Pharmacy Prior Authorization Criteria

Soliris (eculizumab)

Indications for Prior Authorization

Soliris (eculizumab)

• For diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH)
  Indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

• For diagnosis of Atypical Hemolytic Uremic Syndrome (aHUS)
  Indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

  Limitations of Use: Soliris 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 (NMOSD)
  Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

Criteria

Soliris

Prior Authorization (Initial Authorization)

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

• Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)
AND
• Trial and failure, contraindication, or intolerance to Ultomiris (ravulizumab)
AND
• Prescribed by or in consultation with a hematologist/oncologist

Soliris

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response (e.g., hemoglobin stabilization, decrease in the number of red blood cell transfusions) to therapy
AND
• Trial and failure, contraindication, or intolerance to Ultomiris (ravulizumab)

Soliris

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)
AND
• Trial and failure, contraindication, or intolerance to Ultomiris (ravulizumab)
AND
• Prescribed by or in consultation with one of the following:
• Hematologist
• Nephrologist

Soliris

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response (e.g., increase in mean platelet counts, hematologic normalization) to therapy
AND
• Trial and failure, contraindication, or intolerance to Ultomiris (ravulizumab)

Soliris

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
• Trial and failure, contraindication, or intolerance to one of the following:
• Ultomiris (ravulizumab)
• Vyvgart (efgartigimod)
AND
• One of the following: [2, 3]
• 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

Soliris

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response to therapy
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Ultomiris (ravulizumab)
• Vyvgart (efgartigimod)

Soliris

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
• Trial and failure, contraindication, or intolerance to Ultomiris (ravulizumab)
AND
• Prescribed by or in consultation with one of the following:
• Neurologist
• Ophthalmologist

Soliris

Prior Authorization (Reauthorization)

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

• Patient demonstrates positive clinical response to therapy
AND
• Trial and failure, contraindication, or intolerance to Ultomiris (ravulizumab)

P & T Revisions

2025-01-13, 2024-04-23, 2024-01-05, 2023-01-25, 2022-10-13, 2022-09-07, 2022-01-18, 2021-09-27, 2021-05-26, 2021-05-25, 2021-01-21, 2021-01-05, 2020-01-10, 2019-11-07, 2019-09-03

References

1. Soliris Prescribing Information. Alexion Pharmaceuticals, Inc. Boston, MA. September 2024.
2. Howard JF Jr, Utsugisawa K, Benatar M, et al. Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017;16(12):976-986.
3. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology. 2016;87(4):419-25.

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Revision History

• 2025-01-13: 2025 UM Annual Review. Updated NMOSD criteria to include t/f through Ultomiris. Background updates
• 2024-04-23: Update to standard reauth verbiage. No changes to clinical intent
• 2024-01-05: 2024 UM Annual Review. Removed criteria related to dosing. Added in T/F criteria based on formulary strategy to reauth sections
• 2023-01-25: 2023 UM Annual Review. No changes.
• 2022-10-13: GPI Reclassification
• 2022-09-07: Added T/F/CI requirement through Ultomiris or Vyvgart for gMG.
• 2022-01-18: 2022 UM Annual Review.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-01-21: 2021 UM Annual Review.
• 2021-01-05: Added FDA-approved dosing to each criteria to prevent overutilization
• 2020-01-10: 2020 Annual Review. No changes to criteria or references.
• 2019-11-07: Updated criteria for the indication of atypical hemolytic uremic syndrome to include a step through Ultomiris. Pending Dec 2019 P&T decision - SL - 11.07.19
• 2019-09-03: Updated guideline with criteria for new indication (Neuromyelitis Optica Spectrum Disorder [NMOSD]) and updated background.

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