CurrentAgency for Health Care AdministrationPolicy N/A

Bkemv, Epysqli, and Soliris Prior Authorization Criteria

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This pharmacy policy governs prior authorization and continuation criteria for Bkemv, Epysqli, and Soliris used for paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis, and, for Soliris only, neuromyelitis optica spectrum disorder. It applies to providers requesting coverage through the Agency for Health Care Administration.

Policy Summary

PayerAgency for Health Care Administration

PolicyBkemv, Epysqli, and Soliris Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeRevision

Effective DateJuly 1, 2026

Next Review DateN/A

Key ActionSubmit documentation of an eligible diagnosis, the required specialist prescriber, and meningococcal vaccination for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearMaximum authorization length

3Covered eculizumab products

4Clinical indication pathways

2 weeksVaccination interval before first Soliris dose

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CurrentAgency for Health Care AdministrationPolicy N/A

Bkemv, Epysqli, and Soliris Prior Authorization Criteria

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Sign up for all Agency for Health Care Administration policy alerts

Know when Agency for Health Care Administration releases new policies or updates existing guidance.

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Policy Summary

PayerAgency for Health Care Administration

PolicyBkemv, Epysqli, and Soliris Prior Authorization Criteria

Policy CodePolicy N/A

Change TypeRevision

Effective DateJuly 1, 2026

Next Review DateN/A

Key ActionSubmit documentation of an eligible diagnosis, the required specialist prescriber, and meningococcal vaccination for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearMaximum authorization length

3Covered eculizumab products

4Clinical indication pathways

2 weeksVaccination interval before first Soliris dose

Coverage Criteria

Initial Therapy Criteria

Initial therapy is covered when all applicable requirements are met.

Initial therapy requirements

Eligible indication and prescriber pathway
- PNH or aHUS: Supporting documentation indicates paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome (aHUS), and the prescribing physician is a hematologist.
- Generalized myasthenia gravis: Supporting documentation indicates generalized myasthenia gravis (gMG), the patient is anti-acetylcholine receptor positive, and the prescribing physician is a neurologist.
- Neuromyelitis optica spectrum disorder: Supporting documentation indicates neuromyelitis optica spectrum disorder (NMOSD), the patient is aquaporin-4 antibody positive, the requested product is Soliris, and the prescribing physician is a neurologist.
  Soliris only.
Meningococcal vaccination: The patient has been vaccinated against meningococcal infection caused by Neisseria meningitidis. If not previously vaccinated, the patient must receive meningococcal vaccination at least 2 weeks before the first Soliris dose.At least 2 weeks before first Soliris dose
Vaccination must be verified through medical claims, progress notes, or vaccination records.

Continuation Therapy Criteria

Continuation therapy is covered when all of the following are met.

Continuation therapy requirements

Initial criteria met: The patient has met initial review criteria.
Clinical response: A clinical response is documented with therapy.
Safety: The patient has not experienced any treatment-restricting adverse effects.
Appropriate dosing: Dosing is appropriate according to labeling or is supported by compendia.

Provider Actions and Documentation

Prior Authorization

Initial Clinical Authorization

Initial clinical authorization is required for eligible indications and must be supported by the appropriate specialist prescriber and meningococcal vaccination status.

Paroxysmal nocturnal hemoglobinuria (PNH) or atypical hemolytic uremic syndrome (aHUS): prescribing physician must be a hematologist.
Generalized myasthenia gravis (gMG): patient must be anti-acetylcholine receptor positive and the prescribing physician must be a neurologist.
Neuromyelitis optica spectrum disorder (NMOSD): patient must be aquaporin-4 antibody positive, the prescribing physician must be a neurologist, and this indication applies to Soliris only.
Patient must have been vaccinated against meningococcal infection (Neisseria meningitidis). If not previously vaccinated, vaccination must occur at least 2 weeks before the first Soliris dose.

Documentation Required

Clinical and Vaccination Documentation

Initial Therapy Criteria

Initial therapy requires one eligible indication pathway, the required specialist prescriber, and meningococcal vaccination.

Initial therapy

Indication pathways
- PNH or aHUS is documented and the prescribing physician is a hematologist.
- Generalized myasthenia gravis (gMG) is documented, the patient is anti-acetylcholine receptor positive, and the prescribing physician is a neurologist.
- Neuromyelitis optica spectrum disorder (NMOSD) is documented, the patient is aquaporin-4 antibody positive, the prescribing physician is a neurologist, and Soliris is requested.
  Soliris only.

Continuation Criteria

Continuation Therapy Criteria

Continuation therapy requires all criteria below.

Continuation therapy

Initial review criteria: The patient has met initial review criteria.
Documented response: A clinical response is documented with therapy.
Treatment safety: The patient has not experienced any treatment-restricting adverse effects.
Dosing is appropriate according to labeling or is supported by compendia.

Denial Risk

Failure to Meet Clinical or Vaccination Criteria

Authorization may be denied when the clinical indication, required specialist prescriber, antibody status, or meningococcal vaccination requirement is not established in the submitted documentation.

Deny when documentation does not support PNH, aHUS, gMG, or NMOSD as applicable to the requested product.
Deny when the prescriber does not meet the required specialty: hematologist for PNH or aHUS, or neurologist for gMG or NMOSD.
Deny gMG requests without documentation of anti-acetylcholine receptor positivity or NMOSD requests without documentation of aquaporin-4 antibody positivity; NMOSD is covered only for Soliris.
Deny when meningococcal vaccination cannot be verified or, for a previously unvaccinated patient receiving Soliris, vaccination was not administered at least 2 weeks before the first dose.