CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Zilbrysq (zilucoplan) for generalized myasthenia gravis

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This policy governs pharmacy prior authorization and coverage of Zilbrysq (zilucoplan) for adult members with generalized myasthenia gravis who are antiacetylcholine receptor antibody positive. It defines initial authorization, quantity, dosing, reauthorization, and non-covered off-label use requirements.

Policy Summary

Payercaresourcegeorgia

PolicyZilbrysq (zilucoplan) for generalized myasthenia gravis

Policy CodePolicy GA-MED-P-366579

Change TypeRevised

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization with documentation of MGFA class II-IV disease, AChR antibody seropositivity, a failed conventional therapy trial, and meningococcal vaccination.

SourceLink

POLICY UPDATE CHANGES

The required corticosteroid trial before initial authorization was changed from at least 3 months to at least 4 weeks.

18+Minimum age for initial authorization

6 monthsInitial authorization period

12 monthsReauthorization period

28/28 daysQuantity limit

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CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Zilbrysq (zilucoplan) for generalized myasthenia gravis

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Policy Summary

Payercaresourcegeorgia

PolicyZilbrysq (zilucoplan) for generalized myasthenia gravis

Policy CodePolicy GA-MED-P-366579

Change TypeRevised

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization with documentation of MGFA class II-IV disease, AChR antibody seropositivity, a failed conventional therapy trial, and meningococcal vaccination.

SourceLink

POLICY UPDATE CHANGES

The required corticosteroid trial before initial authorization was changed from at least 3 months to at least 4 weeks.

18+Minimum age for initial authorization

6 monthsInitial authorization period

12 monthsReauthorization period

28/28 daysQuantity limit

MGFA II-IVCovered severity classes

Coverage Criteria

Initial Therapy

Covered for initial authorization when ALL of the following are met:

ALL of the following

Member is at least 18 years of age.
Medication is prescribed by or in consultation with a neurologist.
Member has a documented diagnosis of MGFA class II-IV myasthenia gravis (see appendix).
Lab results documented in the chart notes show that the member is seropositive for acetylcholine receptor (AChR) antibodies.
At least ONE conventional therapy has been tried and failed
- Pyridostigmine.
- Corticosteroid for at least 4 weeks.
- Non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months.
Member has received meningococcal vaccine.
Zilucoplan is administered subcutaneously once daily according to actual body weight: <56 kg: 16.6 mg; 56 to <77 kg: 23 mg; or 77 kg or greater: 32.4 mg.
Quantity limit is 28 syringes per 28 days.

Continuation Therapy

Covered for reauthorization when the following requirement is met:

ALL of the following

Chart notes document clinically meaningful improvement in symptom severity and daily functioning compared to the pretreatment baseline (e.g., improved MG-ADL or QMG scores).

Zilbrysq (zilucoplan) is not covered for the treatment of conditions or indications that are not listed in this document. For any other indication, please refer to the Off-Label policy.

CareSource considers Zilbrysq (zilucoplan) not medically necessary for conditions that are not listed in this document.

Provider Actions and Authorization Requirements

Prior Authorization

Initial Zilbrysq Authorization

Prior authorization is required for Zilbrysq (zilucoplan) to treat generalized myasthenia gravis. Submit documentation confirming the initial authorization requirements below; when all requirements are met, approval is granted for 6 months.

Member is at least 18 years of age.
Zilbrysq is prescribed by or in consultation with a neurologist.
Member has MGFA class II-IV myasthenia gravis and is seropositive for AChR antibodies.
Member has received meningococcal vaccination.
Dosing is subcutaneous once daily based on actual body weight: <56 kg: 16.6 mg; 56 to <77 kg: 23 mg; 77 kg or greater: 32.4 mg.
Quantity limit: 28 syringes per 28 days.

Prior Authorization

Zilbrysq Reauthorization

For reauthorization, submit chart notes showing clinically meaningful improvement in symptom severity and daily functioning compared with the member’s pre-treatment baseline. If this requirement is met, coverage may be approved for an additional 12 months.

Clinical Background

Myasthenia gravis is an autoimmune disorder of the neuromuscular junction that causes fluctuating muscle weakness and fatigue. Autoantibodies most commonly target acetylcholine receptors, impairing neuromuscular transmission and potentially affecting ocular motility, swallowing, speech, mobility, and respiratory function.

MGFA Class Definitions

MGFA Clinical Classification

MGFA Class IAny ocular weakness; all other muscle strength is normal.

MGFA Clinical Classification

MGFA Class IIMild weakness affecting muscles other than the ocular muscles; ocular weakness may also be present at any level.

MGFA Clinical Classification

MGFA Class IIIModerate weakness affecting muscles other than the ocular muscles; ocular weakness may also be present at any level.

MGFA Clinical Classification

Initial Authorization Criteria

For initial authorization, all of the following requirements must be met:

Initial authorization requirements

Age: Member is at least 18 years of age.
Prescriber: Medication is prescribed by or in consultation with a neurologist.
Diagnosis: Member has a documented diagnosis of MGFA class II-IV myasthenia gravis.MGFA class II-IV

Reauthorization Criteria

Reauthorization

For reauthorization, the following requirement must be met:

Reauthorization response: Chart notes document clinically meaningful improvement in symptom severity and daily functioning compared with the pre-treatment baseline.

Improved MG-ADL or QMG scores may demonstrate improvement. If met, approval is for an additional 12 months.

Conventional Therapy Step

Step	Requirement	Qualifying conventional therapies
1	Before initial Zilbrysq authorization, the member must have tried and failed at least one conventional therapy.	Pyridostigmine; a corticosteroid for at least 4 weeks; or a non-steroid immunosuppressant (such as azathioprine) for at least 6 months.

Quantity and Supply Limits

Quantity Limits

Zilbrysq (zilucoplan)28 syringes per 28 days

Policy Summary

Payercaresourcegeorgia

PolicyZilbrysq (zilucoplan) for generalized myasthenia gravis

Policy CodePolicy GA-MED-P-366579

Change TypeRevised

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit pharmacy prior authorization with documentation of MGFA class II-IV disease, AChR antibody seropositivity, a failed conventional therapy trial, and meningococcal vaccination.

SourceLink

On This Page

Step Therapy

Conventional Therapy Trial Required

Document that the member has tried and failed at least one conventional therapy before initial Zilbrysq authorization.

Pyridostigmine; or
A corticosteroid trial for at least 4 weeks; or
A non-steroid immunosuppressant, such as azathioprine, for at least 6 months.

Documentation Required

Initial Clinical Documentation

Include the clinical records needed to establish the diagnosis and prior treatment history for initial authorization.

MGFA classification must be documented as class II-IV myasthenia gravis.
Chart notes must include a laboratory result showing seropositivity for acetylcholine receptor (AChR) antibodies.
Document the member’s prior conventional-therapy trial and failure, including the applicable treatment and duration.
Document meningococcal vaccination.
The prescription must be from a neurologist or provided in consultation with a neurologist.

Documentation Required

Reauthorization Response Documentation

For continuation of therapy, the chart note must compare the member’s current status with the pre-treatment baseline and substantiate meaningful clinical response.

Document improvement in symptom severity.
Document improvement in daily functioning.
Include objective or structured measures when available, such as improved MG-ADL or QMG scores.

Unsupported block type: denial_risk

MGFA Class IVSevere weakness affecting muscles other than the ocular muscles; ocular weakness may also be present at any level.

MGFA Clinical Classification

MGFA Class VDefined by intubation, with or without mechanical ventilation.

A laboratory result in the chart shows that the member is seropositive for AChR antibodies.

ONE of the following conventional therapies has been tried and failed

Pyridostigmine: Member has tried and failed pyridostigmine.
Corticosteroid: Member has tried and failed a corticosteroid for at least 4 weeks.>= 4 weeks
Non-steroid immunosuppressant: Member has tried and failed a non-steroid immunosuppressant, such as azathioprine, for at least 6 months.>= 6 months

Vaccination: Member has received meningococcal vaccine.