CurrentViva HealthPolicy IC-P0114

Eculizumab (Soliris, Bkemv, Epysqli) intravenous prior authorization and coverage

This policy defines prior authorization clinical criteria, dosing limits, renewal requirements, and billing codes for intravenous eculizumab (Soliris) and its biosimilars for indications including PNH, aHUS, gMG, NMOSD and other FDA-labeled uses. It applies to Viva Health medical benefit drug review.

Policy Summary

PayerViva Health

PolicyEculizumab (Soliris, Bkemv, Epysqli) intravenous prior authorization and coverage

Policy CodePolicy IC-P0114

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization with documentation confirming diagnosis, required labs/serologies, prior therapy trials or intolerances, and specialist involvement.

SourceLink

6Initial authorization length

12Renewal authorization interval (months)

J1299,Q5151,Q5152HCPCS codes listed for billing

PNH,aHUS,gMG,NMOSDPrimary covered diagnoses

Initial and Renewal Medical Necessity Criteria

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Indication (ONE of the following)

Generalized Myasthenia Gravis (gMG)
- Diagnosis of generalized Myasthenia Gravis (gMG)
- Positive serological test for anti-AChR antibodies
  medical records required
- MGFA clinical classification class II-IVb
- MG-Activities of Daily Living (MG-ADL) total score >= 6>= 6
Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Diagnosis of PNH
- Diagnosis confirmed by flow cytometry with at least 2 independent reagents on at least 2 cell lineages demonstrating deficiency of GPI-linked proteins
  lab tests required
Atypical Hemolytic Uremic Syndrome (aHUS)
- Diagnosis of aHUS
- Diagnosis confirmed by ONE of: pathogenic genetic mutation (e.g., CFH, CD46, CFI, C3, CFB, THBD, CFHR1/3/5), antibodies to complement factors, or demonstration of a differential diagnosis of complement-mediated HUS (including exclusion of STEC-HUS, pneumococcal-associated HUS, TTP with ADAMTS13 <10%, or defective cobalamin metabolism)
  medical records required
- Patient negative for Shiga toxin-producing E. coli (STEC)
Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Diagnosis of NMOSD
- Anti-aquaporin-4 (AQP4) antibody positive
  lab test required
- Diagnosis confirmed by at least ONE of: optic neuritis; acute myelitis; area postrema syndrome; acute brainstem syndrome; symptomatic narcolepsy/acute diencephalic syndrome with NMOSD-typical MRI lesions; symptomatic cerebral syndrome with NMOSD-typical brain lesions
- At least ONE discrete clinical attack of CNS symptoms
- Alternative diagnoses (e.g., MS, ischemic optic neuropathy) have been ruled out
Other FDA-labeled indication
- Patient has another FDA-labeled indication for the requested agent and route of administration
- ANY of the following
  - Patient's age is within FDA labeling for the requested indication
  - There is support for the use of the requested agent for the patient's age for the requested indication

ALL of the following

Prescriber is a specialist in the area of the patient's diagnosis or has consulted with such a specialist (e.g., neurologist, hematologist)
Patient will NOT be using the requested agent in combination with Ultomiris (ravulizumab-cwvz), Soliris (eculizumab), Bkemv (eculizumab-aeeb), or Epysqli (eculizumab-aagh)
Avoid combination therapy with other complement inhibitors/biosimilars as listed
Patient does NOT have any FDA labeled contraindications to the requested agent
Requested quantity (dose) is within FDA labeled dosing for the requested indication

Renewal Criteria

Target agent(s) will be approved on renewal when ALL of the following are met:

ALL of the following

Patient was previously approved for the requested agent through the plan's Medical Drug Review process
ANY of the following
- PNH renewal
  - Diagnosis of PNH
  - Improvements or stabilization with the requested agent (examples: decreased requirement for RBC transfusions, stabilization/improvement of hemoglobin, reduction of LDH)
    medical records required
  - Patient will NOT be using the requested agent in combination with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab-akkz)
- aHUS renewal
  - Diagnosis of aHUS
  - Improvements or stabilization with the requested agent (examples: improved platelet count, reduction of LDH, stabilization/improvement of renal function)
    medical records required
- gMG renewal
  - Diagnosis of generalized myasthenia gravis (gMG)
  - Patient has had clinical benefit with the requested agent
    medical records required
  - Patient will NOT be using the requested agent in combination with Rystiggo, Vyvgart, Vyvgart Hytrulo, Zilbrysq, or Imaavy
- NMOSD renewal
  - Diagnosis of NMOSD
  - Patient has had stabilization or improvement with the requested agent (examples: decreased relapses, improvement or stabilization of vision or paralysis)
    medical records required
  - Patient will NOT be using the requested agent in combination with Enspryng (satralizumab-mwge), Rituximab, or Uplizna (inebilizumab-cdon)
- Other indication renewal
  - Diagnosis other than PNH, aHUS, gMG, or NMOSD
  - Patient has had improvements or stabilization with the requested agent (e.g., improvement or stabilization of symptoms)
    medical records required
Prescriber is a specialist in the area of the patient's diagnosis or has consulted with such a specialist
Patient will NOT be using the requested agent in combination with Ultomiris, Soliris, Bkemv, or Epysqli
Patient does NOT have any FDA labeled contraindications to the requested agent
Requested quantity (dose) is within FDA labeled dosing for the requested indication

Billing and Diagnosis Codes

HCPCS (billing)HCPCSCovered

J1299	Injection, eculizumab, 2 mg; 1 billable unit = 2 mg (Soliris ONLY)
Q5151	Injection, eculizumab-aagh (Epysqli), biosimilar, 2 mg; 1 billable unit = 2 mg
Q5152	Injection, eculizumab-aeeb (Bkemv), biosimilar, 2 mg; 1 billable unit = 2 mg

Covered ICD-10 diagnosis codesICD-10Covered

D59.32	Hereditary hemolytic-uremic syndrome
D59.39	Other hemolytic-uremic syndrome
D59.5	Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli]
G36.0	Neuromyelitis optica [Devic]
G70.00	Myasthenia gravis without (acute) exacerbation
G70.01	Myasthenia gravis with (acute) exacerbation

NDCs (examples listed)NDC

25682-0001-xx	Soliris 300 mg/30 mL single-dose vial for injection
55513-0180-xx	Bkemv 300 mg/30 mL single dose vial for injection
71202-0010-xx	Epysqli 300 mg/30 mL single dose vial for injection

Prior Authorization, Documentation, Renewal, and Restrictions

Prior Authorization

Prior authorization required with initial documentation

Prior authorization is required for initial eculizumab (Soliris/Bkemv/Epysqli) requests. Initial approvals will be provided for 6 months. Submit documentation supporting the diagnosis, required labs/serologies, prior therapy trials or documented intolerances, and evidence of specialist involvement. Billing HCPCS codes: J1299, Q5151, Q5152.

Initial authorization length: 6 months
Required documentation: diagnosis confirmation, labs/serologies, prior therapy trials/intolerances, specialist note
Bill using HCPCS: J1299, Q5151, Q5152

Documentation Required

Diagnostic confirmation required

Provide supporting laboratory reports or medical records to confirm the diagnosis specific to the indication: anti‑AChR antibody for gMG; flow cytometry demonstrating GPI‑linked protein deficiency on at least 2 cell lineages for PNH; genetic testing, complement factor antibodies, or documentation excluding alternative causes (e.g., negative STEC testing, ADAMTS13, pneumococcal evaluation) for aHUS; and AQP4 (anti‑aquaporin‑4) antibody positivity plus documentation of at least one discrete clinical attack and exclusion of alternative diagnoses for NMOSD.

gMG: positive anti‑AChR serology (medical records required) and MGFA/MG‑ADL documentation
PNH: flow cytometry with ≥2 independent reagents on ≥2 cell lineages showing GPI‑linked protein deficiency (lab tests required)
aHUS: pathogenic genetic mutation OR antibodies to complement factors OR demonstrated differential diagnosis excluding STEC‑HUS, pneumococcal‑associated HUS, TTP (ADAMTS13 <10%), or defective cobalamin metabolism; patient negative for STEC
NMOSD: anti‑AQP4 antibody positive, documentation of ≥1 discrete clinical CNS attack, and exclusion of alternative diagnoses

Documentation Required

Demonstration of clinical benefit for renewal

For renewals, submit medical records showing improvement or stabilization attributable to the agent specific to the indication: examples include decreased RBC transfusion needs, stabilization or improvement in hemoglobin, and reduction in LDH for PNH; improved platelet count, reduced LDH, and stabilized/improved renal function for aHUS; and clinical benefit or reduced relapses/stabilization (e.g., vision or paralysis) for gMG and NMOSD.

PNH renewal evidence: decreased RBC transfusions, improved/stable hemoglobin, reduced LDH
aHUS renewal evidence: improved platelet count, reduced LDH, stabilization/improvement of renal function
gMG/NMOSD renewal evidence: clinical benefit or reduced relapses; stabilization or improvement in neurologic function (e.g., vision, paralysis)

Denial Risk

Combination therapy contraindications

Requests will be denied if the patient will be treated concurrently with specified conflicting agents; concurrent use with listed complement‑targeted therapies or other specified immunotherapies is prohibited and will result in denial per the indication‑specific lists.

gMG: concurrent use with Rystiggo (rozanolixizumab‑noli), Vyvgart (efgartigimod), Vyvgart Hytrulo, Zilbrysq (zilucoplan), or Imaavy (nipocalimab) is not allowed
PNH: concurrent use with Empaveli (pegcetacoplan), Fabhalta (iptacopan), or Piasky (crovalimab) is not allowed
NMOSD: concurrent use with Enspryng (satralizumab), Rituximab, or Uplizna (inebilizumab) is not allowed
Across indications/renewal: concurrent use with Ultomiris (ravulizumab), Soliris/Bkemv/Epysqli (other eculizumab products) is not allowed

Step Therapy

Prior therapy requirement for gMG

For generalized myasthenia gravis (gMG), document prior therapy trials: the patient must have tried and had an inadequate response to at least one conventional agent (corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, or cyclophosphamide), or document intolerance/hypersensitivity or FDA‑labeled contraindication to conventional agents, or document requirement for chronic IVIG or chronic plasmapheresis/plasma exchange prior to approval.

Required trial of ≥1 conventional agent for gMG (listed examples)
Or documented intolerance/hypersensitivity to one conventional agent
Or documented FDA contraindication to conventional agents
Or history of chronic IVIG or chronic plasmapheresis/plasma exchange

Clinical and Administrative Context

Eculizumab (Soliris and the biosimilars Bkemv and Epysqli) is a terminal complement inhibitor indicated for complement‑mediated disorders including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), AQP4‑positive neuromyelitis optica spectrum disorder (NMOSD), and generalized myasthenia gravis (gMG) in eligible patients (intravenous formulations).

This prior authorization policy aligns coverage with confirmation of the treated diagnosis and required diagnostic testing: for gMG a positive anti‑AChR serology plus MGFA class II–IVb and an MG‑ADL score ≥ 6 are required; for PNH flow cytometry demonstrating GPI‑linked protein deficiency on at least two cell lineages with at least two independent reagents is required; for aHUS documentation of a pathogenic complement‑related genetic mutation, complement autoantibodies, or a demonstrated differential diagnosis excluding STEC‑HUS, pneumococcal‑associated HUS, TTP (ADAMTS13 <10%), or defective cobalamin metabolism is required; for NMOSD anti‑AQP4 antibody positivity plus clinical attack documentation and exclusion of alternative diagnoses is required.

The policy also requires documentation of prior treatment attempts, intolerances, or contraindications where applicable (for example, trial or intolerance of conventional immunosuppressive agents or requirement for chronic IVIG/plasmapheresis in gMG) and that the prescriber be a relevant specialist or have consulted one. Prior authorization is used to ensure appropriate use, verify dosing within FDA‑labeled regimens, and to document clinical benefit on renewal (e.g., improvements or stabilization in hemoglobin/LDH/transfusion needs for PNH, platelet/renal function/LDH for aHUS, or reduction in relapses/clinical benefit for NMOSD and gMG).

To prevent overlapping complement‑targeted therapy, requests will be denied when eculizumab is to be used concurrently with specified conflicting agents or other complement inhibitors/biosimilars (examples include Ultomiris/ravulizumab, Empaveli/pegcetacoplan, Fabhalta/iptacopan, Piasky/crovalimab, and the listed eculizumab products and biosimilars), consistent with the policy's combination therapy prohibitions.

OpenPayer

Eculizumab (Soliris, Bkemv, Epysqli) intravenous prior authorization and coverage

Initial and Renewal Medical Necessity Criteria

Billing and Diagnosis Codes

Prior Authorization, Documentation, Renewal, and Restrictions

Clinical and Administrative Context

Key Terms

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