vedolizumab (Entyvio®)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • Crohn’s disease
  • Ulcerative colitis

Patients must meet the following criteria for the indications above:

  • Diagnosis of Ulcerative Colitis or Crohn`s Disease AND
  • Diagnosis confirmed by a gastroenterologist
    • Differential diagnosis made to rule out ischemic bowel disease, other inflammatory diseases, or irritable bowel disease
    • Diagnosis confirmed with radiography, endoscopy, and/or capsule endoscopy
    • Patient does not have perforation, abscess, or obstruction
  • For Induction:
    • Patient is not in remission AND
    •  Failure or clinically significant adverse effects to Humira® and Remicade® for Crohn's
    •  Failure or clinically significant adverse effects to Humira® and Remicade® for ulcerative colitis
  •  For Reauthorization:
    • Twelve-week Review: Chart notes documenting benefit of induction therapy. AND
    • Six-Month Review: Chart notes documenting benefit of maintenance and patient is not on oral maintenance steroids

Coverage is Not Authorized For:

  • Non-FDA approved indications, which are not listed in the WHA Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature
  • Combination therapy with TNF antagonists [eg. Humira®, Cimzia®, Simponi®, Remicade
  • Combination therapy with Tysabri®
  • Patients who have or have had progressive multifocal leukoencephalopathy (PML)

Dosing:

  • Induction: 300 mg IV at weeks 0, 2 and 6
  • Maintenance Beginning week 14, 300 mg IV q 8 weeks

 

Last review date: July 20, 2016