Tildrakizumab-asmn (Ilumya) (Medicaid Expansion)

Policy ID: ME-I-9199-003-04

Section: Injections

Effective Date: July 01, 2023

Revised Date: June 25, 2025

Revision Effective Date: August 01, 2025

Last Reviewed: July 08, 2025

Applies To: Medicaid Expansion Only

Description

Tildrakizumab-asmn (Ilumya ^TM ) is a humanized IgG1/k monoclonal antibody that selectively and specifically binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab (Ilumya) inhibits the release of proinflammatory cytokines and chemokines.

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.

Initial Criteria

Tildrakizumab (Ilumya) may be considered medically necessary when the following criteria are met:

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 [i.e., infliximab, certolizumab pegol, etanercept, adalimumab] and an Interleukin (IL)-17A Inhibitor [i.e., ixekizumab (Taltz), secukinumab (Cosentyx)] and an Interleukin (IL)-17A and IL-17F inhibitor [i.e., bimekizumab-bkzx (Bimzelx)] and an interleukin (IL)-23p19 inhibitor [ i.e., tildrakizumab-asmn (Ilumya), risankizumab-rzaa (Skyrizi), guselkumab (Tremfya)] , as evidenced by paid claims or printouts.

Reauthorization Criteria

The continues use of tildrakizumab (Ilumya) may be considered medically necessary when ALL of the following criteria are met:

The individual has previously been approved for tildrakizumab (Ilumya) through Blue Cross Blue Shield of North Dakota's precertification process; and
The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy; and
The individual must continue to meet applicable initial criteria.

The use of tildrakizumab (Ilumya) 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.

Procedure Code

J3245

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 Code

L40.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

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

Adopted Medicaid Expansion specific policy

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

Annual review no clinical content change

Internal Medical Policy Committee 3-11-2025 Effective May 01, 2025

Updated initial criteria required based on the DHHS PDL Version 2025.3

Internal Medical Policy Committee 7-08-2025 Effective August 01, 2025

Updated initial criteria required based on the DHHS PDL Version 2025.5

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-9199-003-03

Section: Injections

Effective Date: July 01, 2023

Revised Date: March 05, 2025

Revision Effective Date: May 01, 2025

Last Reviewed: March 11, 2025

Archived Date: July 31, 2025

Applies To: Medicaid Expansion Only

Description

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.

Initial Criteria

Tildrakizumab (Ilumya) may be considered medically necessary when the following criteria are met:

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 [i.e., infliximab, certolizumab pegol, etanercept, adalimumab] and an Interleukin (IL)-17A Inhibitor [i.e., ixekizumab (Taltz), secukinumab (Cosentyx)] and an Interleukin (IL)-17A and IL-17F inhibitor [i.e., bimekizumab-bkzx (Bimzelx)], as evidenced by paid claims or printouts.

Reauthorization Criteria

The continues use of tildrakizumab (Ilumya) may be considered medically necessary when ALL of the following criteria are met:

The individual has previously been approved for tildrakizumab (Ilumya) through Blue Cross Blue Shield of North Dakota's precertification process; and
The prescriber has provided documentation that the individual has demonstrated disease stability or beneficial response to therapy; and
The individual must continue to meet applicable initial criteria.

Procedure Code

J3245

Diagnosis Code

L40.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

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

Adopted Medicaid Expansion specific policy

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

Annual review no clinical content change

Internal Medical Policy Committee 3-11-2025 Effective May 01, 2025

Updated initial criteria required based on the DHHS PDL Version 2025.3

Medical Policies Quick Search

Tildrakizumab-asmn (Ilumya) (Medicaid Expansion)

Description

Policy Application

Criteria

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Diagnosis Code

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer