CurrentCommunity-CarePolicy N/A

Bkemv, Epysqli, Soliris (eculizumab) — Medical Benefit Medication Utilization Policy

Defines clinical coverage, initial and continuation approval criteria, quantity limits, authorization period, and applicable HCPCS codes for eculizumab and its biosimilars under the medical benefit for eligible patients and prescribers.

Policy Summary

PayerCommunity-Care

PolicyEculizumab and biosimilars medical benefit medication utilization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJun 1, 2025

Key ActionPrior authorization is required and will be granted only when diagnosis-specific criteria and prescriber/consultation requirements are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4diagnoses with explicit criteria

≥2 monthsmin age aHUS

≥18 yrsmin age PNH

1 yrauthorization period

Nonequantity limits

Coverage Criteria and Medical Necessity

Initial Approval — Atypical hemolytic uremic syndrome (suspected)

Covered when ALL of the following are met

aHUS initial criteria

Diagnosis: Suspected diagnosis of atypical hemolytic uremic syndrome
Prescriber: Prescribed by, or in consultation with, a hematologist, nephrologist, or oncologist
Age ≥ 2 months
STEC-HUS testing: Documentation of a negative Shiga toxin E. coli related hemolytic uremia syndrome (STEC-HUS) test

Policy Summary

PayerCommunity-Care

PolicyEculizumab and biosimilars medical benefit medication utilization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJun 1, 2025

Key ActionPrior authorization is required and will be granted only when diagnosis-specific criteria and prescriber/consultation requirements are met.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Approval — Generalized myasthenia gravis (gMG)

Covered when ALL of the following are met

gMG initial criteria

Prescriber: Prescribed by, or in consultation with, a neurologist
Diagnosis of generalized myasthenia gravis
Antibody: Positive serologic test for anti-acetylcholine antibodies
Severity: Myasthenia Gravis Foundation of America (MGFA) Class II to IV
Symptom burden: Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score ≥ 6
Prior acetylcholinesterase trial: A trial of an acetylcholinesterase inhibitor ineffective, contraindicated, or not tolerated
Prior immunotherapy: A trial of one of the following was ineffective, not tolerated, or both are contraindicated: 1) Oral corticosteroid; 2) Oral non-steroidal immunosuppressant
Concomitant biologics: Will not be used in combination with other biologic therapies for myasthenia gravis

Initial Approval — Neuromyelitis optica spectrum disorder (NMOSD)

Covered when ALL of the following are met

NMOSD initial criteria

Diagnosis of neuromyelitis optica spectrum disorder
Antibody: Documentation of a positive test for anti-aquaporin-4 antibodies
Prescriber: Prescribed by, or in consultation with, a neurologist or a neuroophthalmologist
Concomitant biologics: Will not be used in combination with another biologic product used for neuromyelitis optica spectrum disorder

Initial Approval — Paroxysmal nocturnal hemoglobinuria (PNH)

Covered when ALL of the following are met

PNH initial criteria

Prescriber: Prescribed by, or in consultation with, a hematologist or immunology specialist
Diagnosis confirmation: Diagnosis of paroxysmal nocturnal hemoglobinuria, confirmed by all of the following: 1) Flow cytometry analysis; 2) Laboratory results (e.g. LDH > 1.5 x ULN, hemoglobin < 10 g/dL); 3) Signs and symptoms of paroxysmal nocturnal hemoglobinuria (e.g., anemia, muscle spasms, dark-colored urine)
Age ≥ 18 years
Concomitant complement inhibitors: Will not use in combination with another complement inhibitor for paroxysmal nocturnal hemoglobinuria that is not FDA approved for use as add-on therapy to eculizumab

Use of eculizumab or its biosimilars in combination with other biologic therapies for the same indication is prohibited. Specifically, for generalized myasthenia gravis (gMG) the policy states the product "will not be used in combination with other biologic therapies for myasthenia gravis", and for neuromyelitis optica spectrum disorder (NMOSD) it states the product "will not be used in combination with another biologic product used for neuromyelitis optica spectrum disorder". For paroxysmal nocturnal hemoglobinuria (PNH), the policy prohibits use in combination with another complement inhibitor that is not FDA approved as add-on therapy to eculizumab. Providers must therefore avoid concurrent prescribing of non‑approved complementary agents or other biologics for these indications when seeking coverage.

Billing Codes and Laboratory Criteria

Applicable HCPCS CodesHCPCS

J1299	Injection, eculizumab, 2 mg
Q5151	Injection, eculizumab-aagh (epysqli), biosimilar, 2 mg
Q5152	Injection, eculizumab-aeeb (bkemv), biosimilar, 2 mg

HCPCS

No codes listed

LDH

Threshold> 1.5 times the upper limit of normal (LDH)

ContextSupportive laboratory finding for diagnosis confirmation of paroxysmal nocturnal hemoglobinuria (PNH)

Documentation requirementReported as part of laboratory results accompanying flow cytometry for PNH confirmation

Hemoglobin

ThresholdHemoglobin < 10 g/dL

ContextSupportive laboratory finding included with LDH and signs/symptoms to confirm paroxysmal nocturnal hemoglobinuria (PNH)

Documentation requirementReported in laboratory results submitted with flow cytometry to confirm PNH diagnosis

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be granted only when diagnosis-specific criteria and prescriber/consultation requirements are met.

Applicable diagnoses include atypical hemolytic uremic syndrome, generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD), and paroxysmal nocturnal hemoglobinuria.

Step Therapy

Step Therapy for gMG

For generalized myasthenia gravis (gMG), a trial of specified therapies is required prior to approval: an acetylcholinesterase inhibitor and either an oral corticosteroid or an oral non‑steroidal immunosuppressant (unless ineffective, not tolerated, or contraindicated).

Document trial(s), reason for discontinuation or intolerance, or clinical rationale if trials are contraindicated.

Documentation Required

Required Documentation

Documentation must include diagnosis-specific test results and specialist involvement: e.g. negative STEC-HUS test for suspected atypical HUS; positive anti-acetylcholine antibody serology, MGFA class and MG‑ADL score for gMG; positive anti‑AQP4 antibody for NMOSD; flow cytometry and supporting labs/symptoms for PNH. Prescriptions should be by or in consultation with the specified specialists.

A weight is required for approval.
Prescriber specialties: hematology, nephrology, oncology, neurology, neuro‑ophthalmology, immunology as indicated by diagnosis.

Denial Risk

Triggers for Potential Denial

Potential denial triggers include missing or incomplete required diagnostic testing, lack of documented specialist prescription or consultation, absent clinical severity measures (e.g., MG‑ADL <6 without documented rationale), failure to document required prior therapy trials for gMG, or concurrent use of prohibited combination biologic/complement inhibitors.

Missing negative STEC‑HUS test for atypical HUS may lead to denial.
For gMG: absent positive serology, MGFA class II–IV, MG‑ADL ≥6, or missing trial documentation may trigger denial.
For NMOSD and PNH: missing antibody or flow cytometry confirmation respectively may trigger denial.
Concurrent use with another biologic for the same indication or non‑FDA approved complement inhibitor combinations for PNH are denial risks.

Background and Clinical Context

Eculizumab and its biosimilars (Bkemv, Epysqli, Soliris) are complement inhibitors approved for severe complement‑mediated disorders including atypical hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), neuromyelitis optica spectrum disorder (NMOSD), and generalized myasthenia gravis (gMG). Clinical coverage under the medical benefit requires diagnosis‑specific confirmation (for example, negative STEC‑HUS testing for suspected aHUS; flow cytometry and supportive labs for PNH; positive anti‑acetylcholine receptor antibodies for gMG; positive anti‑aquaporin‑4 antibodies for NMOSD) and appropriate specialist prescribing or consultation. Prior authorization is required and, when approved, coverage is typically authorized for up to 1 year.

OpenPayer

Bkemv, Epysqli, Soliris (eculizumab) — Medical Benefit Medication Utilization Policy

Coverage Criteria and Medical Necessity

Billing Codes and Laboratory Criteria

Prior Authorization, Documentation, and Provider Requirements

Background and Clinical Context

Definitions and Response Criteria