Tremfya (guselkumab) — Medica

Initial criteria

• age > 18 years
• EITHER patient has tried or is currently taking corticosteroids, or corticosteroids are contraindicated OR patient has tried one other conventional systemic therapy for Crohn’s disease OR patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas OR patient had ileocolonic resection
• prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

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

Approval duration

initial 6 months, reauth 1 year