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Skyrizi Subcutaneous (on-body injector)Medica

Crohn’s disease

Initial criteria

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

Reauthorization criteria

  • Patient has been established on therapy for at least 6 months
  • Patient has experienced a beneficial clinical response from baseline assessed by at least one objective measure (e.g., fecal or serum markers, imaging, endoscopic assessment, or reduced corticosteroid dose); OR patient experienced improvement in at least one symptom such as decreased pain, fatigue, stool frequency, or blood in stool

Approval duration

Initial: 6 months; Reauthorization: 1 year