Zymfentra (infliximab-dyyb subcutaneous injection) — Medica

Initial criteria

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

Reauthorization criteria

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

Approval duration

initial: 6 months; continuation: 1 year