Tremfya (guselkumab) — Medica

Initial criteria

• Patient is age ≥ 18 years
• Medication is prescribed by or in consultation with a gastroenterologist

Reauthorization criteria

• Patient has been established on the requested drug for at least 6 months
• Patient meets at least ONE of the following: (a) When assessed by at least one objective measure, patient experienced a beneficial clinical response from baseline (e.g., fecal calprotectin, C-reactive protein, endoscopic assessment, or reduced corticosteroid dose); OR (b) Compared with baseline, patient experienced an improvement in at least one symptom (e.g., decreased pain, fatigue, stool frequency, or rectal bleeding)

Approval duration

initial: 6 months; reauth: 1 year