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Omvoh (mirikizumab-mrkz) subcutaneous injectionMedica

Crohn’s disease

Initial criteria

  • Patient is age > 18 years
  • According to the prescriber, the patient will receive induction dosing with Omvoh intravenous within 3 months of initiating therapy with Omvoh subcutaneous
  • Patient meets ONE of the following: (a) Patient has tried or is currently taking corticosteroids, or corticosteroids are contraindicated; OR (b) Patient has tried one other conventional systemic therapy for Crohn’s disease such as azathioprine, 6-mercaptopurine, or methotrexate; OR (c) Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR (d) Patient had ileocolonic resection (to reduce Crohn’s disease recurrence)
  • Medication is prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

  • Patient has been established on Omvoh subcutaneous therapy for at least 6 months
  • Patient meets at least ONE of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (examples: fecal or serum markers, imaging, endoscopic assessment, 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; Reauthorization: 1 year