Risankizumab-rzaa (Skyrizi) IV (Medicaid Expansion)

Policy ID: ME-I-9025-001-04

Section: Injections

Effective Date: January 01, 2022

Revised Date: October 21, 2024

Revision Effective Date: December 01, 2024

Last Reviewed: November 19, 2024

Applies To: Medicaid Expansion Only

Description

Risankizumab-rzaa (Skyrizi ^® ) is an interleukin-23 antagonist that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

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 risankizumab-rzaa (Skyrizi) IV may be considered medically necessary when the following criteria are met:

Crohn's Disease

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 three (3)-month trial of a TNF Inhibitor (infliximab, adalimumab, certolizumab pegol, etanercept), as evidenced by paid claims or pharmacy printouts.

Ulcerative Colitis

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 three (3)-month trial of a TNF inhibitor and Entyvio, as evidenced by paid claims or pharmacy printout.

If approved, risankizumab-rzaa (Skyrizi) IV will be allowed as three (3) intravenous infusions over 12 weeks.

Risankizumab-rzaa (Skyrizi) 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.

Procedure Code

J2327

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

K50.10

K50.111

K50.112

K50.113

K50.114

K50.80

K50.811

K50.812

K50.813

K50.814

K50.90

K50.911

K50.912

K50.913

K50.914

K51.00

K51.011

K51.012

K51.013

K51.512

K51.812

K51.813

K51.814

K51.818

K51.819

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- EffectiveJanuary 01, 2022

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria; and
Updated reauthorization criteria; and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 - Effective December 1, 2023

Added code J2327; and
Updated TNF Inhibitor trial information

Internal Medical Policy Committee 9-17-2024 Effective October 01, 2024

Added criteria for ulcerative colitis indication

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

Updated criteria for ulcerative colitis indication to add 'The individual must have failed a three (3)-month trial of a TNF inhibitor and Entyvio, as evidenced by paid claims or pharmacy printout' based on the DHHS PDL Version 2024.6

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-9025-001-03

Section: Injections

Effective Date: January 01, 2022

Revised Date: September 13, 2024

Revision Effective Date: October 01, 2024

Last Reviewed: September 17, 2024

Archived Date: November 30, 2024

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 risankizumab-rzaa (Skyrizi) IV may be considered medically necessary when the following criteria are met:

Crohn's Disease

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 three (3)-month trial of a TNF Inhibitor (infliximab, adalimumab, certolizumab pegol, etanercept), as evidenced by paid claims or pharmacy printouts.

Ulcerative Colitis

The individual must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route)

If approved, risankizumab-rzaa (Skyrizi) IV will be allowed as three (3) intravenous infusions over 12 weeks.

Procedure Code

J2327

Diagnosis Codes

K50.00

K50.011

K50.012

K50.013

K50.014

K50.10

K50.111

K50.112

K50.113

K50.114

K50.80

K50.811

K50.812

K50.813

K50.814

K50.90

K50.911

K50.912

K50.913

K50.914

K51.00

K51.011

K51.012

K51.013

K51.512

K51.812

K51.813

K51.814

K51.818

K51.819

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- EffectiveJanuary 01, 2022

Internal Medical Policy Committee 11-29-2022 - Effective January 1, 2023

Updated initial criteria; and
Updated reauthorization criteria; and
Updated experimental/investigational statement

Internal Medical Policy Committee 11-15-2023 - Effective December 1, 2023

Added code J2327; and
Updated TNF Inhibitor trial information

Internal Medical Policy Committee 9-17-2024 Effective October 01, 2024

Added criteria for ulcerative colitis indication

Medical Policies Quick Search

Risankizumab-rzaa (Skyrizi) IV (Medicaid Expansion)

Description

Policy Application

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Policy Application

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer