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