CurrentCignaPolicy N/A

Eculizumab (Soliris, Bkemv, Epysqli) prior authorization

Prior authorization form and clinical coverage requirements for eculizumab products for Cigna members, covering multiple indications (aHUS, gMG, PNH, NMOSD and others) and settings where medication is obtained/administered.

Policy Summary

PayerCigna

PolicyEculizumab (Soliris, Bkemv, Epysqli) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a prior authorization using the form with J-code and ICD-10 and include supporting clinical documentation (labs, specialist notes).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time for prescription drug coverage requests

4explicit major diagnoses on form (aHUS, gMG, PNH, NMOSD)

multiplelisted eculizumab products

faxmethod for submission

Coverage Criteria

Indication-specific coverage criteria

Coverage evaluation requires condition-specific documentation and specialist involvement; many items require a 'Yes' attestation or attached evidence. Requests lacking required documentation may be denied.

aHUS initial/continuation: Non–Shiga-toxin (STEC) hemolytic uremic syndrome: prescriber attests that the patient does NOT have Shiga toxin E. coli–related HUS and that the medication is prescribed by or in consultation with a nephrologist.

Support: clinical questions on aHUS require Shiga-toxin status and nephrologist involvement.

gMG initial: For patients not currently receiving eculizumab: documentation of anti-acetylcholine receptor antibody–positive generalized myasthenia gravis, age ≥18 (when applicable) with MGFA class II–IV and MG-ADL score ≥6 (if age ≥18), prior use of pyridostigmine (or documented intolerance/contraindication), and trial of two different immunosuppressant therapies for ≥1 year (or documented intolerance/contraindication). Medication must be prescribed by or in consultation with a neurologist.

Support: MG section requires antibody confirmation, MGFA/MG-ADL, prior pyridostigmine and two immunosuppressants; neurologist involvement.

Policy Summary

PayerCigna

PolicyEculizumab (Soliris, Bkemv, Epysqli) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a prior authorization using the form with J-code and ICD-10 and include supporting clinical documentation (labs, specialist notes).

SourceLink

On This Page

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gMG continuation: For patients currently receiving eculizumab: prescriber attests the patient is continuing to derive clinical benefit (examples: reduced exacerbations, improved speech/swallowing/mobility/respiratory function).

Support: continuation question asks prescriber attestation of ongoing benefit.

NMOSD initial: For initial therapy: documentation that the patient has anti–aquaporin-4 antibody–positive NMOSD confirmed by a blood serum test must be provided. Medication must be prescribed by or in consultation with a neurologist.

Support: NMOSD section requires blood serum anti‑AQP4 confirmation and neurologist involvement.

NMOSD continuation: For patients currently receiving eculizumab: prescriber attests diagnosis was confirmed and that the patient derives clinical benefit (examples: reduced relapse rate or symptom improvement).

Support: continuation asks for confirmation of diagnosis and prescriber attestation of benefit.

PNH initial: For patients not currently receiving eculizumab: documentation that PNH diagnosis was confirmed by peripheral blood flow cytometry showing absence or deficiency of GPI‑anchored proteins on at least two cell lineages. Medication must be prescribed by or in consultation with a hematologist.

Support: PNH section requires flow cytometry confirmation and hematologist involvement.

PNH continuation: For patients currently receiving eculizumab: prescriber attests the patient is deriving benefit (examples: stabilization of hemoglobin, decreased transfusion requirements or transfusion independence, reductions in hemolysis, improvement in FACIT‑Fatigue score).

Support: continuation question requests prescriber attestation of clinical benefit.

The form requires disclosure of concurrent therapy and places conditional restrictions on combination use. Providers must indicate whether the member will receive the requested eculizumab product with Empaveli (pegcetacoplan) for > 4 weeks, and must disclose concomitant use with other complement inhibitors (examples listed on the form include Fabhalta, PiaSky, Ultomiris) as well as certain biologic agents (examples include rituximab products, Neonatal Fc receptor blockers, Zilbrysq, Enspryng, Uplizna).

The form does not include explicit “not medically necessary” language; instead it relies on required documentation fields and attestations. Requests that do not complete the concurrent‑therapy questions, fail to identify the prescribing specialist, or omit other required entries on the form risk denial or delay because the reviewer cannot confirm that clinical criteria or safe co‑administration requirements are met.

Billing and Coding

Required billing identifiersmixed

J-code	J-Code (requested medication billing code) — blank field on form
ICD10	ICD-10 diagnosis code — blank field on form

Provider Actions and Submission

Prior Authorization

Prior Authorization Required

Prior authorization is required for this medication. Include the J-code and applicable ICD-10 diagnosis code(s) on the request. Submit prior authorization requests and all supporting documentation via fax or online through CoverMyMeds or SureScripts in your EHR. Our standard response time for prescription drug coverage requests is 5 business days; for urgent requests call to expedite.

Include J-code and ICD-10 on submission
Submit via fax or online: www.covermymeds.com or SureScripts in EHR
Standard response time: 5 business days; call for urgent reviews

Denial Risk

Documentation-Dependent Denials

Requests that do not include required supporting clinical documentation risk denial. Common documentation-dependent denial reasons include missing antibody test results (e.g., anti-acetylcholine receptor for MG, anti-aquaporin-4 for NMOSD), missing peripheral blood flow cytometry for PNH, absence of documentation of prior therapies or intolerance, and lack of treating specialist consultation notes when required.

Missing antibody test results (e.g., anti-AChR, anti-AQP4)
Missing peripheral blood flow cytometry for PNH
No documentation of prior therapy trials or intolerance
No neurologist or hematologist consultation notes when required

Documentation Required

Required Clinical Documentation

Attach all relevant medical records and test results to the prior authorization request. Required clinical documentation may include laboratory reports (antibody testing, relevant serologies), peripheral blood flow cytometry results, prescriber chart notes, MG-ADL scores or MG Foundation classification when applicable, and evidence of clinical benefit if continuing therapy.

Anti-acetylcholine receptor antibody results (for MG) when applicable
Anti-aquaporin-4 antibody serum test results (for NMOSD) when applicable
Peripheral blood flow cytometry showing GPI-anchored protein deficiency on ≥2 cell lineages (for PNH)
Prescriber chart notes, specialist consultation notes (neurology or hematology)
MG-ADL score and Myasthenia Gravis Foundation of America classification, when relevant
Documentation of clinical benefit for continuation requests

Step Therapy

MG Step Requirements

For myasthenia gravis (MG) requests, documentation must show specialist involvement and prior treatment attempts. If the patient is not currently receiving the medication, provide evidence of confirmed anti-acetylcholine receptor antibody–positive generalized MG and severity/function measures. Demonstrate prior use of pyridostigmine (or documented intolerance/contraindication) and trial of two different immunosuppressant therapies for ≥1 year each, or documentation of inadequate efficacy, contraindication, or significant intolerance to those therapies.

Prescribed by or in consultation with a neurologist
If not currently receiving: confirmed anti-AChR antibody–positive generalized MG (attach test results)
If 18+: MGFA class II–IV and MG-ADL ≥ 6 when initiating therapy (as applicable)
Prior pyridostigmine use OR documented intolerance/contraindication
Prior use of two different immunosuppressants for ≥1 year each OR documented inadequate efficacy/contraindication/intolerance

Definitions / Specialty Pharmacy

Specialty pharmacy

Nationally preferred specialty pharmacyAccredo is Cigna's nationally preferred specialty pharmacy; medication orders can be placed through Accredo (contact details provided).

Online submission optionSave time — submit online at www.covermymeds.com/main/prior-authorization-forms/cigna/ or via SureScripts in your EHR.

Standard response timeOur standard response time for prescription drug coverage requests is 5 business days; call to expedite urgent requests.

Background

Eculizumab is a monoclonal complement C5 inhibitor used for several serious immune-mediated conditions. The prior authorization form lists eculizumab products (brand names on the form include Soliris, Bkemv, Epysqli) and requests condition‑specific diagnostic confirmation and specialist involvement to support coverage decisions for indications such as atypical hemolytic uremic syndrome, generalized myasthenia gravis, paroxysmal nocturnal hemoglobinuria, and anti‑AQP4 antibody–positive neuromyelitis optica spectrum disorder.