CurrentCareSourcePolicy N/A

Vyvgart (efgartigimod alfa-fcab) intravenous for generalized myasthenia gravis

Defines prior authorization criteria, dosing, and coverage limitations for Vyvgart Intravenous for adult patients with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis; applies to medical benefit utilization management for CareSource members.

Policy Summary

PayerCareSource

PolicyVyvgart (efgartigimod alfa-fcab) intravenous for generalized myasthenia gravis

Policy CodePolicy N/A

Change TypeMaterial and operational updates (added Vyvgart Hytrulodosing interval clarified)

Effective Date

Next Review DateJul 24, 2024

Key ActionSubmit prior authorization with documentation of age, antibody status, MG-ADL score, pyridostigmine use or intolerance, dosing plan, and evidence of unresolved symptoms or benefit for continuation.

SourceLink

POLICY UPDATE CHANGES

Added Vyvgart Hytrulo to the criterion for patients currently receiving Vyvgart so the criteria apply to patients receiving Vyvgart or Vyvgart Hytrulo.

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

Moved examples of unresolved symptoms of generalized myasthenia gravis into a Note and provided examples (e.g., difficulty swallowing, breathing, double vision).

Adults ≥18Age requirement for approval

MG-ADL ≥5Minimum disease activity score

10 mg/kg or 1200 mgInduction dosing options

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Recommended Authorization Criteria

Initial and continuation therapy

Covered when ALL of the following are met:

Age: Patient is >= 18 years of age

Antibody status: Patient has confirmed anti-acetylcholine receptor antibody-positive generalized myasthenia gravis

MGFA class: Myasthenia Gravis Foundation of America (MGFA) clinical classification II to IV

Disease activity: MG-ADL total score >= 5MG-ADL >=5

Pyridostigmine use: Patient received or is currently receiving pyridostigmine OR has inadequate efficacy, a contraindication, or significant intolerance to pyridostigmine

Dosing regimen: Induction: for patients <120 kg: 10 mg/kg IV once weekly x4 OR for patients >=120 kg: 1200 mg IV once weekly x4; subsequent treatment based on clinical evaluationDose as specified

Treatment cycles no more frequent than every 50 days from start of previous treatment cycle

Ongoing symptoms or benefit: Patient has evidence of unresolved symptoms of generalized myasthenia gravis (examples: difficulty swallowing, difficulty breathing, double vision, impairment of speech, mobility, or respiratory function) OR, for continuation, prescriber states patient is continuing to derive benefit from Vyvgart Intravenous (or Vyvgart Hytrulo)

Examples provided in policy

Prescriber: Medication is prescribed by or in consultation with a neurologist

Coverage of Vyvgart Intravenous in combination with another neonatal Fc receptor blocker, a complement inhibitor, or a rituximab product is not recommended. The policy states there is no evidence to support concomitant use of Vyvgart Intravenous with these agents and lists examples of each class to aid review.

Requests that do not meet one of the situations described in the Recommended Authorization Criteria are not recommended for coverage. The policy explicitly notes that coverage is not recommended for circumstances not listed and that criteria will be updated as new published data become available.

There is no evidence to support use of Vyvgart Intravenous in combination with other neonatal Fc receptor blockers, complement inhibitors, or rituximab products. The policy therefore does not recommend approval for concomitant administration of Vyvgart Intravenous with these agents and provides examples of complement inhibitors (e.g., eculizumab, ravulizumab, zilucoplan) and neonatal Fc receptor blockers (e.g., rozanolixizumab, Vyvgart Hytrulo) to clarify the exclusion.

Dosing, Scoring, and Interval Requirements

MG-ADL score — eligibility threshold

MG-ADL minimum for approvalMG-ADL total score >= 5

ContextRequired as part of initial and continuation therapy criteria for generalized myasthenia gravis

Assessment toolMyasthenia Gravis Activities of Daily Living (MG-ADL) total score (0–24) assesses 8 signs/symptoms

Dosing weight threshold

Weight >= 120 kgUse fixed dose 1200 mg IV once weekly x4 (induction)

Weight < 120 kgUse weight-based dose 10 mg/kg IV once weekly x4 (induction)

Subsequent dosing

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Requirement

Prior Authorization Required. Prior authorization is required for Vyvgart Intravenous (efgartigimod alfa) medical benefit coverage. Approvals will be granted only when the patient meets the clinical and dosing criteria specified in the policy. Requests for doses or regimens outside the established dosing in this policy will be reviewed case-by-case by a clinician (e.g., Medical Director or Pharmacist). All approvals are provided for the duration noted in the authorization; when duration is expressed in months, 1 month = 30 days.

Documentation Required

Required Prescriber and Clinical Documentation

Prescriber and clinical documentation must be submitted with the prior authorization request. The medication must be prescribed by, or in consultation with, a neurologist or a physician who specializes in the treatment of myasthenia gravis. Documentation should include: patient age, antibody status (anti-acetylcholine receptor positive or other), MG-ADL score, evidence of unresolved symptoms (examples: difficulty swallowing, breathing, speech, double vision, impaired mobility), description of prior and current myasthenia gravis therapies and response, and dosing regimen requested. Continued-therapy requests should include prescriber attestation that the patient is continuing to derive clinical benefit.

Clinical Background

Myasthenia gravis is an autoimmune neuromuscular disorder characterized by fatigable skeletal muscle weakness that commonly affects ocular, bulbar, limb, and respiratory muscles. Vyvgart (efgartigimod alfa-fcab) is a neonatal Fc receptor blocker approved for adults with anti‑acetylcholine receptor antibody‑positive generalized myasthenia gravis and demonstrated improved clinical response rates in randomized trials.

For prior authorization and coverage decisions, the policy focuses on adults (≥18 years) with confirmed anti‑acetylcholine receptor antibody‑positive generalized myasthenia gravis, Myasthenia Gravis Foundation of America (MGFA) class II–IV, and clinically meaningful disease activity as measured by the MG‑ADL score. The policy also specifies induction dosing (10 mg/kg IV weekly ×4 or 1200 mg IV weekly ×4 for patients ≥120 kg) and limits treatment cycles to be no more frequent than every 50 days from the start of the previous treatment cycle.

The policy excludes concomitant use with other neonatal Fc receptor blockers, complement inhibitors, or rituximab products due to lack of supporting evidence, and it requires documentation of unresolved symptoms (for continued treatment) or clinical benefit, prescriber specialty, antibody status, MG‑ADL score, and prior use or intolerance of pyridostigmine.

Definitions and Clinical Terms

MG-ADL responder definition

Responder definition>=2-point reduction in total MG-ADL score from baseline for at least 4 consecutive weeks

Timing of first reductionFirst reduction must occur no later than 1 week after the last infusion of the cycle

Trial evidenceUsed as primary responder endpoint in pivotal randomized trial (67.7% Vyvgart vs 29.7% placebo)

Unresolved symptoms (examples)

Examples of unresolved symptomsDifficulty swallowing (dysphagia)

Respiratory involvementDifficulty breathing or impaired respiratory function

Ocular and functional impairments