CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Eculizumab Products (Soliris, Epysqli, Bkemv) — Coverage Criteria

Defines accepted indications, exclusions, coding, and prior authorization expectations for eculizumab and its biosimilars for members served by the payer; applies to providers requesting coverage/authorization for these products.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEculizumab Products (Soliris, Epysqli, Bkemv) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded biosimilarstemplate update

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, meningococcal vaccination status, and required lab evidence for aHUS or PNH per criteria.

SourceLink

POLICY UPDATE CHANGES

Added new biosimilar 'Bkemv (eculizumab-aeeb)' to policy.

Added new biosimilar 'Epysqli (eculizumab-aagh)' to policy.

Converted to new Evolent guideline template and replaced prior UM ONC_1382 guideline.

3product names listed

2FDA-indicated diagnoses covered

3HCPCS/J-codes listed

4meningococcal serogroups referenced

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PNH (Initial Therapy)

Covered when ALL of the following are met:

PNH initial coverage: Member has hemolytic paroxysmal nocturnal hemoglobinuria and eculizumab/eculizumab biosimilar is being used to reduce hemolysis.

Document diagnosis of hemolytic PNH and intent to use eculizumab to reduce intravascular hemolysis.

aHUS (Initial Therapy)

Covered when ALL of the following are met:

aHUS initial coverage: Member has confirmed diagnosis of atypical hemolytic uremic syndrome with evidence of hemolysis (LDH above normal or haptoglobin below normal or schistocytes on peripheral smear) AND impaired renal function (serum creatinine above normal).

Provide laboratory or smear evidence of hemolysis and impaired renal function with the request.

Continuation Therapy

Continuation therapy allowable when ALL are met:

Continuation criteria: No disease progression on the medication; the medication was used within the last year without a lapse greater than 30 days of an active authorization; no additional medications are being added to the continuation request.

Continuation requests for a not-approvable medication are exempt if all conditions are satisfied.

Eculizumab and its biosimilars are not indicated for treatment of Shiga toxin-producing E. coli–associated hemolytic uremic syndrome (STEC-HUS) or thrombotic thrombocytopenia purpura (TTP). TTP is defined here as ADAMTS-13 activity <5%. In addition, use of eculizumab/eculizumab biosimilars for investigational or off‑label indications that lack sufficient supporting evidence or are not generally accepted by the medical community is excluded from coverage. Sufficient evidence is interpreted as support from CMS‑recognized compendia or acceptable peer‑reviewed literature, with consideration of whether the patient population, regimen, and clinically meaningful outcomes are adequately represented.

Disease progression while on eculizumab or an eculizumab biosimilar is considered non‑covered for continuation when there is a lack of hemoglobin response and the member remains dependent on blood transfusions. Continuation requests should demonstrate clinical benefit; persistent transfusion dependence or failure to achieve an expected rise in hemoglobin indicates treatment failure and supports a determination of not medically necessary for ongoing therapy.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization / Continuation Criteria

Prior authorization is required for eculizumab and eculizumab biosimilars. For continuation (renewal) requests, ensure there has been no disease progression on the requested medication and that the prior authorization remained active within the last year without a gap greater than 30 days. Continuation requests that add additional medications are not exempt.

Continuation allowed if no disease progression and prior authorization active within past year with <=30 day lapse
Prior authorization required for new starts and for continuation requests that do not meet exemption criteria

Denial Risk

Use After Disease Progression

Eculizumab/eculizumab biosimilar use is not appropriate if the member experienced disease progression while on eculizumab or another anti‑complement therapy (for example, ravulizumab/Ultomiris) defined by lack of hemoglobin response and continued need for transfusions. Use after documented progression on the same regimen or other anti‑complement agents requires strong justification and is typically excluded.

Denial risk if prior progression on eculizumab or other complement inhibitors (e.g., ravulizumab)
Progression defined by persistent hemolysis, no rise in hemoglobin, and continued transfusion dependence

Documentation Required

aHUS Diagnostic Evidence

For a diagnosis of atypical hemolytic uremic syndrome (aHUS), document a confirmed diagnosis and laboratory evidence of active hemolysis and renal impairment. Required supporting data include LDH above normal, low haptoglobin, schistocytes on peripheral smear, and serum creatinine above the laboratory normal range.

Documented confirmed diagnosis of aHUS
Laboratory evidence of hemolysis: elevated LDH, decreased haptoglobin, and/or schistocytes on peripheral smear
Evidence of renal impairment: serum creatinine above normal

Documentation Required

PNH Diagnostic Evidence and Treatment Intent

For paroxysmal nocturnal hemoglobinuria (PNH), document a diagnosis of hemolytic PNH and that eculizumab/eculizumab biosimilar is being used to reduce hemolysis. Include relevant baseline hemoglobin, markers of hemolysis, and clinical intent to reduce transfusion dependence or hemolytic complications.

Documented diagnosis of hemolytic PNH
Statement of intent: therapy is to reduce hemolysis and related complications
Baseline hemoglobin and hemolysis markers to support clinical need

Step Therapy

Step / Sequence Therapy Restriction

Eculizumab/eculizumab biosimilar should be used in sequence only when prior anti‑complement therapy requirements are met. Use after other anti‑complement therapy (e.g., switching from ravulizumab/Ultomiris) is restricted — prior treatment course, reason for switch, and lack of alternative effective options must be documented. Requests to use eculizumab after failure or progression on another complement inhibitor are subject to denial.

Document prior anti‑complement therapies, dates, and reason for change (e.g., intolerance vs progression)
Requests following progression on another complement inhibitor generally will be denied without compelling evidence

Key Definitions

aHUS (definition)

DefinitionAtypical hemolytic uremic syndrome (aHUS): complement-mediated microangiopathy with evidence of hemolysis (LDH above normal or haptoglobin below normal or schistocytes on peripheral smear) AND impaired renal function (serum creatinine above normal)

Required diagnostic evidenceLaboratory evidence of hemolysis (elevated LDH, low haptoglobin, or schistocytes)

Required renal evidenceImpaired renal function demonstrated by serum creatinine above normal

PNH (definition)

DefinitionParoxysmal nocturnal hemoglobinuria (PNH): hemolytic PNH where eculizumab/eculizumab biosimilar is used to reduce intravascular hemolysis

Treatment intentEculizumab prescribed to reduce hemolysis in members with hemolytic PNH

Documentation neededClinical record must document diagnosis of hemolytic PNH and intent to reduce hemolysis

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

OpenPayer

Eculizumab Products (Soliris, Epysqli, Bkemv) — Coverage Criteria

Coverage Criteria for Eculizumab Products

Provider Requirements and Prior Authorization

Billing Codes and Dosing Limits

Key Definitions

Background