Rystiggo®
Drug - Rystiggo® (rozanolixizumab-noli) [UCB Inc.]
January 2025
Therapeutic area - Immunomodulators, Miscellaneous
Initial approval criteria
- Patient is ≥ 18 years of age; AND
- Patient weighs ≥ 35 kg; AND
- Patient has a clinical diagnosis of generalized myasthenia gravis (gMG) with a Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV disease; AND
- Patient has a positive serologic test for anti-acetylcholine receptor (AChR) antibodies or anti-muscle specific kinase protein (MuSK) antibodies; AND
- Physician has assessed objective signs of neurological weakness and fatiguability on a baseline neurological examination (e.g., Quantitative Myasthenia Gravis [QMG] score); AND
- Patient has a baseline MG-Activities of Daily Living (MG-ADL) total score ≥ 3; AND
- For patients with AChR-positive disease with thymomas OR nonthymomatous patients who are ≤ 50 years of age, patient has had a thymectomy; AND
- One of the following applies:
- For patients with AChR+ disease, the patient had an inadequate response to a trial of concurrent use with ≥ 2 immunosuppressive therapies (e.g., corticosteroids plus an immunosuppressant such as azathioprine, cyclosporine, mycophenolate) for ≥ 1 year; OR
- For patients with MuSK+ disease, the patient had an inadequate response to a trial of immunosuppressive therapy (e.g., corticosteroids, azathioprine, mycophenolate) and rituximab for ≥ 1 year; OR
- Patient required ≥ 1 acute or chronic treatment with plasmapheresis or plasma exchange (PE) or intravenous immunoglobulin (IVIG) in addition to their background therapy above; AND
- Patient does NOT have a deficiency of immunoglobulin G (IgG) necessitating supplementation with IgG; AND
- Patient does NOT have an active infection, including clinically important localized infections; AND
- Patient is up to date with all vaccinations in accordance with current vaccination guidelines, and live-attenuated or live vaccines will NOT be administered during treatment; AND
- Rozanolixizumab-noli will NOT be used in combination with other immunomodulatory biologic therapies (e.g., efgartigimod alfa-fcab, efgartigimod alfa/hyaluronidase-qvfc, rituximab, eculizumab, ravulizumab, pegcetacoplan, satralizumab, inebilizumab); AND
- Patient will avoid, or use with caution, medications known to worsen or exacerbate symptoms of MG (e.g., certain antibiotics, beta-blockers, botulinum toxins, hydroxychloroquine).
- Initial approval is for 4 months
Renewal criteria
- Patient must continue to meet the above criteria; AND
- Patient must have disease improvement as indicated by a reduction in MG-ADL total score of ≥ 1 point from baseline*; AND
- Patient has experienced improvement in muscle strength testing with fatigue maneuvers as evidenced on neurologic examination when compared to baseline; AND
- Patient requires continuous treatment, after an initial beneficial response, due to new or worsening disease activity (Note: a minimum of 63 days must have elapsed from the start of the previous treatment cycle); AND
- Patient has not experienced unacceptable toxicity from the drug (e.g., infection, severe hypersensitivity reactions, aseptic meningitis).
- Renewal approval is for 6 months
*May substitute an improvement of ≥ 1 point from baseline in the Quantitative Myasthenia Gravis (QMG) total score sustained, if available.
Quantity limits
- 36 mL (18 vials) per 63 days (3 vials per week for 6 doses per 63 days)
- Maximum recommended dosage: 840 mg/6 mL per week for 6 doses per 63 days
- Patient’s most current weight (in kg) must be submitted at time of request
Billing for Ryplazim
Rystiggo must be billed as a medical claim
Questions
Provider Call Center (844) 575-7887