Ustekinumab IV (Medicaid Expansion)

Policy ID: ME-I-9037-002-08

Section: Injections

Effective Date: January 01, 2022

Revised Date: March 05, 2025

Revision Effective Date: May 01, 2025

Last Reviewed: March 11, 2025

Applies To: Medicaid Expansion Only

Description

Ustekinumab is a human monoclonal antibody. It is directed against interleukin 12 and interleukin-23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders.

The intravenous formulation may be covered under the medical benefit. The subcutaneous formulation may be covered under the pharmacy benefit.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The use of ustekinumab IV may be considered medically necessary when the following criteria are met:

For Crohn's Disease (CD):

The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
The individual must have failed a 3-month trial of an TNF inhibitor, Entyvio, an Interleukin (IL)-23p19 Inhibitor, and a 30-day trial with a JAK inhibitor, as evidenced by paid claims or printouts.

For Ulcerative Colitis (UC):

The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
The individual must have failed a 3-month trial of a TNF inhibitor, Entyvio, an Interleukin (IL)-23p19 Inhibitor and a 30-day trial with a JAK inhibitor, as evidenced by paid claims or pharmacy printouts.

NOTE: If approved, ustekinumab IV will be allowed as a single intravenous infusion.

The use of ustekinumab IV for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Ustekinumab IV for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

J3358

Q5138

Q9997

Q9998

Q9999

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

K50.00

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.10

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.80

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K51.00

K51.011

K51.012

K51.013

K51.014

K51.018

K51.019

K51.20

K51.211

K51.212

K51.213

K51.214

K51.218

K51.219

K51.30

K51.311

K51.312

K51.313

K51.314

K51.318

K51.319

K51.40

K51.411

K51.412

K51.413

K51.414

K51.418

K51.419

K51.50

K51.511

K51.512

K51.513

K51.514

K51.518

K51.519

K51.80

K51.811

K51.812

K51.813

K51.814

K51.818

K51.819

K51.90

K51.911

K51.912

K51.913

K51.914

K51.918

K51.919

Professional Statements and Societal Positions Guidelines

α4 Integrin Inhibitors

TYSABRI (natalizumab)

α4β7 Integrin Inhibitors

ENTYVIO (vedolizumab)

Janus Kinase (JAK) inhibitors

RINVOQ ER (upadacitinib)

Interleukin (IL) 12/IL-23 Inhibitors

SELARSDI (ustekinumab-aekn)
STELARA (ustekinumab)
STEQEYMA (ustekinumab-stba)
ustekinumab-ttwe
WEZLANA (ustekinumab-auub)
YESINTEK (ustekinumab-kfce)

Interleukin (IL)-23p19 Inhibitor

OMVOH (mirikizumab)
SKYRIZI (risankizumab-rzaa)
TREMFYA (guselkumab)

TNF Inhibitors

adalimumab and biosimilar agents
CIMZIA (certolizumab)
infliximab and biosimilar agents
SIMPONI (golimumab)

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy Effective January 01, 2022

Internal Medical Policy Committee 5-24-2022 Changed second UC criteria to 'The individual must have had a 30-day trial of a preferred agent or a TNF inhibitor, as evidenced by paid claims or pharmacy printouts.' from 'The individual must have had a 30-day trial of each preferred biologic agent, as evidenced by paid claims or pharmacy printouts.' based on Version 2022.4 of the PDL

Internal Medical Policy Committee 5-23-2023 - Effective June 01, 2023

Updated CD and UD criteria based on Version 2023.2 of the PDL

Internal Medical Policy Committee 1-16-2024 Effective January 01, 2024

Removed subcutaneous formulation of ustekinumab (Stelara) as this is part of policy ME-I-9015-001

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Added new code, Q5138 for ustekinumab-auub (Wezlana) intravenous to the policy
Updated policy title to remove 'Stelara'

Internal Medical Policy Committee 11-19-2024 Effective December 01, 2024

Updated criteria based on the DHHS PDL Version 2024.6

Internal Medical Policy Committee 11-19-2024 Effective January 01, 2025

Added new code, Q9997, to the policy

Internal Medical Policy Committee 03-11-2025 Effective April 01, 2025

Added new codes Q9998 and Q9999 to the policy
Updated criteria based on the DHHS PDL Version 2025.3

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: ME-I-9037-002-07

Section: Injections

Effective Date: January 01, 2022

Revised Date: November 18, 2024

Revision Effective Date: January 01, 2025

Last Reviewed: November 19, 2024

Archived Date: April 30, 2025

Applies To: Medicaid Expansion Only

Description

The intravenous formulation may be covered under the medical benefit. The subcutaneous formulation may be covered under the pharmacy benefit.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The use of ustekinumab IV may be considered medically necessary when the following criteria are met:

For Crohn's Disease (CD):

The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
The individual has failed a 3-month trial of an TNF inhibitor, Rinvoq ER, Entyvio and Skyrizi, as evidenced by paid claims or printouts.

For Ulcerative Colitis (UC):

The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route); and
The individual must have failed a 3-month trial of a TNF inhibitor, Entyvio, and Skyrizi, as evidenced by paid claims or pharmacy printouts.

NOTE: If approved, ustekinumab IV will be allowed as a single intravenous infusion.

Ustekinumab IV for any other indication is considered experimental/investigational and therefore non-covered. Scientific evidence has not established the effectiveness for any other indication.

Procedure Codes

J3358

Q5138

Q9997

Diagnosis Codes

K50.00

K50.011

K50.012

K50.013

K50.014

K50.018

K50.019

K50.10

K50.111

K50.112

K50.113

K50.114

K50.118

K50.119

K50.80

K50.811

K50.812

K50.813

K50.814

K50.818

K50.819

K51.00

K51.011

K51.012

K51.013

K51.014

K51.018

K51.019

K51.20

K51.211

K51.212

K51.213

K51.214

K51.218

K51.219

K51.30

K51.311

K51.312

K51.313

K51.314

K51.318

K51.319

K51.40

K51.411

K51.412

K51.413

K51.414

K51.418

K51.419

K51.50

K51.511

K51.512

K51.513

K51.514

K51.518

K51.519

K51.80

K51.811

K51.812

K51.813

K51.814

K51.818

K51.819

K51.90

K51.911

K51.912

K51.913

K51.914

K51.918

K51.919

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-23-2021 Adopted Medicaid Expansion specific policy Effective January 01, 2022

Internal Medical Policy Committee 5-23-2023 - Effective June 01, 2023

Updated CD and UD criteria based on Version 2023.2 of the PDL

Internal Medical Policy Committee 1-16-2024 Effective January 01, 2024

Removed subcutaneous formulation of ustekinumab (Stelara) as this is part of policy ME-I-9015-001

Internal Medical Policy Committee 5-14-2024 Effective July 01, 2024

Added new code, Q5138 for ustekinumab-auub (Wezlana) intravenous to the policy
Updated policy title to remove 'Stelara'

Internal Medical Policy Committee 11-19-2024 Effective December 01, 2024

Updated criteria based on the DHHS PDL Version 2024.6

Internal Medical Policy Committee 11-19-2024 Effective January 01, 2025

Added new code, Q9997, to the policy

Medical Policies Quick Search

Ustekinumab IV (Medicaid Expansion)

Description

Policy Application

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Procedure Codes

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer