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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsHMSA Eculizumab Coverage Prior Auth | OpenPayer
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    CurrentHawaii Medical Service Association (HMSA)Policy N/A

    Soliris, Bkemv, and Epysqli (eculizumab products) Coverage and Prior Authorization

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    This policy governs HMSA coverage and prior authorization requirements for Soliris, Bkemv, and Epysqli for eligible members with specified complement-mediated and antibody-positive neurologic conditions across HMO, PPO, and QUEST lines of business.

    Policy Summary
    PayerHawaii Medical Service Association (HMSA)
    PolicySoliris, Bkemv, and Epysqli Coverage and Prior Authorization
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateDec 19, 2025
    Last ReviewOct 1, 2025
    Next Review DateNot specified
    Key ActionSubmit precertification for Soliris, Bkemv, and Epysqli using the HMSA medical specialty drug policy fax form.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    4covered disease indications

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    3
    covered products
    6 monthsinitial authorization
    12 monthsreauthorization
    Prior authorizationcoverage requirement

    Coverage Criteria

    Initial therapy: atypical hemolytic uremic syndrome

    Covered for aHUS when ALL of the following are met.

    aHUS initial therapy

    • Required criteria

      • ADAMTS13 activity level is above 5%.> 5%
      • Shiga toxin status: Shiga toxin is absent.absent
      • Combination therapy: The requested medication will not be used in combination with another complement inhibitor, such as Ultomiris, for the treatment of aHUS.

    Initial therapy: paroxysmal nocturnal hemoglobinuria

    Covered for PNH when ALL of the following are met.

    PNH initial therapy

    • Required criteria

      • GPI-AP deficiency: PNH is confirmed by detecting deficiency of glycosylphosphatidylinositol-anchored proteins, such as at least 5% PNH cells or at least 51% of GPI-AP-deficient polymorphonuclear cells.at least 5% PNH cells or at least 51% deficient polymorphonuclear cells
      • Flow cytometry is used to demonstrate GPI-AP deficiency.
      • Clinical manifestations: The member has and exhibits clinical manifestations such as LDH greater than 1.5 times the upper limit of normal, thrombosis, renal dysfunction, pulmonary hypertension, or dysphagia.LDH > 1.5 times the upper limit of normal or another listed manifestation

    Initial therapy: generalized myasthenia gravis

    Covered for gMG when ALL of the following are met, including at least ONE prior-treatment pathway.

    gMG initial therapy

    • Clinical criteria

      • AChR antibody: Anti-acetylcholine receptor antibody is positive.positive
      • MGFA classification: Myasthenia Gravis Foundation of America clinical classification is II to IV.II-IV
      • MG-ADL score: MG activities of daily living total score is greater than or equal to 5.>= 5

    Initial therapy: neuromyelitis optica spectrum disorder

    Covered for NMOSD when ALL of the following are met, including at least ONE core clinical characteristic.

    NMOSD initial therapy

    • AQP4 antibody: Anti-AQP4 antibody is positive.positive

    • Core clinical characteristic

      • Optic neuritis.
      • Acute myelitis.
      • Area postrema syndrome, including an episode of otherwise unexplained hiccups or nausea and vomiting.

    Continuation and reauthorization

    Reauthorization requires ALL applicable criteria.

    Continuation therapy

    • General continuation criteria

      • Safety and disease control: There is no evidence of unacceptable toxicity or disease progression while on the current regimen.
      • Positive response: The member demonstrates a positive response to therapy.

    • Applicable indication-specific criteria

      • aHUS: For aHUS, the member demonstrates a positive response, such as normalization of LDH levels or platelet counts, and the requested medication will not be used in combination with another complement inhibitor, such as Ultomiris.

    STEC-HUS is excluded from coverage. Soliris, Bkemv, and Epysqli are not indicated for the treatment of Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).

    The requested eculizumab product must not be administered with specified overlapping therapies. For aHUS, concurrent use with another complement inhibitor, such as Ultomiris, is not permitted. For PNH, concurrent use with Empaveli, Fabhalta, Piasky, or Ultomiris is not permitted; concomitant Voydeya is allowed. For gMG, the product must not be used with another complement inhibitor, such as Ultomiris or Zilbrysq, or with a neonatal Fc receptor blocker, such as Vyvgart, Vyvgart Hytrulo, or Rystiggo. For NMOSD, it must not be administered concomitantly with other biologics used to treat NMOSD.

    Clinical Thresholds

    PNH GPI-AP deficiency threshold
    PNH-cell thresholdAt least 5% PNH cells
    GPI-AP-deficient cell thresholdAt least 51% of GPI-AP-deficient polymorphonuclear cells
    Confirmation methodFlow cytometry is used to demonstrate GPI-AP deficiency
    Generalized myasthenia gravis severity threshold
    MG-ADL thresholdMG-ADL total score greater than or equal to 5
    Required antibody statusAnti-acetylcholine receptor antibody positive
    Required MGFA classification

    Authorization and Submission Requirements

    Prior Authorization

    Precertification Required

    Precertification is required for Soliris, Bkemv, and Epysqli. Refer to the HMSA medical specialty drug policy resources for applicable requirements.

    • Applies to Soliris (eculizumab), Bkemv (eculizumab-aeeb), and Epysqli (eculizumab-aagh).
    Prior Authorization

    Six-Month Initial Authorization

    Six-month initial authorization may be granted when all condition-specific medical-necessity criteria are met.

    • aHUS: ADAMTS13 activity level above 5%; absence of Shiga toxin.
    • PNH: Confirmed GPI-AP deficiency by flow cytometry, with clinical manifestations such as LDH greater than 1.5 times the upper limit of normal, thrombosis, renal dysfunction, pulmonary hypertension, or dysphagia.
    • gMG: AChR-antibody positive; MGFA class II–IV; MG-ADL score ≥5; and applicable prior-treatment or treatment-avoidance requirement.
    • NMOSD: AQP4-antibody positive and at least one qualifying core clinical characteristic.

    Clinical Background

    Soliris, Bkemv, and Epysqli are eculizumab products in the complement-inhibitor class. They reduce hemolysis in paroxysmal nocturnal hemoglobinuria (PNH) and inhibit complement-mediated thrombotic microangiopathy in atypical hemolytic uremic syndrome (aHUS). The policy also addresses selected patients with generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) when the applicable disease-specific requirements are met.

    Condition Definitions

    Atypical hemolytic uremic syndrome (aHUS)
    Underlying disorderA disorder caused by complement-mediated thrombotic microangiopathy
    Coverage conditionThe condition must not be caused by Shiga toxin
    Excluded diseaseShiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS) is not an indicated use
    Paroxysmal nocturnal hemoglobinuria (PNH)
    Disease definitionParoxysmal nocturnal hemoglobinuria (PNH) is a disease in which complement inhibition is used to reduce hemolysis
    Diagnostic confirmationPNH is confirmed by detecting deficiency of glycosylphosphatidylinositol-anchored proteins (GPI-APs)

    Initial Authorization

    Initial authorization

    Initial authorization may be issued for 6 months when the member has a covered indication and meets ALL applicable indication-specific criteria.

    Covered indication

    • aHUS: The member meets all initial-therapy criteria for atypical hemolytic uremic syndrome not caused by Shiga toxin.
    • PNH: The member meets all initial-therapy criteria for paroxysmal nocturnal hemoglobinuria, including diagnostic confirmation, clinical manifestations, and the applicable combination-therapy restriction.
    • gMG: The member meets all initial-therapy criteria for generalized myasthenia gravis, including positive anti-AChR antibody, MGFA classification II to IV, MG-ADL score of at least 5, one prior-treatment pathway, and the applicable combination-therapy restriction.

    Reauthorization

    Reauthorization

    Reauthorization may be issued for 12 months when the member was previously authorized by HMSA/CVS and ALL applicable continuation criteria are met.

    • Prior authorization history: The member was previously authorized by HMSA/CVS for the requested therapy.
    • Safety and disease control: There is no evidence of unacceptable toxicity or disease progression while on the current regimen.
    • Positive clinical response: The member demonstrates a positive clinical response to therapy.

    • Applicable indication-specific continuation pathway

    Required Prior Therapy

    StepPrior-treatment requirementDurationResponse or intolerance requirementAlternative
    1
    At least two immunosuppressive therapies, or at least one immunosuppressive therapy plus IVIG
    At least 12 months
    Inadequate response or intolerable adverse event
    A documented clinical reason to avoid immunosuppressive agents and IVIG
    Policy Summary
    PayerHawaii Medical Service Association (HMSA)
    PolicySoliris, Bkemv, and Epysqli Coverage and Prior Authorization
    Policy CodePolicy N/A
    Change TypeNo material clinical or coverage change
    Effective DateDec 19, 2025
    Last ReviewOct 1, 2025
    Next Review DateNot specified
    Key ActionSubmit precertification for Soliris, Bkemv, and Epysqli using the HMSA medical specialty drug policy fax form.
    SourceLink
    On This Page
    Coverage CriteriaClinical ThresholdsAuthorization and Submission RequirementsClinical BackgroundCondition DefinitionsInitial AuthorizationReauthorizationRequired Prior Therapy
  1. Combination therapy: The requested medication will not be used in combination with Empaveli, Fabhalta, Piasky, or Ultomiris for the treatment of PNH; concomitant use with Voydeya is allowed.

  2. Prior-treatment pathway

    • Two immunosuppressive therapies: The member has had an inadequate response or intolerable adverse event to at least two immunosuppressive therapies over at least 12 months.at least 2 therapies over at least 12 months

      Examples include azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, and tacrolimus.

    • Immunosuppressive therapy plus IVIG: The member has had an inadequate response or intolerable adverse event to at least one immunosuppressive therapy and intravenous immunoglobulin (IVIG) over at least 12 months.at least 1 immunosuppressive therapy plus IVIG over at least 12 months
    • Reason to avoid therapy: The member has a documented clinical reason to avoid therapy with immunosuppressive agents and IVIG.
  3. Combination therapy: The requested medication will not be used in combination with another complement inhibitor, such as Ultomiris or Zilbrysq, or a neonatal Fc receptor blocker, such as Vyvgart, Vyvgart Hytrulo, or Rystiggo.
    4. Acute brainstem syndrome.
  4. Diencephalic syndrome: Symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions.
  5. Cerebral syndrome: Symptomatic cerebral syndrome with NMOSD-typical brain lesions.
  6. Combination therapy: The member will not receive the requested medication concomitantly with other biologics for the treatment of NMOSD.
  7. PNH: For PNH, the member demonstrates a positive response, such as improvement in hemoglobin levels or normalization of LDH levels, and the requested medication will not be used in combination with Empaveli, Fabhalta, Piasky, or Ultomiris; concomitant use with Voydeya is allowed.
  8. gMG: For gMG, the member demonstrates a positive response, such as improvement in MG-ADL score, MG Manual Muscle Test, or MG Composite, and the requested medication will not be used in combination with another complement inhibitor, such as Ultomiris or Zilbrysq, or a neonatal Fc receptor blocker, such as Vyvgart, Vyvgart Hytrulo, or Rystiggo.
  9. NMOSD: For NMOSD, the member demonstrates a positive response, such as a reduction in the number of relapses, and will not receive the requested medication concomitantly with other biologics for the treatment of NMOSD.
    10. MGFA clinical classification II to IV
    aHUS ADAMTS13 threshold
    ADAMTS13 activity thresholdAbove 5%
    Shiga toxin statusShiga toxin absent
    Applicable conditionAtypical hemolytic uremic syndrome not caused by Shiga toxin
    PNH clinical manifestation threshold
    LDH thresholdGreater than 1.5 times the upper limit of normal (LDH > 1.5 ULN)
    Other clinical manifestationsThrombosis, renal dysfunction, pulmonary hypertension, or dysphagia
    Applicable conditionConfirmed paroxysmal nocturnal hemoglobinuria with clinical manifestations
    Prior Authorization

    Twelve-Month Reauthorization

    Twelve-month reauthorization may be granted to members previously authorized by HMSA/CVS when continuation requirements are met.

    • There must be no unacceptable toxicity or disease progression on the current regimen.
    • The member must demonstrate a positive clinical response, such as normalized LDH or platelet counts for aHUS; improved hemoglobin or LDH for PNH; improved MG-ADL, MG Manual Muscle Test, or MG Composite scores for gMG; or fewer relapses for NMOSD.
    Step Therapy

    gMG Prior-Treatment Requirement

    For gMG, document inadequate response or an intolerable adverse event to required prior therapies over the specified period, unless there is a documented clinical reason to avoid immunosuppressive agents and IVIG.

    • At least two immunosuppressive therapies over at least 12 months; or
    • At least one immunosuppressive therapy plus IVIG over at least 12 months; or
    • A documented clinical reason to avoid immunosuppressive agents and IVIG.
    Documentation Required

    Initial Request Documentation

    Include condition-specific diagnostic and clinical documentation with the initial request.

    • aHUS: ADAMTS13 level.
    • PNH: Flow cytometry demonstrating GPI-AP deficiency, including the documented PNH-cell findings.
    • gMG: Positive AChR-antibody test, MGFA clinical classification, MG-ADL score, and previous medications tried with responses or clinical reasons therapy was avoided.
    • NMOSD: Immunoassay confirming the presence of AQP4 antibody.
    Documentation Required

    Continuation Documentation

    For continuation requests, submit chart notes or medical-record documentation supporting a positive clinical response to therapy.

    • Documentation should support the condition-specific response used for reauthorization, such as laboratory improvement, improved disease scores, or reduced NMOSD relapses.
    Documentation Required

    Precertification Submission

    Submit the precertification request using the HMSA medical specialty drug policy fax form.

    • Refer to the HMSA medical specialty drug policy website for the applicable fax form.
    Denial Risk

    STEC-HUS Excluded

    Soliris, Bkemv, and Epysqli are not indicated for, and coverage is excluded for, Shiga toxin E. coli–related hemolytic uremic syndrome (STEC-HUS).

    • Do not request these medications for STEC-HUS.
    Denial Risk

    Prohibited Complement-Inhibitor Combinations

    Coverage may be denied when the requested medication is used with another prohibited complement inhibitor for the same condition.

    • aHUS: Do not combine with Ultomiris.
    • PNH: Do not combine with Empaveli, Fabhalta, Piasky, or Ultomiris; concomitant use with Voydeya is allowed.
    • gMG: Do not combine with another complement inhibitor such as Ultomiris or Zilbrysq.
    Denial Risk

    Prohibited gMG Combination Therapy

    For gMG, do not use the requested medication in combination with another complement inhibitor or a neonatal Fc receptor blocker.

    • Prohibited neonatal Fc receptor blockers include Vyvgart, Vyvgart Hytrulo, and Rystiggo.
    Denial Risk

    Prohibited NMOSD Biologic Combination

    For NMOSD, do not administer the requested medication concomitantly with other biologics used to treat NMOSD.

    • This restriction applies to both initial authorization and reauthorization.

    Unsupported block type: prior_auth of callout

    Clinical manifestation example
    LDH greater than 1.5 times the upper limit of normal, thrombosis, renal dysfunction, pulmonary hypertension, or dysphagia
    Generalized myasthenia gravis (gMG)
    Antibody requirementAnti-acetylcholine receptor antibody positive
    Disease classification and severityMGFA clinical classification II to IV and MG-ADL total score greater than or equal to 5
    Prior-treatment requirementInadequate response or intolerable adverse event to at least two immunosuppressive therapies over at least 12 months, or to at least one immunosuppressive therapy plus IVIG over at least 12 months; a documented clinical reason to avoid immunosuppressive agents and IVIG may substitute
    Neuromyelitis optica spectrum disorder (NMOSD)
    Antibody requirementAnti-aquaporin-4 (AQP4) antibody positive
    Core clinical requirementAt least one specified core clinical characteristic of NMOSD
    Core clinical characteristicsOptic neuritis; acute myelitis; area postrema syndrome; acute brainstem syndrome; symptomatic narcolepsy or acute diencephalic clinical syndrome with NMOSD-typical diencephalic MRI lesions; or symptomatic cerebral syndrome with NMOSD-typical brain lesions
    NMOSD: The member meets all initial-therapy criteria for AQP4-antibody-positive neuromyelitis optica spectrum disorder, including at least one core clinical characteristic and the applicable biologic-therapy restriction.
    aHUS: For aHUS, response may include normalization of LDH levels or platelet counts, and the requested medication is not used with another complement inhibitor such as Ultomiris.
  10. PNH: For PNH, response may include improvement in hemoglobin levels or normalization of LDH levels, and the requested medication is not used with Empaveli, Fabhalta, Piasky, or Ultomiris; concomitant use with Voydeya is allowed.
  11. gMG: For gMG, response may include improvement in MG-ADL score, MG Manual Muscle Test, or MG Composite, and the requested medication is not used with another complement inhibitor or neonatal Fc receptor blocker.
  12. NMOSD: For NMOSD, response may include a reduction in relapses, and the requested medication is not administered concomitantly with other NMOSD biologics.