CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Vyvgart and Vyvgart Hytrulo Coverage for Generalized Myasthenia Gravis and CIDP

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CareSource Georgia Medicaid medical and pharmacy prior authorization coverage for Vyvgart and Vyvgart Hytrulo in adults with generalized myasthenia gravis or chronic inflammatory demyelinating polyneuropathy, including diagnosis, specialist, treatment-history, dosing, quantity-limit, reauthorization, and non-covered-indication requirements.

Policy Summary

PayerCareSource Georgia Medicaid

PolicyVyvgart and Vyvgart Hytrulo Coverage for Generalized Myasthenia Gravis and CIDP

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial update

Effective DateMarch 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization for Vyvgart and medical or pharmacy prior authorization for Vyvgart Hytrulo.

SourceLink

POLICY UPDATE CHANGES

The policy added Vyvgart Hytrulo as a covered product and added a chronic inflammatory demyelinating polyneuropathy indication.

The policy added the Vyvgart Hytrulo prefilled syringe formulation and pharmacy benefit type as an authorization option.

The generalized myasthenia gravis corticosteroid treatment-failure requirement was revised to at least 4 weeks.

The policy added treatment-cycle spacing requirements for generalized myasthenia gravis reauthorization and subsequent cycles.

2Covered disease indications

50 daysMinimum gMG cycle interval

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CurrentcaresourcegeorgiaPolicy GA-MED-P-366579

Vyvgart and Vyvgart Hytrulo Coverage for Generalized Myasthenia Gravis and CIDP

Customize your policy alerts

Sign up for caresourcegeorgia Policy GA-MED-P-366579 alerts

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Policy Summary

PayerCareSource Georgia Medicaid

PolicyVyvgart and Vyvgart Hytrulo Coverage for Generalized Myasthenia Gravis and CIDP

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial update

Effective DateMarch 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization for Vyvgart and medical or pharmacy prior authorization for Vyvgart Hytrulo.

SourceLink

POLICY UPDATE CHANGES

The policy added Vyvgart Hytrulo as a covered product and added a chronic inflammatory demyelinating polyneuropathy indication.

The policy added the Vyvgart Hytrulo prefilled syringe formulation and pharmacy benefit type as an authorization option.

The generalized myasthenia gravis corticosteroid treatment-failure requirement was revised to at least 4 weeks.

The policy added treatment-cycle spacing requirements for generalized myasthenia gravis reauthorization and subsequent cycles.

2Covered disease indications

50 daysMinimum gMG cycle interval

6 monthsInitial gMG authorization

4 monthsInitial CIDP authorization

4 per 28 daysVyvgart Hytrulo quantity limit

Not coveredUnlisted indications

Medical Necessity and Coverage Criteria

Initial generalized myasthenia gravis therapy

Covered for initial generalized myasthenia gravis authorization when all criteria are met.

Initial gMG authorization

Member and prescriber requirements: Member is at least 18 years of age and medication is prescribed by or in consultation with a neurologist.Age >=18
Diagnosis and serology: Member has a documented diagnosis of MGFA class II-IV myasthenia gravis and laboratory evidence of AChR antibody seropositivity.MGFA class II-IV; AChR antibody positive
Conventional therapy failure: Member has 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.At least 1 therapy; corticosteroid >=4 weeks; non-steroid immunosuppressant >=6 months
Dosing and quantity requirements: The requested product is administered once weekly for 4 weeks as one cycle, and the applicable product dose and quantity limit are followed.Vyvgart: 10 mg/kg if weight <120 kg or 1,200 mg if weight >=120 kg; Vyvgart quantity limit: 12 vials per 28 days; Vyvgart Hytrulo quantity limit: 4 vials or 4 syringes per 28 days
Vyvgart is administered by IV infusion; Vyvgart Hytrulo is administered by subcutaneous injection. Subsequent cycles may occur no sooner than 50 days from the start of the previous cycle.

Continuation therapy for generalized myasthenia gravis

Covered for generalized myasthenia gravis reauthorization when all criteria are met.

gMG reauthorization: Chart notes document clinically meaningful improvement in symptom severity and daily functioning compared with the pretreatment baseline, and treatment cycles are prescribed at least 50 days apart.Cycle interval >=50 days

Examples of improvement include improved MG-ADL or QMG scores. When criteria are met, approval is for an additional 12 months.

Initial CIDP therapy

Covered for initial CIDP authorization when all criteria are met. This section applies to Vyvgart Hytrulo only.

Initial CIDP authorization

Member and prescriber requirements: Member is at least 18 years of age and medication is prescribed by or in consultation with a neurologist.Age >=18
CIDP diagnosis and functional impact: CIDP is confirmed by electrodiagnostic studies using motor and sensory nerve conduction studies; symptoms of motor weakness and/or sensory disturbances have been present for at least 2 months; and disabling symptoms impair activities of daily living.Symptoms >=2 months
Prior CIDP therapy failure: Member has tried and failed at least two of the following therapies for at least 3 months each: oral or intravenous corticosteroid; IVIG or SCIG; or plasma exchange.

Continuation therapy for CIDP

Covered for CIDP reauthorization when the continuation criterion is met.

CIDP reauthorization: Member has improvement of neuromuscular disability and impairment, with sustained stability since initiation of therapy.Improvement and sustained stability documented

When the criterion is met, approval is for an additional 12 months.

For chronic inflammatory demyelinating polyneuropathy (CIDP), Vyvgart Hytrulo coverage excludes members with pure sensory atypical CIDP.

The CIDP coverage criteria apply to Vyvgart Hytrulo only. Vyvgart is not identified as covered for CIDP under this policy.

Vyvgart and Vyvgart Hytrulo are not medically necessary for treatment of conditions or indications not listed in this policy. For other indications, refer to the Off-Label policy.

Initial Authorization Requirements

Reauthorization Requirements

gMG reauthorization

gMG reauthorization requires all listed continuation criteria.

Clinical response and cycle timing: Chart notes document clinically meaningful improvement in symptom severity and daily functioning compared with the pretreatment baseline, such as improved MG-ADL or QMG scores; and treatment cycles are prescribed at least 50 days apart.Cycle interval >=50 days

When criteria are met, approval is for an additional 12 months.

CIDP reauthorization

CIDP reauthorization requires the following clinical response.

Clinical response: Member has improvement of neuromuscular disability and impairment, with sustained stability since initiation of therapy.Improvement and sustained stability documented

Required Prior Treatment

Condition	Step requirement	Qualifying therapies
Generalized myasthenia gravis	Tried and failed at least 1 conventional therapy	Pyridostigmine; corticosteroid for at least 4 weeks; or non-steroid immunosuppressant (e.g., azathioprine) for at least 6 months

Condition	Step requirement	Qualifying therapies
Chronic inflammatory demyelinating polyneuropathy (CIDP)	Tried and failed at least 2 therapies, each for at least 3 months	Corticosteroid (oral or IV); immune globulin (IVIG or SCIG); or plasma exchange

Product and Quantity Limits

Quantity limit

ProductVyvgart

Quantity limit12 vials per 28 days

Administration scheduleOnce weekly for 4 weeks (1 cycle)

Quantity limit

Product and formulationVyvgart Hytrulo vial

Quantity limit4 vials per 28 days

Administration scheduleOnce-weekly subcutaneous injection

Administration Setting and Route

Billing Rule

Infusion Center — Vyvgart IV Administration

Vyvgart is administered by intravenous infusion in an infusion-center setting. A neurologist must be involved in prescribing and management, and providers should verify dosing and quantity limits before administration.

Once weekly for 4 weeks (1 cycle); subsequent cycles may begin no sooner than 50 days after the start of the prior cycle.
Weight <120 kg: 10 mg/kg; weight ≥120 kg: 1,200 mg (3 vials).
Quantity limit: 12 vials per 28 days; exceeding the limit requires plan review and authorization before dispensing or administration.
When requirements are met, approval may be issued for 6 months.

Billing Rule

Home — Vyvgart Hytrulo Subcutaneous Administration

Vyvgart Hytrulo is administered by subcutaneous injection in the home setting using either the vial or prefilled syringe formulation. A neurologist must be involved in prescribing and management, and providers should verify quantity limits before dispensing.

Dosing, Timing, and Treatment Thresholds

gMG treatment-cycle interval

Treatment cycleOnce weekly for 4 weeks

Minimum intervalSubsequent cycles may take place no sooner than 50 days from the start of the previous cycle

Applies toGeneralized myasthenia gravis

Vyvgart weight-based dose

Weight less than 120 kg10 mg/kg

Weight 120 kg or greater1,200 mg

ProductVyvgart

Authorization, Documentation, and Denial Risks

Prior Authorization

Obtain prior authorization

Obtain prior authorization before treatment. Vyvgart requires medical prior authorization; Vyvgart Hytrulo requires medical or pharmacy prior authorization.

Prior Authorization

Involve a neurologist

Ensure the medication is prescribed by or in consultation with a neurologist for generalized myasthenia gravis or CIDP.

Step Therapy

Document conventional therapy failure

For generalized myasthenia gravis, document that the member tried and failed at least one conventional therapy.

Pyridostigmine

Disease Background

Myasthenia gravis is an autoimmune disorder of the neuromuscular junction characterized by muscle weakness and fatigue. It commonly involves antibodies against the acetylcholine receptor. Vyvgart reduces pathogenic IgG autoantibody levels by inhibiting IgG recycling through the neonatal Fc receptor.

MGFA Clinical Classification

MGFA Class I

Ocular weaknessAny ocular weakness

Other muscle strengthNormal strength in all other muscles

ClassificationMGFA Class I

MGFA Class II

Weakness severityMild weakness

Muscles affectedMuscles other than the ocular muscles

Ocular weaknessMay occur at any level

Policy Summary

PayerCareSource Georgia Medicaid

PolicyVyvgart and Vyvgart Hytrulo Coverage for Generalized Myasthenia Gravis and CIDP

Policy CodePolicy GA-MED-P-366579

Change TypeMaterial update

Effective DateMarch 1, 2026

Next Review DateN/A

Key ActionSubmit medical prior authorization for Vyvgart and medical or pharmacy prior authorization for Vyvgart Hytrulo.

SourceLink

On This Page

At least 2 of 3 therapies; each >=3 months

CIDP subtype requirement: Member does not have pure sensory atypical CIDP.Not pure sensory atypical CIDP

Dosing and quantity requirements: Vyvgart Hytrulo is administered subcutaneously once weekly using the applicable vial or prefilled syringe formulation, within the applicable quantity limit.4 vials or 4 syringes per 28 days

Vyvgart Hytrulo only. When criteria are met, approval is for 4 months.

When the criterion is met, approval is for an additional 12 months.

Quantity limit

Product and formulationVyvgart Hytrulo prefilled syringe (PFS)

Quantity limit4 syringes per 28 days

Administration scheduleOnce-weekly subcutaneous injection

Vial: 1,008 mg/11,200 units subcutaneously once weekly; quantity limit of 4 vials per 28 days.
Prefilled syringe: 1,000 mg/10,000 units subcutaneously once weekly; quantity limit of 4 syringes per 28 days.
Quantity-limit exceedance requires plan review and authorization before dispensing.
When requirements are met, initial approval may be issued for 4 months.

CIDP symptom duration

ConditionChronic inflammatory demyelinating polyneuropathy (CIDP)

Required symptom durationAt least 2 months

Symptoms coveredMotor weakness and/or sensory disturbances

Corticosteroid trial for gMG

TherapyCorticosteroid

Required trial durationAt least 4 weeks

RequirementTried and failed at least 1 conventional therapy

Non-steroid immunosuppressant trial for gMG

TherapyNon-steroid immunosuppressant, such as azathioprine

Required trial durationAt least 6 months

RequirementTried and failed at least 1 conventional therapy

CIDP prior-therapy duration

ConditionChronic inflammatory demyelinating polyneuropathy (CIDP)

Required durationAt least 3 months for each therapy

Minimum number of therapiesAt least 2 specified therapies

Corticosteroid for at least 4 weeks

Non-steroid immunosuppressant, such as azathioprine, for at least 6 months

Step Therapy

Document CIDP treatment failure

For CIDP, document that the member tried and failed at least two qualifying therapies for at least 3 months each.

Corticosteroid, oral or intravenous
Immune globulin, IVIG or SCIG
Plasma exchange

Documentation Required

Submit gMG diagnostic history

Submit chart documentation of MGFA class II-IV myasthenia gravis, laboratory evidence of AChR antibody seropositivity, and prior treatment with at least one conventional therapy.

Document MGFA class II-IV disease.
Include the laboratory result showing AChR antibody seropositivity.
Document prior treatment with at least one conventional therapy.

Documentation Required

Support gMG reauthorization

For generalized myasthenia gravis reauthorization, submit chart notes documenting clinically meaningful improvement in symptom severity and daily functioning compared with the pretreatment baseline, and document treatment-cycle timing.

Include evidence such as improved MG-ADL or QMG scores.
Show that treatment cycles are prescribed at least 50 days apart.

Documentation Required

Submit CIDP diagnostic history

Submit electrodiagnostic confirmation of CIDP using motor and sensory nerve conduction studies, symptoms of motor weakness and/or sensory disturbances for at least 2 months, activities-of-daily-living impairment, and qualifying prior-treatment failures.

Document symptoms present for at least 2 months.
Document impairment of activities of daily living due to disabling symptoms.
Document failure of at least two specified therapies for at least 3 months each.

Documentation Required

Support CIDP reauthorization

For CIDP reauthorization, submit documentation of improvement in neuromuscular disability and impairment, with sustained stability since initiation of therapy.

Denial Risk

Avoid unlisted indications

Coverage may be denied when Vyvgart or Vyvgart Hytrulo is requested for a condition or indication not listed in the policy. For any other indication, refer to the Off-Label policy.

Denial Risk

Check for atypical sensory CIDP

CIDP requests may be denied when the member has pure sensory atypical CIDP.

Denial Risk

Stay within quantity limits

Keep requests within the stated dosage and quantity limits; requests exceeding those limits may be denied.

Vyvgart: 12 vials per 28 days.
Vyvgart Hytrulo vial: 4 vials per 28 days.
Vyvgart Hytrulo prefilled syringe: 4 syringes per 28 days.

Denial Risk

Meet reauthorization criteria

Reauthorization may be denied when required clinical improvement or sustained stability is not documented, or when generalized myasthenia gravis cycles are prescribed less than 50 days apart.

For gMG, document clinically meaningful improvement in symptom severity and daily functioning compared with the pretreatment baseline.
For CIDP, document improvement in neuromuscular disability and impairment with sustained stability since therapy initiation.
For gMG, confirm cycles are at least 50 days apart.

MGFA Class III

Weakness severityModerate weakness

Muscles affectedMuscles other than the ocular muscles

Ocular weaknessMay occur at any level

MGFA Class IV

Weakness severitySevere weakness

Muscles affectedMuscles other than the ocular muscles

Ocular weaknessMay occur at any level

MGFA Class V

ClassificationMGFA Class V

Defining featureDisease severity defined by intubation

Mechanical ventilationWith or without mechanical ventilation