Eculizumab (Soliris) and biosimilars coverage
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Defines medical necessity, prior authorization, and dosing criteria for Soliris and its biosimilars (eculizumab-aeeb, eculizumab-aagh) across indications including PNH, aHUS, gMG, and NMOSD for Centene lines of business.
Added newly approved biosimilar Bkemv and updated Soliris concurrent-therapy restrictions to include additional therapies for gMG and PNH.
Added biosimilar Epysqli and updated its FDA-approved indication to include adult patients with gMG who are AChR antibody positive.
Revised continued approval duration from 6 to 12 months for all indications classified as chronic conditions.
Added PiaSky to the list of therapies that should not be prescribed concurrently with Soliris/Bkemv/Epijkstra for PNH.
For gMG, clarified that the required immunosuppressive therapy should be non-steroidal.
Coverage Criteria for Eculizumab (Soliris) and Biosimilars
Initial Therapy: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Covered when ALL of the following are met
Approval duration: 6 months
Initial Therapy: Atypical Hemolytic Uremic Syndrome (aHUS)
Covered when ALL of the following are met
Initial Therapy: Generalized Myasthenia Gravis (gMG)
Covered when ALL of the following are met
Initial Therapy: Neuromyelitis Optica Spectrum Disorder (NMOSD)
Covered when ALL of the following are met
Continued Therapy Criteria (by indication)
Covered when ALL of the following are met for continuation
Dosage and supplemental dosing criteria
Dosing and supplemental dosing conditions
See Sections V and Appendix E for pediatric and weight‑based dosing and for exceptions.
Supplemental dosing may be approved only when documentation of the intervention is provided.
General coverage conditions
Covered when ALL applicable FDA/label and policy-specific requirements are met (per-indication criteria referenced elsewhere in the full policy).
Supplemental dosing may be approved if member is receiving plasmapheresis, plasma exchange, fresh frozen plasma, or IVIg; prior authorization and HCPCS coding apply (see policy).
Coverage is not authorized for STEC-HUS and for non‑FDA approved indications that are not addressed in this policy unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for marketplace, CP.PMN.53 for Medicaid) or other evidence of coverage documents.
Requests for the following diagnoses are specifically excluded from coverage: STEC‑HUS, antiphospholipid syndrome (D68.61), and unspecified nephritic syndrome with other morphologic changes (N0S.8). Use of eculizumab, Bkemv, or Epysqli for these and other non‑FDA indicated conditions is considered investigational or not authorized unless supported by the off‑label use policies or other formal evidence of coverage.
Concurrent prescribing of Soliris, Bkemv, or Epysqli with certain other complement‑ or immune‑modulating therapies is restricted and may result in denial if used outside permitted exceptions. Examples of therapies listed in the policy as not to be prescribed concurrently include Empaveli, Ultomiris, Rystiggo, Vyvgart, Vyvgart Hytrulo, Zilbrysq, Fabhalta, and most recently PiaSky. For aHUS, the policy explicitly states that Soliris/Bkemv/Epquelize (Epysqli) must not be prescribed concurrently with Ultomiris.
Use of Soliris, Bkemv, or Epysqli for indications that are not FDA‑approved and are not addressed by this policy is considered not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety consistent with the applicable off‑label use policies. Such requests should reference the off‑label policy pathway and provide the clinical evidence required by those policies.
Use of Soliris, Bkemv, or Epysqli for listed excluded indications is considered investigational due to lack of conclusive randomized controlled trial evidence. The policy provides example alternative therapies for some excluded diagnoses (e.g., immunosuppression for unspecified nephritic syndrome) and indicates that investigational uses are not authorized absent robust evidence.
Coding or billing requests that do not align with the policy’s specified indications and coding guidance may not guarantee coverage. The policy’s HCPCS entries (for example, J1299, Q5151, Q5152) are provided for informational purposes only; inclusion of a code does not ensure payment and providers must follow current professional coding guidance when submitting claims.
Coding and Billing Guidance
| D68.61 | Antiphospholipid syndrome |
| N0S.8 | Unspecified nephritic syndrome with other morphologic changes |
| D68.61 | Antiphospholipid syndrome |
| N0S.8 | Unspecified nephritic syndrome with other morphologic changes |
| J1299 | Injection, eculizumab, 2 mg |
| Q5151 | Injection, eculizumab-aagh (epysqli) biosimilar, 2 mg |
| Q5152 | Injection, eculizumab-aeeb (bkemv) biosimilar, 2 mg |
| Q5139 | HCPCS code previously added/removed per updates |
| J1300 | HCPCS code removed per updates |
| J3590 | HCPCS code removed per updates |
| C9399 | HCPCS code removed per updates |
Provider Actions, Authorization and Documentation Requirements
Provider action: Documentation required
Prior Authorization Required — Prior authorization requires documentation that the member meets all indication-specific initial approval criteria and that the drug is prescribed by or in consultation with the appropriate specialist (e.g., hematologist, nephrologist, neurologist). Provider must submit documentation (such as office chart notes, lab results, vaccination records, medication history, and other clinical information) supporting that the member has met all approval criteria. Failure to submit required documentation may result in denial or delay of the request.
- Documentation should include relevant specialist consultation notes when required (hematology for PNH, nephrology for aHUS, neurology for gMG and NMOSD).
- Include vaccination documentation for meningococcal vaccine administered ≥2 weeks prior to first dose when possible, or documentation of an appropriate risk discussion and plan if urgent therapy is needed.
- For initial and continuation requests include medication history showing prior therapies tried and response, transfusion history (for PNH), and any prior dosing/administration records.
Provider action: Diagnostic test expectations
Diagnostic test expectations vary by indication and must be included in initial authorization requests. For PNH, flow cytometry demonstrating detectable glycosylphosphatidylinositol (GPI)-deficient hematopoietic clones or ≥10% PNH cells is required. For gMG, document MG-ADL score at baseline and anti-AChR serology if positive; MGFA clinical classification (Class II–IV) should be recorded. For NMOSD, document anti-AQP4 antibody (AQP4-IgG) serostatus using a validated cell-binding assay and baseline EDSS score. For aHUS, include platelet count, evidence of thrombotic microangiopathy (e.g., elevated LDH, hemolysis), serum creatinine and ADAMTS13 to exclude deficiency.
- PNH: flow cytometry report showing GPI-deficient clone percentage (≥10% threshold).
- gMG: baseline MG-ADL total score, MGFA class, and anti-AChR antibody test result.
- NMOSD: anti-AQP4 antibody (cell-based assay) result and baseline EDSS score.
- aHUS: platelet count, LDH, serum creatinine, documentation excluding ADAMTS13 deficiency and STEC-HUS.
Provider action: Clinical response and biomarker documentation
Clinical response and biomarker documentation must be provided for continuation requests and to demonstrate efficacy. Examples of acceptable response measures include stabilization or improvement in condition-specific markers: for PNH — reduced LDH, fewer transfusions, improved hemoglobin and clinical symptoms; for gMG — ≥2-point reduction in MG-ADL score is considered clinically meaningful; for aHUS — normalization of platelet count and LDH, reduced need for plasma therapy or dialysis, improved GFR; for NMOSD — stabilization or reduction in EDSS and relapse frequency. For AQP4 serostatus, document commercial cell-based assay results.
- Include baseline and most recent values for LDH, hemoglobin, transfusion frequency (PNH).
- Provide baseline and follow-up MG-ADL scores and clinical notes documenting functional change (gMG).
- Provide platelet count, LDH, creatinine/GFR trends and dialysis dependence status (aHUS).
- Document relapses, EDSS trend, and AQP4-IgG results (NMOSD).
Provider action: Step therapy requirements / Step therapy sequence
Step therapy and sequencing requirements differ by indication. For gMG, member must have failed a qualifying immunosuppressive therapy (now clarified to one non-steroidal immunosuppressive agent unless contraindicated) and failed a corticosteroid unless contraindicated; MG-related step edits may be subject to state-specific exceptions (e.g., Illinois HB 5395). For NMOSD, member must have failed rituximab at maximally indicated doses (preferred products: Ruxience and Truxima; Truxima and Ruxience specified), with prior authorization generally required for rituximab products. Historically, stepwise redirection requirements (e.g., redirection to Enspryng if rituximab failed) were implemented and later removed; current policy requires failure of rituximab before eculizumab but no mandatory redirection to Enspryng.
- gMG: document trial and failure (or contraindication) of corticosteroid and one non-steroidal immunosuppressive agent unless state law exempts step edits.
- NMOSD: document trial and inadequate response or intolerance to rituximab (preferred biosimilars noted); prior authorization for rituximab products may be required.
- Be aware of state-specific mandates (e.g., IL) that may override step therapy requirements.
Provider action: Continuation and supplemental dosing documentation
Continuation and supplemental dosing documentation — For continuation requests, provide evidence of ongoing clinical benefit per the response measures above. Continuation approvals were revised to longer durations for chronic conditions (continued approval duration updated to 12 months per recent review). Supplemental dosing or additional doses may be approved when the member is receiving plasmapheresis, plasma exchange, fresh frozen plasma infusion, or IVIg; for gMG specifically, supplemental eculizumab dosing is required in the setting of concomitant IVIg. Continuity-of-care allowances have been extended to cover Bkemv and Epysqli for continuation requests.
- Continuation requests must include documentation of clinical benefit (see Clinical response and biomarker documentation).
- If the member is receiving plasmapheresis/plasma exchange/FFP/IVIg, submit timing of procedures and rationale for supplemental dosing per Appendix E.
- Note updated continued approval duration: 12 months for chronic indications (per 3Q 2025 review).
Provider action: Step-therapy history for NMOSD
Step-therapy history for NMOSD — Policy history included a period where, after rituximab failure, members were required to be redirected to Enspryng prior to eculizumab; this redirection requirement was later removed. Current policy requires failure of rituximab (preferred biosimilars noted) prior to consideration of eculizumab, but does not mandate Enspryng as an intermediate step. Providers should document prior rituximab regimen, doses, dates, and rationale for discontinuation or failure.
- Document rituximab product used (e.g., Rituxan, Ruxience, Truxima, Riabni) and dosing regimen (induction: 375 mg weekly x4; maintenance per product regimen).
- If rituximab was not used or was discontinued for intolerance, document reasons and supporting clinical notes.
Background and Clinical Context
Eculizumab and its biosimilars (eculizumab‑aeeb/Bkemv and eculizumab‑aagh/Epysqli) are terminal complement C5 inhibitors used to reduce complement‑mediated hemolysis in paroxysmal nocturnal hemoglobinuria (PNH), to treat complement‑mediated thrombotic microangiopathy in atypical hemolytic uremic syndrome (aHUS), and to manage certain antibody‑mediated neurologic conditions such as AChR‑positive generalized myasthenia gravis (gMG) and AQP4‑antibody positive neuromyelitis optica spectrum disorder (NMOSD). The policy references specific diagnostic and response biomarkers (for example, flow cytometry for GPI‑deficient clones in PNH, platelet count and LDH for aHUS, MG‑ADL for gMG, and AQP4 seropositivity and EDSS for NMOSD) to support initiation and continuation decisions.
Definitions and Abbreviations
Revision History and Material Changes
RT4 3Q 2024 annual review: added biosimilars Bkemv and Epysqli, updated concurrent-therapy restrictions to include Rystiggo, Vyvgart Hytrulo, Zilbrysq (gMG), Fabhalta (PNH), and Ultomiris (NMOSD); updated Epysqli FDA indication to include adult gMG AChR-positive patients; HCPCS code changes applied.
3Q 2025 annual review: updated Bkemv FDA indication to include adult gMG AChR-positive patients; added PiaSky to PNH non-concurrency list; clarified that required immunosuppressive therapy for gMG should be non-steroidal; revised continued approval duration from 6 to 12 months for chronic indications.
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