Skyrizi® Intravenous (risankizumab-rzaa)

Skyrizi® Intravenous is covered only as induction therapy for FDA‑approved moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis in adults, with non‑FDA uses excluded and trials of mesalamine products or biosimilars not counting as adequate prior systemic therapy. Initial approval (3 months) requires age ≥18, gastroenterologist prescription/consultation, documentation of diagnosis and required prior‑therapy or disease‑specific criteria (e.g., prior systemic therapy trial or ileocolonic resection/fistulas/corticosteroid use or contraindication; for UC, prior systemic therapy or specified pouchitis treatments), and the specified induction dosing (Crohn’s: 600 mg IV at Weeks 0, 4, 8; UC: 1200 mg IV at Weeks 0, 4, 8).

"Non-countable trials (UC): "A trial of a mesalamine product or a biosimilar of the requested biologic do not count as systemic therapy for ulcerative colitis."