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). 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 for the treatment of Crohn's Disease (CD) when the following criteria are met:

• The individual has a diagnosis moderately to severely active CD and ONE of the following:
  • The individual has tried and had an inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine)) used in the treatment of CD for at least 3 months; or
  • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents 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
• Previous medication history indicates separate trials and failure of the two preferred biologic agents Humira (adalimumab) and Stelara (ustekinumab) or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to the preferred biologic agents; or
• Information has been provided that indicates the individual is currently being treated with vedolizumab (Entyvio) (starting on samples is not approvable); or
  
• The prescriber states the individual is currently being treated with vedolizumab (Entyvio) (starting on samples is not approvable) AND is at risk if therapy is changed; and
• The prescriber is a specialist in the area of the individual’s diagnosis or has consulted with a specialist in the area of the individual’s diagnosis; and
  
• ONE of the following:
  • The individual is NOT currently being treated with another biologic immunomodulator agent or Otezla; or
  • The individual is currently being treated with another biologic immunomodulator agent or Otezla AND will discontinue prior to starting the requested agent.

Vedolizumab (Entyvio) may be considered medically necessary for the treatment of Ulcerative Colitis (UC) when the following criteria are met:

• The individual is 18 years of age or older with moderately to severely active UC and ONE of the following:
  • The individual has tried and had an inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3 months; or
  • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents 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
    
• Previous medication history indicates a trial and failure of preferred biologic agent Humira (adalimumab) or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to the preferred biologic agent; or
• Information has been provided that indicates the individual is currently being treated with vedolizumab (Entyvio) (starting on samples is not approvable); or
  
• The prescriber states the individual is currently being treated with vedolizumab (Entyvio) (starting on samples is not approvable) AND is at risk if therapy is changed; and
• The prescriber is a specialist in the area of the individual’s diagnosis or has consulted with a specialist in the area of the individual’s diagnosis; and
  
• ONE of the following:
  • The individual is NOT currently being treated with another biologic immunomodulator agent or Otezla; or
  • The individual is currently being treated with another biologic immunomodulator agent or Otezla AND will discontinue prior to starting the requested agent.

Vedolizumab (Entyvio) for any other indication is considered experimental/investigational and therefore non-covered. cientific 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 approval process; and
• The provider has provided documentation that individual has demonstrated disease stability or beneficial response to therapy
  
  Reauthorization valid for 12 months.

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 a tumor necrosis factor (TNF) antagonist [e.g., adalimumab (Humira), golimumab (Simponi];or
• 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 (Entyvio); 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

Covered Diagnosis Codes for J3380

Professional Statements and Societal Positions Guidelines

NA

Rationale

NA