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 addressin cell adhesion molecule-1 (MAdCAM-1). This results in the inhibition of memory T-lymphocyte movement across the endothelium of the inflamed gastrointestinal tissues.

Criteria

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

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Vedolizumab (Entyvio) may be considered medically necessary when an individual meets the criteria for ANY ONE of the following indications:

Crohn’s Disease (CD):

• • The individual is 18 years of age or older with moderately to severely active CD; and
  • Any ONE of the following:
    • The individual is currently pregnant; or
    • Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
    • The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
    • The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, aminosalicylates, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], mesalamine, methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months or
      
    • The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD or
    • The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of CD; and
  • The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for CD, UC) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
  • The individual will NOT be using vedolizumab (Entyvio) with another biologic immunomodulator agent.

Ulcerative Colitis (UC):

• • The individual is 18 years of age or older with moderately to severely active UC; and
  • Any ONE of the following:
    • The individual is currently pregnant
    • Information has been provided that indicates the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; or
    • The prescriber states the individual has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed; or
    • The individual has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, metronidazole, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3-months; or
    • The individual has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC; or
    • The individual's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence for the treatment of UC; and
  • The prescriber is a specialist in the area of the individual’s diagnosis (e.g., gastroenterologist for CD, UC) or the prescriber has consulted with a specialist in the area of the individual’s diagnosis; and
  • The individual will NOT be using vedolizumab (Entyvio) with another biologic immunomodulator agent.

Vedolizumab (Entyvio) 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 

Reauthorization Criteria

Continuation of therapy with vedolizumab (Entyvio) may be considered medically necessary when the following criteria are met:

• The individual has been previously 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 will NOT be using the requested agent with another biologic immunomodulator agent.
  

Vedolizumab (Entyvio) 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 

Vedolizumab (Entyvio) is considered not medically necessary for an individual with ANY of the following:

• In combination with natalizumab (Tysabri); or
• Uncontrolled active, severe infections including but not limited to: sepsis, tuberculosis, cytomegaloviral colitis, giardiasis, listeria meningitis, salmonella sepsis, anal abscess etc.; or
• Individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC) recommended equivalent to evaluate for latent tuberculosis prior to initiating vedolizumab; or
• New or worsening neurological signs or symptoms of John Cunningham virus (JCV) infection or risk of progressive multifocal leukoencephalopathy (PML).

Vedolizumab (Entyvio) 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 

NOTE:In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Original Effective Date July 1, 2018

Internal Medical Policy Committee 3-16-2020 Updated criteria to match other biologic immunomodulator criteria, update preferred products for UC, added reauthorization criteria

Internal Medical Policy Committee 5-19-2020 Removed preferred product language

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.