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 [e.g., prednisone], azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
OR
• Both of the following:
• Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids [e.g., prednisone], 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 [e.g., prednisone], azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
OR
• Both of the following:
• Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids [e.g., prednisone], 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
AND
• Requested medication is not being used in combination with any one of the following for the indication of Generalized Myasthenia Gravis (gMG):
• neonatal Fc Receptor (FcRn) blocker (e.g., Vyvgart, Vyvgart Hytrulo, Rystiggo)
• complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
• immune globulin (e.g., IVIG)

Imaavy

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 for the indication of Generalized Myasthenia Gravis (gMG):
• neonatal Fc Receptor (FcRn) blocker (e.g., Vyvgart, Vyvgart Hytrulo, Rystiggo)
• complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
• immune globulin (e.g., IVIG)

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 [e.g., prednisone], azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
OR
• Both of the following:
• Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids [e.g., prednisone], 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 [e.g., prednisone], azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
OR
• Both of the following:
• Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids [e.g., prednisone], 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
AND
• Requested medication is not being used in combination with any one of the following for the indication of Generalized Myasthenia Gravis (gMG):
• neonatal Fc Receptor (FcRn) blocker (e.g., Vyvgart, Vyvgart Hytrulo, Rystiggo)
• complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
• immune globulin (e.g., IVIG)

P & T Revisions

2026-01-26, 2025-12-12, 2025-10-02, 2025-07-02

References

1. Imaavy Prescribing Information. Janssen Biotech, Inc. Horsham, PA 19044. April 2025.
2. Alhaidar MK, Abumurad S, Soliven B, Rezania K. Current Treatment of Myasthenia Gravis. J Clin Med. 2022 Mar 14;11(6):1597.
3. 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.
4. Myasthenia Gravis Foundation of America. Myasthenia Gravis Treatments. Available at: https://myasthenia.org/myasthenia-gravis-treatments/. Accessed December 23, 2025.

---

Revision History

• 2026-01-26: 2026 Annual Review
• 2025-12-12: New strength GPI added. Added IL statute operational note.
• 2025-10-02: Addition of trial and failure criteria and drug specific non formulary criteria.
• 2025-07-02: New program.

---