Tremfya (guselkumab subcutaneous injection) — Cigna

Initial criteria

• Patient age > 18 years; AND
• Patient meets ONE of the following (a, b, c, or d): 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 (e.g., azathioprine, 6-mercaptopurine, or methotrexate); OR c) Patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas; OR d) Patient had ileocolonic resection (to reduce chance of Crohn’s recurrence); AND
• Medication prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

• Patient has been established on therapy for at least 6 months; AND
• Patient meets ONE of the following: a) Beneficial clinical response from baseline demonstrated by at least one objective measure (e.g., fecal markers, serum markers, imaging, endoscopy, or reduced corticosteroid dose); OR b) Improvement versus baseline in at least one symptom such as decreased pain, fatigue, stool frequency, or blood in stool

Approval duration

initial 6 months, reauth 1 year