Omvoh (mirikizumab-mrkz) subcutaneous injection — Medica
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