Pharmacy Prior Authorization Criteria

Imaavy (nipocalimab) - PA, NF

Indications for Prior Authorization

Imaavy (nipocalimab)

• For diagnosis of Generalized Myasthenia Gravis (gMG)
  Indicated for the treatment of generalized myasthenia gravis(gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Criteria

Imaavy

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:
• All 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)
AND
• Trial and failure, contraindication, or intolerance to BOTH of the following:
• Vyvgart or Vyvgart Hytrulo
• Rystiggo
OR
• All 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
• Trial and failure, contraindication (e.g., age) or intolerance to Rystiggo
AND
• Patient is 12 years of age or older
AND
• Prescribed by or in consultation with a neurologist

Imaavy

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response to therapy

Imaavy

Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming diagnosis of generalized myasthenia gravis (gMG)
AND
• One of the following:
• Submission of medical records (e.g., chart notes) and/or paid claims confirming ALL 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)
AND
• Trial and failure, contraindication, or intolerance to BOTH of the following:
• Vyvgart or Vyvgart Hytrulo
• Rystiggo
OR
• Submission of medical records (e.g., chart notes) and/or paid claims confirming ALL 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
• Trial and failure, contraindication (e.g., age) or intolerance to Rystiggo
AND
• Patient is 12 years of age or older
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

2025-10-02, 2025-07-02

References

1. Imaavy Prescribing Information. Janssen Biotech, Inc. Horsham, PA 19044. April 2025.
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

• 2025-10-02: Addition of trial and failure criteria and drug specific non formulary criteria.
• 2025-07-02: New program.

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