Guselkumab

This policy covers guselkumab (Tremfya) treatment — specifically the IV induction regimen (200 mg IV at Weeks 0, 4, and 8) followed by subcutaneous maintenance (100 mg every 8 weeks or 200 mg every 4 weeks) — for adults with moderate-to-severely active ulcerative colitis (mMS 5–9, ES 2–3) and also addresses use for Crohn’s disease, plaque psoriasis, and psoriatic arthritis per FDA-approved indications. Coverage is limited to patients who meet the policy’s clinical criteria (e.g., inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, or prior biologics/JAK inhibitors), requires documented clinical response after the 12‑week IV induction to continue maintenance, prohibits concurrent biologic or JAK inhibitor therapy, treats IV use as experimental outside the specified UC induction regimen, and remains subject to the member’s benefit plan and other exclusions.

"Ulcerative colitis: Guselkumab (Tremfya®) may be considered medically necessary when all policy-specified criteria are met"