Pharmacy Prior Authorization Criteria

Ultomiris (ravulizumab-cwvz)

Indications for Prior Authorization

Ultomiris (ravulizumab-cwvz)

• For diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH)
  Indicated for the treatment of patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH).

• For diagnosis of Atypical Hemolytic Uremic Syndrome (aHUS)
  Indicated for the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

  Limitations of Use: Ultomiris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

• For diagnosis of Generalized Myasthenia Gravis (gMG)
  Indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

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

Criteria

Ultomiris

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH)

• Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
AND
• Patient is one month of age and older
AND
• Prescribed by or in consultation with a hematologist/oncologist

Ultomiris

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH)

• Patient demonstrates positive clinical response to therapy (e.g., hemoglobin stabilization, decrease in the number of red blood cell transfusions) to therapy

Ultomiris

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Atypical Hemolytic Uremic Syndrome (aHUS)

• Diagnosis of atypical hemolytic uremic syndrome (aHUS) [1]
AND
• Patient is one month of age and older
AND
• Prescribed by or in consultation with one of the following:
• Hematologist
• Nephrologist

Ultomiris

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Atypical Hemolytic Uremic Syndrome (aHUS)

• Patient demonstrates positive clinical response to therapy (e.g., normalization of platelet count, improvement in serum creatinine from baseline) to therapy

Ultomiris

Prior Authorization (Initial Authorization)

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

• Diagnosis of generalized myasthenia gravis (gMG)
AND
• 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
• Prescribed by or in consultation with a neurologist

Ultomiris

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response to therapy

Ultomiris

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

Ultomiris

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response to therapy

P & T Revisions

2024-05-01, 2024-02-08, 2023-11-30, 2023-02-22, 2022-10-06, 2022-09-07, 2022-02-11, 2021-07-07, 2021-05-25, 2021-02-26, 2020-12-02, 2020-02-05, 2019-11-07

References

1. Ultomiris Prescribing Information. Alexion Pharmaceuticals, Inc. Boston, MA. March 2024.
2. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology. 2016;87(4):419-25.

---

Revision History

• 2024-05-01: Added criteria for new indication of neuromyelitis optica spectrum disorder (NMOSD)
• 2024-02-08: 2024 UM Annual Review. Changed examples listed in reauth section of aHUS to normalization of platelet count and improvement in serum creatinine from baseline. Background updates
• 2023-11-30: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-02-22: 2023 UM Annual Review. No changes
• 2022-10-06: GPI Reclassification
• 2022-09-07: Added new indication for gMG. Updated background and references.
• 2022-02-11: 2022 UM Annual Review.
• 2021-07-07: Updated indication to expand age group for paroxysmal nocturnal hemoglobinuria.
• 2021-05-25: Addition of EHB formulary. No changes to criteria
• 2021-02-26: 2021 UM Annual Review.
• 2020-12-02: Added new GPIs to guideline.
• 2020-02-05: 2020 UM Annual Review. No changes to criteria.
• 2019-11-07: Updated criteria to include expanded indication of atypical Hemolytic Uremic Syndrome. Pending Dec 2019 P&T decision - SL - 11.07.19

---