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ZymfentraMedical Mutual

Crohn’s disease

Initial criteria

  • Patient is age ≥ 18 years; AND
  • 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; AND
  • Patient meets ONE of the following: (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; OR (c) Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR (d) Patient had ileocolonic resection; AND
  • The medication is prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

  • Patient has been established on infliximab product therapy for at least 6 months; AND
  • Patient meets ONE of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline; OR (b) Compared with baseline, patient experienced an improvement in at least one symptom such as decreased pain, fatigue, stool frequency, and/or blood in stool

Approval duration

initial 6 months; reauth 1 year