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
• One of the following:
• Both of the following:
• Patient is anti-acetylcholine receptor (AChR) 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 (IVIG)
OR
• Both of the following:
• 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 (IVIG)
• Rituximab [3]
AND
• Prescribed by or in consultation with a neurologist

Rystiggo

Prior Authorization (Reauthorization)

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

• Documentation of positive clinical response to therapy

P & T Revisions

2024-08-02, 2023-09-13, 2023-09-21

References

1. Rystiggo Prescribing Information. UCB, Inc., Smyrna, GA. June 2024.
2. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology. 2016;87(4):419-25.
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

• 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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