Rozanolixixumab-noli

Covers rozanolixizumab‑noli (Rystiggo) for treatment of generalized myasthenia gravis (gMG) in adults (≥18) with MGFA class II–IVa who are anti‑AChR or anti‑MuSK antibody positive, have impaired activities of daily living (MG‑ADL ≥3 with ≥3 non‑ocular points), and a baseline serum IgG ≥5.5 g/L. Coverage requires specified prior therapy trials (anti‑AChR patients must have inadequate response/intolerance/contraindication to an acetylcholinesterase inhibitor plus ≥1 immunosuppressive; anti‑MuSK patients must have failed ≥1 immunosuppressive), is limited to FDA‑approved indications when criteria are met, and reauthorization requires ≥2‑point improvement in MG‑ADL; patients who are antibody‑negative, <18 years, have IgG <5.5 g/L, or do not meet dosing/authoritative‑source requirements are excluded.

"Therapies are covered when proven effective for the relevant diagnosis or procedure based on generally accepted standards of practice."