Pharmacy Prior Authorization Criteria

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.

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 All indications listed above

• Patient demonstrates positive clinical response to therapy

P & T Revisions

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

References

1. Uplizna Prescribing Information. Horizon Therapeutics USA, Inc. Deerfield, IL. April 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.

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Revision History

• 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

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