indicated for a variety of inflammatory conditions per product prescribing information. Biosimilars share the same mechanism of action, route, dosage form and strength as the reference product but may differ in inactive ingredients, which can affect tolerability or allergy risk according to the prescriber.

Within this program ustekinumab subcutaneous products are organized into formulary steps: Step 1 Preferred (e.g., Stelara SC 45mg and 90mg syringes, Imuldosa SC NDCs starting with 69448, Selarsdi SC, ustekinumab-ttwe SC, Yesintek SC), Step 2 and Step 3 Non-Preferred (with directed trials of one or all Preferred Products as specified), and a set of Non-Covered products for Employer Plans. Note that ustekinumab subcutaneous injection (Janssen Biotech) 45mg vial may be covered as a Step 2 product on the medical benefit but is a Step 3 Non-Preferred product for pharmacy benefit coverage; consult the criteria for benefit-specific rules.

OpenPayer

Ustekinumab Subcutaneous Products Preferred Specialty Management Policy for Legacy Prescription Drug List Plans