Vedolizumab (Entyvio) (Medicaid Expansion)

Policy ID: ME-I-9129-003-05

Section: Injections

Effective Date: July 01, 2023

Revised Date: June 24, 2025

Revision Effective Date: August 01, 2025

Last Reviewed: July 08, 2025

Applies To: Medicaid Expansion Only

Description

Vedolizumab (Entyvio) is a monoclonal antibody and integrin receptor antagonist used for the treatment of moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC) in adults. Vedolizumab (Entyvio) reduces chronically inflamed gastrointestinal tissue associated with UC/CD by binding to the α4β7 integrin receptor and inhibiting its interaction with mucosal address in cell adhesion molecule-1 (MAdCAM-1).

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

Vedolizumab (Entyvio) 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
ONE of the following:
- If a diagnosis of Crohn's Disease:
  - The individual must have failed a three-month trial of a TNF inhibitor [i.e., infliximab, certolizumab pegol, adalimumab] and ustekinumab, as evidenced by paid claims or printouts; and
  - The requested medication must be prescribed by, or in consult with, a gastroenterologist; or
- If a diagnosis of Ulcerative Colitis:
  - The individual must have failed a three-month trial of a TNF inhibitor [i.e., infliximab, adalimumab or golimumab] and 30-day trial with a JAK inhibitor (upadacitinib), as evidenced by paid claims or printouts; and
  - The requested medication must be prescribed by, or in consult with, a gastroenterologist.

Reauthorization Criteria

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

The individual has previously been approved for vedolizumab (Entyvio) 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 vedolizumab (Entyvio) 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

J3380

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

K50.90

K50.911

K50.912

K50.913

K50.914

K50.918

K50.919

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 5-23-2023 - Effective July 01, 2023

Adopted Medicaid Expansion specific policy

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

Updated two "and" to "or" in initial criteria

Internal Medical Policy Committee 01-14-2025 Effective March 01, 2025

Updated initial criteria required failed agents based on the DHHS PDL Version 2025.1

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

Updated initial criteria required based on the DHHS PDL Version 2025.3

Internal Medical Policy Committee 07-08-2025 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-9129-003-04

Section: Injections

Effective Date: July 01, 2023

Revised Date: March 09, 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

Vedolizumab (Entyvio) 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
ONE of the following:
- If a diagnosis of Crohn's Disease:
  - The individual must have failed a three-month trial of a TNF inhibitor [i.e., infliximab, certolizumab pegol, adalimumab], as evidenced by paid claims or printouts; and
  - The requested medication must be prescribed by, or in consult with, a gastroenterologist; or
- If a diagnosis of Ulcerative Colitis:
  - The individual must have failed a three-month trial of a TNF inhibitor [i.e., infliximab, adalimumab or golimumab] and 30-day trial with a JAK inhibitor (upadacitinib), as evidenced by paid claims or printouts; and
  - The requested medication must be prescribed by, or in consult with, a gastroenterologist.

Reauthorization Criteria

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

The individual has previously been approved for vedolizumab (Entyvio) 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

J3380

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

K50.90

K50.911

K50.912

K50.913

K50.914

K50.918

K50.919

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 5-23-2023 - Effective July 01, 2023

Adopted Medicaid Expansion specific policy

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

Updated two 'and' to 'or' in initial criteria

Internal Medical Policy Committee 01-14-2025 Effective March 01, 2025

Updated initial criteria required failed agents based on the DHHS PDL Version 2025.1

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

Updated initial criteria required based on the DHHS PDL Version 2025.3

Medical Policies Quick Search

Vedolizumab (Entyvio) (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