WHA
 

Uplizna (inebilizumab-cdon)

Indications for Prior Authorization

Uplizna (inebilizumab-cdon)
  • For diagnosis of Neuromyelitis Optica Spectrum Disorder (NMOSD)
    Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

  • For diagnosis of Immunoglobulin G4-Related Disease (IgG4-RD)
    Indicated for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

  • 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

Uplizna

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • Diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
    • AND
  • Patient is anti-aquaporin-4 (AQP4) antibody positive
    • AND
  • Prescribed by or in consultation with one of the following:
    • Neurologist
    • Ophthalmologist
    AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to rituximab
      • OR
    • For continuation of prior therapy
Uplizna

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Immunoglobulin G4-Related Disease (IgG4-RD)

  • Diagnosis of Immunoglobulin G4-Related Disease (IgG4-RD)
    • AND
  • Presence of disease involving two or more organ systems or sites (e.g., Pancreas, Submandibular gland, Lymph node(s), Kidneys, Bile Duct, Lungs or Lacrimal glands)
    • AND
  • One of the following: [3]
    • Patient is currently being treated with a glucocorticoid (e.g., prednisone, methylprednisolone)
      • OR
    • Trial and failure, contraindication or intolerance to a glucocorticoid (e.g., prednisone, methylprednisolone)
Uplizna

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Neuromyelitis Optica Spectrum Disorder (NMOSD), Immunoglobulin G4-Related Disease (IgG4-RD)

  • Patient demonstrates positive clinical response to therapy
Uplizna

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: [4]
        • 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 [4-5]
      OR
    • Both of the following:
      • Patient is anti-muscle-specific tyrosine kinase (MuSK) antibody positive
        • AND
      • One of the following: [4]
        • 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 [4-5]
    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., Imaavy, Rystiggo)
    • complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
    • immune globulin (e.g., IVIG)
Uplizna

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., Imaavy, Rystiggo)
    • complement inhibitor (e.g., Soliris, Ultomiris, Zilbrysq)
    • immune globulin (e.g., IVIG)

  • Guideline ID
    GL-483928

  • Formulary
    Premium

  • Effective date
    Apr 1, 2026

  • P&T approval date
    Aug 13, 2020

P & T Revisions

1970-01-01, 2025-12-18, 2025-12-18, 2025-05-09, 2024-06-05, 2023-10-26, 2023-06-07, 2022-06-02, 2021-06-03, 2021-01-06, 2020-07-29

  1. Uplizna Prescribing Information. Horizon Therapeutics USA, Inc. Deerfield, IL.December 2025
  2. Stone, John H., et al. “Inebilizumab for Treatment of IgG4-Related Disease.” New England Journal of Medicine, vol. 392, no. 12, 14 Nov. 2024, https://doi.org/10.1056/nejmoa2409712.
  3. Khosroshahi, A., Wallace, Z.S., Crowe, J.L., Akamizu, T., Azumi, A., Carruthers, M.N., Chari, S.T., Della-Torre, E., Frulloni, L., Goto, H., Hart, P.A., Kamisawa, T., Kawa, S., Kawano, M., Kim, M.H., Kodama, Y., Kubota, K., Lerch, M.M., Löhr, M., Masaki, Y., Matsui, S., Mimori, T., Nakamura, S., Nakazawa, T., Ohara, H., Okazaki, K., Ryu, J.H., Saeki, T., Schleinitz, N., Shimatsu, A., Shimosegawa, T., Takahashi, H., Takahira, M., Tanaka, A., Topazian, M., Umehara, H., Webster, G.J., Witzig, T.E., Yamamoto, M., Zhang, W., Chiba, T. and Stone, J.H. (2015), International Consensus Guidance Statement on the Management and Treatment of IgG4-Related Disease. Arthritis & Rheumatology, 67: 1688-1699.
  4. 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.
  5. Alhaidar MK, Abumurad S, Soliven B, Rezania K. Current Treatment of Myasthenia Gravis. J Clin Med. 2022 Mar 14;11(6):1597.
  6. Myasthenia Gravis Foundation of America. Myasthenia Gravis Treatments. Available at: https://myasthenia.org/myasthenia-gravis-treatments/. Accessed December 23, 2025.
  • 2025-12-18: No criteria changes
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-05-09: Updated guideline with new FDA-approved indication for IgG4-RD.
  • 2024-06-05: Annual review: Background and formatting updates.
  • 2023-10-26: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-06-07: Annual review: No updates required.
  • 2022-06-02: Annual review: Updated background.
  • 2021-06-03: Annual review: Background updates.
  • 2021-01-06: Updated prescriber requirement and added embedded step.
  • 2020-07-29: New program