Eculizumab Products
Indications for Prior Authorization
Bkemv (eculizumab-aeeb)
-
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: Bkemv 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.
Epysqli (eculizumab-aagh)
-
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: Epysqli 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 generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older 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.
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 generalized myasthenia gravis (gMG) in adult and pediatric patients six years of age and older 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
Bkemv, Epysqli, 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
Bkemv, Epysqli, 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)
Bkemv, Epysqli, 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
Bkemv, Epysqli, 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)
Bkemv, Epysqli [off-label], 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
- Patient is 6 years of age or older AND
- Trial and failure, contraindication (e.g., age), or intolerance to one of the following:
- Ultomiris (ravulizumab)
- Vyvgart (efgartigimod)
- One of the following: [2, 3]
- For patients between 6 and 17 years of age, trial and failure, contraindication, or intolerance to one of the following:
- Immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
- Chronic plasmapheresis or plasma exchange (PE)
- Intravenous immunoglobulin (IVIG)
- For patients 18 years of age or older, one of the following:
- 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)
- Prescribed by or in consultation with a neurologist
Bkemv, Epysqli [off-label], 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 (e.g., age), or intolerance to one of the following:
- Ultomiris (ravulizumab)
- Vyvgart (efgartigimod)
Bkemv, Epysqli [off-label], Soliris [off-label]
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
Bkemv, Epysqli [off-label], Soliris [off-label]
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
2025-04-03, 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
- Soliris Prescribing Information. Alexion Pharmaceuticals, Inc. Boston, MA. February 2025.
- 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.
- Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology. 2016;87(4):419-25.
- Bkemv Prescribing Information. Amgen Inc. Thousand Oaks, CA. October 2024.
- Epysqli Prescribing Information. Samsung Bioepis Co., Ltd. Incheon, Republic of Korea. July 2024.
Revision History
- 2025-04-03: Update to Soliris myasthenia gravis guidelines due to new expanded age indication (now indicated for patients 6 years of age or older. Added new biosimilars, Bkemv and Epysqli, to guideline to mirror Soliris criteria
- 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.
HEALTHY LIVING