CurrentCignaPolicy IP0376

Neurology - Vyvgart Intravenous

Policy governs prior authorization, coverage criteria, dosing, and exclusions for Vyvgart IV for adults with generalized myasthenia gravis under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyNeurology - Vyvgart Intravenous (Vyvgart Intravenous, efgartigimod alfa-fcab)

Policy CodePolicy IP0376

Change TypeAnnual revision — material clarifications and timing limits

Effective DateAug 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization with required documentation (including confirmation of anti‑AChR antibody positivity) before initiating Vyvgart IV.

SourceLink

POLICY UPDATE CHANGES

Added requirement that treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle.

Documentation instruction updated to require confirmation of anti-acetylcholine receptor antibody positive status with documentation required.

Policy title changed from 'Efgartigimod Intravenous' to 'Neurology - Vyvgart Intravenous.'

Imaavy was added to examples of neonatal Fc receptor blockers in the not-covered list.

Added 'biosimilars to Soliris' to examples of complement inhibitors in the not-covered list.

67.7% vs 29.7%MG-ADL responder rate

≥18Minimum age

10 mg/kg or 1200 mgRecommended dosing

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Coverage Criteria for Vyvgart Intravenous

FDA-Approved Indication — Initial Therapy

Approve for 6 months if the patient meets ALL of the following:

Initial Therapy Criteria: Patient is ≥ 18 years of age; AND Patient has confirmed anti-acetylcholine receptor antibody positive generalized myasthenia gravis [documentation required]; AND Patient meets BOTH of the following: (a) Myasthenia Gravis Foundation of America (MGFA) classification II to IV; AND (b) Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 5; AND Patient meets ONE of the following: (a) received or is currently receiving pyridostigmine; OR (b) has had inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine; AND Patient has evidence of unresolved symptoms of generalized myasthenia gravis (examples include difficulty swallowing, difficulty breathing, or functional disability such as double vision, impaired speech, or impaired mobility); AND Treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle; AND The medication is being prescribed by or in consultation with a neurologist.

Documentation of anti-AChR positive status and MG-ADL/MGFA assessments is required per policy.

FDA-Approved Indication — Continuing Therapy

Approve for 1 year if the patient meets ALL of the following:

Continuing Therapy Criteria: Patient is ≥ 18 years of age; AND According to the prescriber, the patient is continuing to derive benefit from Vyvgart Intravenous (examples of benefit include reductions in exacerbations of myasthenia gravis and improvements in speech, swallowing, mobility, or respiratory function); AND Treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle; AND The medication is being prescribed by or in consultation with a neurologist.

Documentation of clinical benefit is required for continuing therapy approval.

Dosing Criteria (applies to initial and continuing therapy)

Approve only if BOTH dosing conditions are met:

Dose by weight: Patient < 120 kg: 10 mg/kg administered by intravenous infusion once weekly for 4 weeks; OR Patient ≥ 120 kg: 1200 mg administered by intravenous infusion once weekly for 4 weeks.Weight cutoff 120 kg

Administer infusions over one hour as recommended; subsequent cycles based on clinical evaluation.

Cycle frequency: Treatment cycles are no more frequent than every 50 days from the start of the previous treatment cycle.>=50 days between cycle starts

The safety of initiating subsequent cycles sooner than 50 days has not been established; applies to initial and continuing therapy.

Concomitant use of Vyvgart Intravenous with another neonatal Fc receptor blocker, a complement inhibitor, or a rituximab product is considered not medically necessary. The policy states there is no evidence to support concurrent use of these agents and provides examples to clarify the exclusion.

Examples of neonatal Fc receptor blockers listed in the policy include Imaavy (nipocalimab-aahu), Rystiggo (rozanolixizumab-noli), and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). Examples of complement inhibitors include eculizumab (Soliris) and its biosimilars, Ultomiris (ravulizumab-cwvz), and Zilbrysq (zilucoplan).

Use of Vyvgart Intravenous for any indication other than anti-acetylcholine receptor (anti-AChR) antibody‑positive generalized myasthenia gravis in adults is considered not medically necessary. The Conditions Not Covered section specifies that other uses are excluded and that the list may be updated as new evidence becomes available.

Coding and Billing

Considered Medically Necessary HCPCSHCPCSCovered

J9332

Injection, efgartigimod alfa-fcab, 2 mg

inv-07: Weight-based dosing cutoff

Weight-based dosing cutoffPatients weighing < 120 kg: 10 mg/kg IV once weekly for 4 weeks; Patients weighing ≥ 120 kg: 1200 mg IV once weekly for 4 weeks.

Subsequent cycles timingSubsequent treatment cycles based on clinical evaluation; safety not established if initiating cycles sooner than 50 days from the start of the previous cycle.

Infusion durationAdminister 10 mg/kg infusion over one hour for patients < 120 kg.

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization Required. Prior authorization is required for benefit coverage of Vyvgart Intravenous. Approvals are time-limited: initial approvals for 6 months and continuing therapy approvals for 1 year. All approvals are provided for the duration noted in the policy (when months are used, 1 month = 30 days). Vyvgart Intravenous must be prescribed by or in consultation with a neurologist or a physician who specializes in the condition being treated.

Initial approval duration: 6 months
Continuation approval duration: 1 year
Approvals measured in months: 1 month = 30 days
Prescriber requirement: neurologist or specialist

Prior Authorization

Pyridostigmine Requirement

Pyridostigmine requirement: For initial therapy, the patient must have received or be currently receiving pyridostigmine, OR there must be documentation of inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine. This requirement must be documented in the prior authorization request.

Definitions and Clinical Measures

inv-13: Generalized myasthenia gravis (AChR-positive)

Disease definitionGeneralized myasthenia gravis is a chronic autoimmune neuromuscular disease caused by pathogenic IgG autoantibodies against neuromuscular junction components leading to fatigable skeletal muscle weakness.

Anti-AChR–positive prevalenceApproximately 85% of patients with myasthenia gravis are anti-acetylcholine receptor (anti-AChR) antibody–positive.

Typical clinical featuresOften affects bulbar, ocular, limb, and respiratory muscles, causing symptoms such as ptosis, diplopia, dysphagia, dysarthria, limb weakness, and respiratory compromise.

inv-14: MG-ADL responder

Responder definitionMG-ADL responder: a patient with a ≥2-point reduction in total MG-ADL score compared to the treatment cycle baseline for at least 4 consecutive weeks.

Timing of first reduction

Background

Myasthenia gravis is a chronic autoimmune neuromuscular disease caused by pathogenic IgG autoantibodies, most commonly directed against the acetylcholine receptor (AChR), that produce fatigable skeletal muscle weakness affecting bulbar, ocular, limb, and respiratory muscles. Vyvgart (efgartigimod alfa-fcab) is an Fc neonatal Fc receptor (FcRn) blocker indicated for adults with anti-AChR antibody‑positive generalized myasthenia gravis and has demonstrated improved MG-ADL responder rates in clinical trials.