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Zymfentra (infliximab-dyyb subcutaneous injection – Celltrion)Cigna

Crohn’s disease

Initial criteria

  • Patient is 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 (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: azathioprine, 6-mercaptopurine, or methotrexate). Exception may be made if the patient has already tried at least one biologic other than the requested medication; OR c) Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR d) 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 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 (e.g., fecal or serum markers, imaging, endoscopic assessment, and/or reduced dose of corticosteroids); 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; renewal: 1 year