This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Vedolizumab may be considered medically necessary for moderate to severe disease activity of ulcerative colitis (UC) when ONE of the following criteria is met: 

• Treatment with infliximab (Remicade) for at least eight weeks was ineffective, not tolerated, or is contraindicated; or
• Treatment with adalimumab (Humira) for at least eight weeks was ineffective, not tolerated, or is contraindicated. 

For new or current members established on vedolizumab therapy, for the treatment of moderate to severe UC, continued treatment may be considered medically necessary.

Vedolizumab may be considered medically necessary for treatment of moderate to severe disease activity of Crohn's disease (CD) (e.g., esophageal, gastroduodenal, perianal, or rectal disease; history of colonic or small-bowel resection) when ONE of the following criteria is met:  

• Treatment with infliximab (Remicade) for at least eight weeks was ineffective, not tolerated, or is contraindicated; or
• Treatment with adalimumab (Humira) for at least twelve weeks was ineffective, not tolerated, or is contraindicated.  

For new or current members established on vedolizumab therapy, for the treatment of moderate to severe Crohn’s disease, continued treatment may be considered medically necessary. 

Vedolizumab 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), Simponi (golimumab)]; or  In combination with an immunomodulatory drug, such as natalizumab (Tysabri); or
• Tuberculosis or active, serious infection or a history of recurrent infections; 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 for any other indication is considered experimental/investigational and, therefore, non-covered. 

Intravenous Vedolizumab (Entyvio) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

09/2015, New Policy for Vedolizumab (Entyvio®) to Treat Ulcerative Colitis and Crohn’s Disease

• Link to Diagnosis Codes

• Link to References