Pharmacy Prior Authorization Criteria

Rystiggo (rozanolixizumab)

Indications for Prior Authorization

Rystiggo (rozanolixizumab)

• For diagnosis of Generalized Myasthenia Gravis (gMG)
  Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Criteria

Rystiggo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Generalized Myasthenia Gravis (gMG)

• Diagnosis of generalized myasthenia gravis (gMG)
AND
• Both of the following:
• One of the following:
• Patient is anti-acetylcholine receptor (AChR) antibody positive
OR
• Patient is anti-muscle-specific tyrosine kinase (MuSK) antibody positive
AND
• One of the following: [2]
• Trial and failure, contraindication, or intolerance to two immunosuppressive therapies (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
OR
• Both of the following:
• Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Chronic plasmapheresis or plasma exchange (PE)
• Intravenous immunoglobulin (e.g., IVIG)
• Rituximab [3]
AND
• Prescribed by or in consultation with a neurologist
AND
• Requested medication is not being used in combination with any one of the following:
• Another neonatal Fc receptor (FcRn) blocker (e.g., Imaavy, Vyvgart, Vyvgart Hytrulo)
• Complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
• Immune globulin (e.g., IVIG)

Rystiggo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Generalized Myasthenia Gravis (gMG)

• Patient demonstrates positive clinical response to therapy
AND
• Requested medication is not being used in combination with any one of the following:
• Another neonatal Fc receptor (FcRn) blocker (e.g., Imaavy, Vyvgart, Vyvgart Hytrulo)
• Complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
• Immune globulin (e.g., IVIG)

P & T Revisions

2026-05-26, 2025-12-18, 2025-12-18, 2025-10-17, 2024-08-02, 2023-09-13, 2023-09-21

References

1. Rystiggo Prescribing Information. UCB, Inc., Smyrna, GA. March 2025.
2. Narayanaswami P, Sanders DB, Wolfe G, et al. International Consensus Guidance for Management of Myasthenia Gravis: 2020 Update. Neurology. 2021 Jan 19;96(3):114-122.
3. Alhaidar MK, Abumurad S, Soliven B, Rezania K. Current Treatment of Myasthenia Gravis. J Clin Med. 2022 Mar 14;11(6):1597.

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Revision History

• 2026-05-26: Minor editorial updates and addition of criteria to not take in combination with another FcRn blocker, complement inhibitor or IVIG
• 2025-12-18: No criteria changes
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-10-17: 2025 Annual Review. Add Rituximab as step through option for anti-MuSK. Rituximab has supported use in both anti-MuSK and anti-AChR antibody positive gMG. Update reauthorization criteria to standard language.
• 2024-08-02: Addition of new strengths (420mg/3mL, 560mg/4mL and 840mg/6mL) to guideline
• 2023-09-13: New Program for Rystiggo
• 2023-09-21: New Program

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