CurrentBlue Cross Blue Shield - IowaPolicy 05.01.28

Ustekinumab (including biosimilars) coverage and prior authorization

Defines Wellmark BCBS Iowa coverage, prior authorization criteria, documentation, prescriber specialties, dosing/quantity limits, and billing codes for ustekinumab (including Otulfi preferred and specified non-preferred biosimilars) across plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyUstekinumab (including biosimilars) coverage and prior authorization

Policy CodePolicy 05.01.28

Change TypeRevised (April 2025)

Effective DateMay 1, 2025

Next Review Date

Key ActionSubmit prior authorization with required documentation (chart notes, BSA, medication history, response to prior therapies or clinical reasons to avoid) per indication; IV formulation only authorized for CD and UC.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and revised April 2025 with current effective date May 1, 2025.

4FDA-approved indications listed

12 monthsTypical authorization duration

TB within 12 moPre-initiation infectious disease screening

Post-limit availableDose escalation exception

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Coverage Summary

Policy ensures appropriate selection for ustekinumab therapy based on FDA labeling, clinical guidelines, and studies; Otulfi (ustekinumab-aauz) is the preferred product. Non-preferred products including Imuldosa, Pyzchiva, Selarsdi, Stelara, Steqeyma, Wezlana, and Yesintek are generally excluded from coverage unless a clinical exception is documented and justified. The policy scope covers FDA-approved indications across plaque psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), and ulcerative colitis (UC) with prior authorization, documentation, prescriber specialty, dosing, and TB screening requirements applied per indication.

General Covered Indications (must meet approval criteria)

Coverage provided for FDA-approved indications and compendial uses when all approval criteria are met and no contract exclusions apply.

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Initial Therapy Criteria (by indication)

Plaque psoriasis (PsO) - Initial authorization

Authorization of 12 months may be granted when ONE of the following is met for members ≥6 years:

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Psoriatic arthritis (PsA) - Initial authorization

Authorization of 12 months may be granted for members ≥6 years when ONE of the following is met:

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Crohn's disease (CD) - Initial/maintenance authorization

Authorization of 12 months may be granted for treatment of moderately to severely active Crohn's disease when criteria met; IV formulation only authorized for CD and UC.

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Ulcerative colitis (UC) - Initial/maintenance authorization

Authorization of 12 months may be granted for treatment of moderately to severely active ulcerative colitis when criteria met; IV formulation only authorized for CD and UC.

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Continuation / Renewal Criteria

Continuation/renewal criteria (all indications)

Authorization of 12 months may be granted for members who achieve or maintain positive clinical response.

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Non-covered / Not medically necessary

Ustekinumab is considered not medically necessary when:

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Required Documentation (by indication)

Documentation Required

TB screening documentation

Document a negative tuberculosis (TB) test (TST or IGRA) within 12 months prior to initiating ustekinumab for members who are naïve to biologic or targeted‑synthetic therapy. If the TB screening is positive, obtain further testing to exclude active disease (e.g., chest x‑ray); do not administer ustekinumab if active TB is present. If latent TB is identified, TB treatment must be started prior to initiation of ustekinumab.

Prior Authorization

Prior authorization required

Prior authorization is required. Submit a prior authorization request with the required documentation per indication, including chart notes/medical records showing impacted area(s) and BSA (if applicable), medication history and response to prior therapies, or documentation of clinical reasons to avoid therapies. The policy’s applicable HCPCS/J and Q‑codes should be used when reporting: J3358, J3357, Q9999, Q9996, Q9997, Q9998, Q5098, Q5099, Q5100, Q5137, Q5138, J3590, and J3490. Note: intravenous ustekinumab (J3358 and applicable IV Q‑codes) is only authorized for Crohn’s disease and ulcerative colitis.

Applicable Codes

Primary HCPCS/J-codes and biosimilar Q-codesHCPCSCovered

J3358	ustekinumab, for intravenous injection, 1 mg
J3357	ustekinumab, subcutaneous injection, 1 mg
Q9999	ustekinumab-aauz (Otulfi), biosimilar, 1 mg
Q9996	Pyzchiva (Ustekinumab-ttwe, biosimilar) for subcutaneous injection
Q9997	Pyzchiva (Ustekinumab-ttwe, biosimilar) for intravenous injection
Q9998	Selarsdi (Ustekinumab-aekn, biosimilar)
Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg (effective 7/1/25)
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg (effective 7/1/25)
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg (effective 7/1/25)
Q5137	Wezlana (Ustekinumab-aaub, biosimilar) for subcutaneous injection

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Primary HCPCS/J-codes and biosimilar Q-codesHCPCSCovered

J3358	ustekinumab, for intravenous injection, 1 mg
J3357	ustekinumab, subcutaneous injection, 1 mg
Q9999	ustekinumab-aauz (Otulfi), biosimilar, 1 mg
Q9996	Pyzchiva (Ustekinumab-ttwe, biosimilar) for subcutaneous injection
Q9997	Pyzchiva (Ustekinumab-ttwe, biosimilar) for intravenous injection
Q9998	Selarsdi (Ustekinumab-aekn, biosimilar)
Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg (effective 7/1/25)
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg (effective 7/1/25)
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg (effective 7/1/25)
Q5137	Wezlana (Ustekinumab-aaub, biosimilar) for subcutaneous injection

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Billing Rule

Quantity limits and dosing enforcement

Approvals may be subject to dosing limits per FDA labeling and accepted compendia. Follow the policy’s specified quantity limits by formulation, indication, weight, and maintenance schedule. The following billing codes are affected by these quantity limits and dosing enforcement: J3358, J3357, and Q9999. Post‑limit quantity exception criteria are available for plaque psoriasis (≥6 years) and Crohn’s disease to allow dose escalation for partial response, nonresponse, or loss of response.

Affected codes: J3358, J3357, Q9999
Quantity limits vary by formulation, indication, weight, and maintenance schedule (see policy)
Post‑limit exception available for Psoriasis (≥6 years) and Crohn’s disease

Denial Risk

Background & Definitions

Coverage is aligned with FDA-approved labeling and clinical guideline-based selection criteria; the policy requires documentation and prior authorization consistent with those sources. Otulfi (ustekinumab-aauz) is identified as the preferred ustekinumab product, while multiple biosimilars and non-preferred products are generally excluded from coverage unless a documented clinical exception supports their use. The policy references FDA indications (PsO, PsA, CD, UC), relevant dosing/quantity limits per labeling, and the requirement for TB screening and specialist involvement for initial approvals.

Term	Definition
BSA	Body surface area
PsO	Plaque psoriasis
PsA	Psoriatic arthritis
CD	Crohn's disease
UC	Ulcerative colitis

Policy Metadata & Thresholds

Revision History

April 2025reviewed

Policy reviewed April 2025.

April 2025revised

Policy revised April 2025.

May 1, 2025effectiveLatest

Current effective date May 1, 2025.