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Entyvio (vedolizumab subcutaneous injection – Takeda)Cigna

Crohn’s disease

Initial criteria

  • Patient is age ≥ 18 years; AND
  • According to the prescriber, the patient is currently receiving Entyvio intravenous or will receive induction dosing with Entyvio intravenous within 2 months of initiating therapy with Entyvio subcutaneous; AND
  • Patient meets ONE of the following (a, b, c, or d):
  • a) Patient has tried or is currently taking systemic corticosteroids, or corticosteroids are contraindicated; OR
  • b) Patient has tried one conventional systemic therapy for Crohn’s disease (examples include azathioprine, 6-mercaptopurine, or methotrexate); OR
  • c) Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR
  • d) Patient had ileocolonic resection (to reduce the chance of Crohn’s disease recurrence); AND
  • The medication is prescribed by or in consultation with a gastroenterologist.

Reauthorization criteria

  • Patient has been established on Entyvio subcutaneous or intravenous for at least 6 months; AND
  • Patient meets at least ONE of the following (a or b):
  • a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples include fecal lactoferrin, fecal calprotectin, C-reactive protein, imaging, endoscopic assessment, and/or reduced corticosteroid dose); OR
  • b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, and/or blood in stool).

Approval duration

Initial: 6 months; Reauth: 1 year