ModifiedEmblemHealthPolicy MG.MM.PH.106

Ustekinumab IV solution and SC injection

Medical policy governing prior authorization, coverage criteria, dosing limits, renewal, and exclusions for ustekinumab (Stelara) intravenous induction and subcutaneous maintenance for multiple indications for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyUstekinumab IV solution and SC injection

Policy CodePolicy MG.MM.PH.106

Change TypeMultiple: product additions, code/NDC updates, criteria additions

Effective Date

Next Review DateMay 30, 2025

Key ActionSubmit prior authorization with documentation that universal baseline criteria and indication-specific trials/response requirements are met, and use the route-specific billing code (J3358 for IV; J3357 for SC) and appropriate NDC.

SourceLink

POLICY UPDATE CHANGES

Wezlana intravenous, Selarsdi, Steqeyma, Yesintek, Ustekinumab-ttwe, and unbranded ustekinumab intravenous products were added with the same criteria as other ustekinumab IV products.

Policy name changed from Stelara to Ustekinumab; Otulfi added along with dosing limits/charts/length of authorization and criteria.

Discontinue use of J3590 for unclassified biologics on 07/01/2025 noted (Imuldosa, Steqeyma/Ustekinumab-stba, and Yesintek ONLY).

Policy name changed from Stelara to Ustekinumab; Otulfi was added to the policy including dosing limits, charts, and length of authorization, and Otulfi NDCs and J-code were added.

Criteria for Crohn's Disease were added to include high-risk disease requiring biologic therapy or patients already established on biologic/targeted synthetic therapy.

Added Stelara SC to policy, dosing limits, dosing chart, length of authorization and criteria; added J3357 and SC formulation NDCs.

Multiple ICD-10 codes for ulcerative colitis (K51.* series) were added/expanded to the policy.

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Coverage Criteria and Dosing

Universal Initial Criteria

Covered when ALL of the following universal criteria are met:

Universal Initial Criteria: Patient is 18 years or older (unless otherwise specified); AND patient has been evaluated and screened for the presence of latent TB infection prior to initiating treatment; AND patient is free of any clinically important active infections; AND therapy will not be administered concurrently with live vaccines; AND patient is not on concurrent treatment with a TNF-inhibitor, biologic response modifier, or other non-biologic agent (e.g., apremilast, tofacitinib, baricitinib); AND physician has assessed baseline disease severity utilizing an objective measure/tool.

Crohn's Disease (IV induction)